santyl and propylene glycol
 

Pills
 

ED Pills

ED Drugs
 

Santyl Ointment


Pronunciation: COL-a-geh-nase
Generic Name: Collagenase
Brand Name: Santyl
Santyl Ointment is used for:

Removing dead skin from wounds and burned areas.

Santyl Ointment is an enzymatic debriding ointment. It works by breaking down dead skin.

Do NOT use Santyl Ointment if: you are allergic to any ingredient in Santyl Ointment

Contact your doctor or health care provider right away if any of these apply to you.

Before using Santyl Ointment:

Some medical conditions may interact with Santyl Ointment. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you are in very poor health

Some MEDICINES MAY INTERACT with Santyl Ointment. Tell your health care provider if you are taking any other medicines, especially any of the following:

Products that contain mercury or silver (eg, certain antiseptics) because they may decrease Santyl Ointment's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Santyl Ointment may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Santyl Ointment:

Use Santyl Ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Cleanse the affected area as directed with normal saline or an appropriate cleanser before you apply Santyl Ointment. Ask your doctor if you have questions about appropriate cleansers. If you are also using an antibiotic powder, apply it to the affected area before you apply Santyl Ointment. Follow your doctor's instructions for using Santyl Ointment. You may be instructed to apply it directly to the wound, or to a sterile gauze pad that will then be applied to the wound. Ask your doctor if you have questions about how to use Santyl Ointment. Do not get Santyl Ointment on the healthy skin around the affected area. If you miss a dose of Santyl Ointment, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Santyl Ointment.

Important safety information: Check with your doctor before you use any other medicines on the affected area. This includes cleansers and soaking solutions. Some of these products may decrease Santyl Ointments effectiveness. Santyl Ointment should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Santyl Ointment while you are pregnant. If you are or will be breast-feeding while you use Santyl Ointment, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Santyl Ointment:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Santyl Ointment. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); signs of infection (eg, fever, chills, or persistent sore throat).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Santyl side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Santyl Ointment:

Store Santyl Ointment below 77 degrees F (25 degrees C). Store away from heat and light. Keep Santyl Ointment out of the reach of children and away from pets.

General information: If you have any questions about Santyl Ointment, please talk with your doctor, pharmacist, or other health care provider. Santyl Ointment is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Santyl Ointment. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Santyl resources Santyl Side Effects (in more detail) Santyl Use in Pregnancy & Breastfeeding Santyl Drug Interactions Santyl Support Group 0 Reviews for Santyl - Add your own review/rating Compare Santyl with other medications Actinic Keratosis
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PanOxyl 5 Aquagel 5%w / w Gel


1. Name Of The Medicinal Product

PanOxyl 5 Aquagel 5%w/w Gel

PanOxyl Aquagel 5

2. Qualitative And Quantitative Composition

Benzoyl peroxide 5% w/w. Also contains propylene glycol.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Gel

4. Clinical Particulars 4.1 Therapeutic Indications

The product is indicated for use in the topical treatment of acne vulgaris.

4.2 Posology And Method Of Administration

Treatment should normally begin with PanOxyl Aquagel 2.5. Apply to the affected areas once daily. Washing prior to application enhances the efficacy of the preparation.

The reaction of the skin to benzoyl peroxide differs in individual patients. The higher concentration in PanOxyl Aquagel 5 or 10 may be required to produce a satisfactory response.

4.3 Contraindications

PanOxyl Aquagel should not be prescribed for patients with a known hypersensitivity to benzoyl peroxide.

4.4 Special Warnings And Precautions For Use

Avoid contact with the eyes, mouth and mucous membranes. Care should be taken when applying the product to the neck and other sensitive areas.

During the first few days of treatment a moderate reddening and peeling will occur. During the first few weeks of treatment a sudden increase in peeling will occur in most patients. This is not harmful and will normally subside within a day or two if treatment is discontinued. If excessive irritation, redness or peeling occurs, discontinue use.

The product may bleach dyed fabrics.

PanOxyl 5 Aquagel contains propylene glycol. Propylene glycol may cause skin irritation.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None

4.6 Pregnancy And Lactation

There are no restriction on the use of PanOxyl Aquagel in pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None

4.8 Undesirable Effects

None

4.9 Overdose

Not applicable.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Benzoyl peroxide has sebostatic and keratolytic activity coupled with antibacterial activity against Propionibacterium acnes, the organism implicated in acne vulgaris. Its use in the treatment of acne is well established.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Not applicable. Benzoyl peroxide has been in widespread use for many years.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Carbomer 940

Di-isopropanolamine

Propylene glycol

Polyoxyethylene lauryl ether

Sodium lauryl sulphate

Purified water

6.2 Incompatibilities

None

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

Internally lacquered aluminium tubes with screw caps. Licensed pack sizes: 40g and 50g.

6.6 Special Precautions For Disposal And Other Handling

There are no special instructions for use or handling of PanOxyl Aquagel 5.

7. Marketing Authorisation Holder

GlaxoSmithKline UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

Trading as Stiefel

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

8. Marketing Authorisation Number(S)

PL 19494/0058

9. Date Of First Authorisation/Renewal Of The Authorisation

21st August 1984

10. Date Of Revision Of The Text

18 October 2011


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Clear Up Prep



Dosage Form: gel
Drug Facts ACTIVE INGREDIENT

Salicylic Acid 2% w/w.

INACTIVE INGREDIENTS

WATER • SORBITOL • ETHOXYDIGLYCOL • GLYCOLIC ACID • METHYL GLUCETH-20 • SODIUM CITRATE • GLYCERIN • LACTIC ACID • SODIUM HYDROXIDE • CELLULOSE GUM • XANTHAN GUM • ETHYLHEXYLGLYCERIN • PROPYLENE GLYCOL • PHENOXYETHANOL • CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT • HEDERA HELIX (IVY) EXTRACT • SAPONARIA OFFICINALIS EXTRACT •
ARCTIUM LAPPA ROOT EXTRACT • SALVIA OFFICINALIS (SAGE) LEAF EXTRACT •

DIRCETIONS

Cover the eyes with cotton pads soaked in Blue Water. With the fingertips, apply evenly to the face and neck Clear Up Prep Lotion, making sure to avoid the lips.

Application: 2-3 minutes | Pause: 7-8 minutes

WARNINGS

Enter section text here

image of carton label
image of tube 5ml label

Enter section text here

Keep out of reach of children.

Enter section text here


Clear Up Prep 
salicylic acid  gel Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 62499-395 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 2 g  in 100 g Inactive Ingredients Ingredient Name Strength WATER   SORBITOL   DIETHYLENE GLYCOL MONOETHYL ETHER   GLYCOLIC ACID   METHYL GLUCETH-20   SODIUM CITRATE   GLYCERIN   LACTIC ACID   SODIUM HYDROXIDE   PROPYLENE GLYCOL   PHENOXYETHANOL   CARBOXYMETHYLCELLULOSE SODIUM   XANTHAN GUM   ETHYLHEXYLGLYCERIN   LEMON OIL   SAPONARIA OFFICINALIS ROOT   ARCTIUM LAPPA ROOT   SAGE OIL   Product Characteristics Color blue (dark bleu) Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 62499-395-11 1 TUBE In 1 CARTON contains a TUBE (62499-395-10) 1 62499-395-10 5 g In 1 TUBE This package is contained within the CARTON (62499-395-11)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 07/01/2010
Labeler - Laboratoire Dr. Renaud (202501565) Revised: 07/2010Laboratoire Dr. Renaud
More Clear Up Prep resources Clear Up Prep Side Effects (in more detail) Clear Up Prep Use in Pregnancy & Breastfeeding Clear Up Prep Drug Interactions Clear Up Prep Support Group 1 Review for Clear Up Prep - Add your own review/rating Compare Clear Up Prep with other medications Acne Dermatological Disorders Warts
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Codeine Phosphate and Guaifenesin



Codeine Phosphate 10 mg Guaifenesin 200 mg Drug Facts

Active ingredients (in each 5 mL teaspoonful)
Codeine Phosphate* 10 mg ........ Antitussive
*WARNING: May be habit forming
Guaifenesin 200 mg ................. Expectorant

Uses

·    temporarily relieves these symptoms due to the common cold:
·    cough due to minor throat and bronchial irritation
·    helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Warnings

Do not exceed recommended dosage.
Do not use this product
·    do not take this product if you have chronic pulmonary disease, shortness of breath,or children who are taking other drugs, unless directed by a doctor.
Ask a doctor before use if you have
·    a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
·    a cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
·    cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
·    new symptoms occur
·    may cause or aggravate constipation
If pregnant or breast-feeding, ask a health professional before use.
Keep out of the reach of children.
In case of accidental overdose, seek professional assistance, or contact a Poison Control Center immediately.

Directions Take this medication with a full glass of water after each dose to help loosen mucus in the lungs.
Inactive ingredients Cherry Flavor, Citric Acid, Glycerin, Menthol
Crystals, Propylene Glycol, Purified Water,
Sodium Citrate, Sodium Saccharin, Sorbitol,
and Vanilla Flavor.
Other information
Store at 68° - 77° F (20° - 25° C)
Questions? Comments?
Call 1-866-934-6025
Manufactured for:
Kylemore Pharmaceuticals, LLC
Port St. Joe, FL 32456
323-10 Rev. 12/09 PACKAGING:

Codeine Phosphate 10 mg Guaifenesin 200 mg labeling:


CODEINE PHOSPHATE GUAIFENESIN 
codeine phosphate, guaifenesin  liquid Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 49769-323 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CODEINE PHOSPHATE (CODEINE) CODEINE PHOSPHATE 10 mg  in 5 mL GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg  in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE   GLYCERIN   MENTHOL   PROPYLENE GLYCOL   WATER   SODIUM CITRATE   SACCHARIN SODIUM   SORBITOL   Product Characteristics Color      Score      Shape Size Flavor CHERRY (cherry-vanilla) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 49769-323-16 473 mL In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2010 11/30/2012
Labeler - Kylemore Pharmaceuticals, LLC (831892471) Revised: 03/2011Kylemore Pharmaceuticals, LLC
More Codeine Phosphate and Guaifenesin resources Codeine Phosphate and Guaifenesin Side Effects (in more detail)Codeine Phosphate and Guaifenesin DosageCodeine Phosphate and Guaifenesin Use in Pregnancy & BreastfeedingDrug ImagesCodeine Phosphate and Guaifenesin Drug InteractionsCodeine Phosphate and Guaifenesin Support Group21 Reviews for Codeine Phosphate and Guaifenesin - Add your own review/rating Compare Codeine Phosphate and Guaifenesin with other medications Cough
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Scot-Tussin Expectorant SF Cough


guaifenesin
Dosage Form: oral liquid
Scot-Tussin Expectorant SF Cough Active Ingredient: 

Each teaspoonful (5 ml) contains:

Guaifenesin 100mg

Purpose

Expectorant

Uses Helps loosen phlegm (mucus) to make coughs more productive thereby relieving chest congestion. Warnings Do not exceed recommended dosage.
*Phenylketonurics: Contains Phenylalanine. When using this product Do not exceed recommended dosage. Ask a doctor before use if you have a Cough that occurs with too much phlegm (mucus).
a Chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema. Stop use and ask a doctor if Cough lasts more than seven days, returns or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding,

Do Not Use.

Keep out of reach of children.

In case of overdose get medical help or contact a Poison Control Center right away.

Directions: Follow Dosage Chart.
Do not exceed six doses in any 24 hour period. Adults 2-4 teaspoonfuls (10-20 ml)
every 4 hours Children 12 years
and older Consult a Doctor Children Under
12 years old DO NOT USE Other Information Store at 20? – 25? C (68? – 77? F). Inactive Ingredients

Aspartame* (see warning) Benzoic Acid, Citric Acid, Clear Grape Flavor, Glycerin, Hydroxypropylmethylcellulose, Menthol, Methyl-Paraben, Propyl-Paraben, Propylene Glycol, Purified Water, *Phenylketonurics: Contains Phenylalanine.

PRINCIPAL DISPLAY PANEL

NDC 0372-0006-04

SCOT-TUSSIN

EXPECTORANT

COUGH

For DIABETICS since 1956

SUGAR-FREE

LOOSENS &

RELIEVES

CHEST

CONGESTION

100%

SUGAR-FREE
HIGH BLOOD PRESSURE SAFE
LACTOSE-FREE
ALCOHOL-FREE
SODIUM-FREE
CLEAR
GLUTEN-FREE

Scot-Tussin

STRIVING FOR PERFECTION

4 FL OZ (118 ml)


Scot-Tussin Expectorant SF Cough 
guaifenesin  liquid Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0372-0006 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg  in 5 mL Inactive Ingredients Ingredient Name Strength ASPARTAME   BENZOIC ACID   CITRIC ACID MONOHYDRATE   GLYCERIN   HYPROMELLOSE   MENTHOL   METHYLPARABEN   PROPYLPARABEN   PROPYLENE GLYCOL   WATER   Product Characteristics Color      Score      Shape Size Flavor GRAPE Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0372-0006-04 118 mL In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 07/01/1974
Labeler - SCOT-TUSSIN Pharmacal Co., Inc. (001203918) Revised: 04/2009SCOT-TUSSIN Pharmacal Co., Inc.
More Scot-Tussin Expectorant SF Cough resources Scot-Tussin Expectorant SF Cough Side Effects (in more detail) Scot-Tussin Expectorant SF Cough Dosage Scot-Tussin Expectorant SF Cough Use in Pregnancy & Breastfeeding Scot-Tussin Expectorant SF Cough Support Group 0 Reviews for Scot-Tussin Expectorant SF Cough - Add your own review/rating Compare Scot-Tussin Expectorant SF Cough with other medications Bronchitis Cough
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Boots Pharmacy Cold & Flu Night Liquid


Boots Pharmacy Cold & Flu Night Liquid

Specifically to: Give full strength dose of paracetamol Relieve congestion and reduce coughing Relieve fever, aches and pains Aid restful sleep

240 ml e

Read all of this carton for full instructions.

This medicine is made specially for night-time and contains a combination of ingredients to give you relief from the major symptoms of colds and flu. It relieves fever, aches and pains, nasal congestion, dry, tickly coughs and helps you sleep.

Before you take this medicine

Contains Paracetamol
Do not take with any other paracetamol-containing products.
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

Warning: May cause drowsiness. If affected, do not drive or operate machinery. Avoid alcoholic drink.

Do not take: If you are allergic to any of the ingredients If you have heart disease or have high blood pressure (including that due to a tumour near your kidneys) If you suffer from diabetes, an overactive thyroid, glaucoma If you suffer from severe kidney disease, liver failure, long term lung problems e.g. bronchitis or bronchiectasis If you are taking monoamine oxidase inhibitors (for depression) or have taken them within the last 14 days If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains maltitol liquid) If you are a man with prostate problems If you are pregnant or breastfeeding Talk to your pharmacist or doctor: If you have asthma If you have other kidney or liver problems (including a disease caused by drinking alcohol) If you are on a controlled sodium diet (each 30 ml contains 33 mg of sodium) If you take other medicines Medicines for heart problems (e.g. digoxin) Medicines for high blood pressure Barbiturates (for epilepsy) Sleeping tablets Strong pain killers, sedatives, tranquillisers, tricyclic antidepressants Atropine Metoclopramide or domperidone (for feeling sick) Colestyramine (to reduce blood fat levels) Warfarin or other blood thinners If you suffer from alcoholism, epilepsy, brain injury or disease (this medicine contains alcohol which may be harmful to you)

Do not drink alcohol (wine, beers, spirits) whilst taking this medicine (propylene glycol may enhance the effects of alcohol).

Information about some of the ingredients:

Each 30 ml contains 1169 mg of alcohol (ethanol) equivalent to 29 ml of beer or 12 ml of wine.

Glycerol may cause headache, stomach upset and diarrhoea.

How to take this medicine

Check the seal is not broken before first use. If it is, do not take the medicine.

Take at bedtime only. Use the measuring cup provided.

Adults and children of 12 years and over

Take 30 ml

At bedtime only

This medicine should be swallowed

Do not give to children under 12 years.

Warning:

Do not exceed stated dose.

Do not take this medicine for more than 7 days unless your doctor tells you to.

If symptoms persist consult your doctor.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these serious side effects, stop taking the medicine.

See a doctor at once: Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions) These other effects are less serious.

If they bother you talk to a pharmacist:

Drowsiness, tiredness, dizziness, muscular weakness Feeling sick, being sick, diarrhoea, constipation, stomach upset, stomach pains Headache, blurred vision, ringing in the ears, loss of appetite Irritability, nightmares, hallucinations (particularly in children) Fast heart rate, shaking, difficulty in passing urine, dry mouth, phlegm on the chest, sweating Skin rash Unusual bruising or infections such as sore throats – this may be a sign of very rare changes in the blood.

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25°C.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredients

Each 30 ml of oral solution contains Diphenhydramine Hydrochloride 25 mg, Paracetamol 1000 mg, Pholcodine 10 mg, Pseudoephedrine Hydrochloride 60 mg.

Also contains: glycerol (E422), propylene glycol, maltitol liquid (E965), purified water, ethanol (4.8 vol %), citric acid, sodium citrate, sodium benzoate (E211), acesulfame potassium, quinoline yellow (E104), patent blue V (E131), flavours (peppermint, aniseed (containing benzyl alcohol, propylene glycol)).

PL 00014/0571

P

Text prepared 3/08

Manufactured for the Marketing Authorisation holder Boots Pharmacy Nottingham NG2 3AA

by

The Boots Company PLC Nottingham NG2 3AA

If you need more advice ask your pharmacist.

BTC19179 vF 28/08/08


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X-Viate Gel


urea
Dosage Form: gel
X-VIATE™ 40% CREAM
(Urea 40% in a cream base)
X-VIATE™ 40% LOTION
(Urea 40% in a lotion base)
X-VIATE™ 40% GEL
(Urea 40% in a gel base)

Rx only

For external use only.

Not for ophthalmic use.

X-Viate Gel Description

X-VIATE™ is a potent keratolytic emollient which is a gentle tissue softener for skin and/or nails.

Each gram of X-VIATE™ 40% CREAM contains 40% Urea in a cream base of Carbopol, Cetyl Alcohol, Glyceryl Monostearate, Light Mineral Oil, Propylene Glycol, Purified Water, Sodium Hydroxide, White Petrolatum and Xanthan Gum.

Each gram of X-VIATE™ 40% LOTION contains 40% Urea in a lotion base of Carbopol, Cetyl Alcohol, Glyceryl Stearate, Methyl Paraben, Mineral Oil, Propyl Paraben, Propylene Glycol, Purified Water, Trolamine, White Petrolatum and Xanthan Gum.

Each gram of X-VIATE™ 40% GEL contains 40% Urea in a gel base of Hydroxyethyl Cellulose, Methyl Paraben, Propylene Glycol and Purified Water.

CHEMISTRY

Urea is a diamide of carbonic acid with the following chemical structure:

X-Viate Gel - Clinical Pharmacology

Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.

PHARMACOKINETICS

The mechanism of action of topically applied Urea is not yet known.

INDICATIONS AND USES:

For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or prurient debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.

Contraindications

Known hypersensitivity to any of the listed ingredients.

Warnings

For external use only. Avoid contact with eyes, lips or mucous membranes.

Precautions

If redness or irritation occurs, discontinue use. After applying this medication, wash hands and unaffected areas thoroughly. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

PREGNANCY Pregnancy Category B

Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, X-VIATE™should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS

It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when X-VIATE™ is administered to a nursing woman.

Adverse Reactions

Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.

X-Viate Gel Dosage and Administration

Apply X-VIATE™ to affected skin twice per day or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue twice per day or as directed by a physician.

How is X-Viate Gel Supplied

X-VIATE™ 40% CREAM (40% Urea) is supplied in:

28.5g (1 oz) tube 58980-625-10 85g (3 oz) tube 58980-625-30 199g (7 oz) tube 58980-625-70

X-VIATE™ 40% LOTION (40% Urea) is supplied in:

237mL (8 oz) bottle 58980-623-80

X-VIATE™ 40% GEL (40% Urea) is supplied in:

15mL bottle 58980-624-15

Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.

Distributed by:
Stratus Pharmaceuticals Inc,
Miami, Florida 33186-6727
Toll free: 800-442-7882
www.stratuspharmaceuticals.com

Manufactured by:
Sonar Products, Inc., Carlstadt, NJ 07072

PG-KVG-IN 2009-0608

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

X-VIATE 40% GEL

NDC 58980-624-15

X-VIATE™
40% GEL

Gentle, potent,
tissue softener,
for nail and skin

Rx only

UREA 40%
IN A GEL BASE

Distributed by
STRATUS

NET WT 15 mL Bottle
with Applicator Brush


X-VIATE 
urea  gel Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 58980-624 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Urea (Urea) Urea 6.726 g  in 15 mL Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400   Methylparaben   Water   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 58980-624-15 1 VIAL In 1 BOX contains a VIAL, GLASS 1 15 mL In 1 VIAL, GLASS This package is contained within the BOX (58980-624-15)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 05/03/2006
Labeler - Stratus Pharmaceuticals, Inc (789001641) Establishment Name Address ID/FEI Operations Sonar Products Inc 104283945 MANUFACTURE Revised: 10/2011Stratus Pharmaceuticals, Inc More X-Viate Gel resources X-Viate Gel Side Effects (in more detail)X-Viate Gel Use in Pregnancy & BreastfeedingX-Viate Gel Support Group2 Reviews for X-Viate - Add your own review/rating Compare X-Viate Gel with other medications Dermatological DisordersDry SkinPityriasis rubra pilaris
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Xylocaine 10mg Spray


Xylocaine 10 mg Spray

lidocaine

Read all of this leaflet carefully before Xylocaine spray is given to you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, dentist or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or dentist. In this leaflet: 1. What Xylocaine Spray is and what it is used for 2. Before Xylocaine Spray is given to you 3. How Xylocaine Spray is given to you 4. Possible side effects 5. How to store Xylocaine Spray 6. Further information What Xylocaine Spray is and what it is used for

The name of your medicine is ‘Xylocaine 10 mg Spray’. It is referred to as ‘Xylocaine Spray’ in the rest of this leaflet.

Xylocaine Spray contains a medicine called lidocaine. This belongs to a group of medicines called local anaesthetics.

Xylocaine Spray is used to numb (anaesthetise) parts of the body. It stops pain happening during:

Medical examinations and operations of the nose and throat. Childbirth, and after the birth if stitches are needed. Treatment at the dentist. Before Xylocaine Spray is given to you You must not be given Xylocaine Spray if: You are allergic (hypersensitive) to lidocaine or any of the other ingredients of Xylocaine Spray (see Section 6: Further information). You are allergic to any other local anaesthetics of the same class (such as prilocaine or bupivacaine).

You must not be given Xylocaine Spray if any of the above apply to you. If you are not sure, talk to your doctor or dentist before you are given Xylocaine Spray.

Take special care with Xylocaine Spray

Check with your doctor or dentist before having Xylocaine Spray if:

You have any cuts, sores or ulcers in your throat, mouth or nose. You have a chest infection. You have epilepsy. You have heart problems such as a slow heart beat. You have very low blood pressure. You have liver or kidney problems. You have ever been told that you have a rare disease of the blood pigment called ‘porphyria’ or anyone in your family has it.

If you are not sure if any of the above apply to you, talk to your doctor before having Xylocaine Spray.

Taking other medicines

Please tell your doctor or dentist if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Xylocaine Spray can affect the way some medicines work and some medicines can have an effect on Xylocaine Spray.

In particular, tell your doctor or dentist if you are taking any of the following medicines:

Medicines used to treat an uneven heart beat (arrhythmia) such as mexiletine. Pregnancy and breast-feeding

Before you are given Xylocaine Spray, tell your doctor or dentist if you are pregnant, planning to get pregnant, or if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines Xylocaine Spray may affect you being able to drive or use tools or machines. This depends on where in the body Xylocaine Spray is used and how much is used. Your doctor or dentist will tell you when it is safe for you to do these activities. Important information about some of the ingredients of Xylocaine Spray Xylocaine Spray contains saccharin. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before using this medicine. The banana flavouring in Xylocaine Spray contains propylene glycol. Propylene glycol may cause skin irritation. How Xylocaine Spray is given to you Xylocaine Spray will usually be given to you by a doctor or dentist. The dose that your doctor or dentist gives you will depend on the type of pain relief that you need. It will also depend on your age and physical condition. If you are given Xylocaine Spray to take home, you must use the dose recommended by your doctor or dentist. Always use Xylocaine Spray exactly as your doctor or dentist has told you. You should check with them if you are not sure. How to use Xylocaine Spray Do not use more than 20 sprays. You should use as few sprays as possible. Do not get the spray in your eyes. The spray nozzle is bent so that it works properly. Do not try to change the shape of the nozzle or it might break. How to use Xylocaine Spray in the mouth and throat When Xylocaine Spray is used in the mouth and throat it causes a loss of feeling. This makes it more likely that food or liquid may go down the wrong way. Also, this may make it difficult to swallow or cause some people to accidentally bite their tongue or cheek. Xylocaine Spray should be used with care in the elderly, in people who are in poor general health and in children. Cleaning the nozzle

Do not shorten the nozzle. Otherwise the spray will not work properly. If you need to clean the nozzle:

Remove the nozzle from the spray bottle. Place the nozzle in boiling water for 5 minutes. Remove the nozzle from the water. Then dry the nozzle and replace it on top of the bottle. If you use more Xylocaine Spray than you should

If you think you have used more Xylocaine Spray than you should, talk to your doctor or dentist immediately.

Possible side effects

Like all medicines, Xylocaine Spray may cause side effects although not everybody gets them.

Severe allergic reactions:

If you have a severe allergic reaction, tell your doctor immediately. The signs may include sudden onset of:

Swelling of your face, lips, tongue or throat. This may make it difficult to swallow. Severe or sudden swelling of your hands, feet and ankles. Difficulty breathing. Severe itching of the skin (with raised lumps). Other possible side effects: Irritation where Xylocaine Spray has been used. Feeling nervous. Feeling dizzy. Feeling sleepy. Loss of consciousness. Sore throat. Hoarse voice or loss of voice. Low blood pressure. This might make you feel dizzy or light-headed. Fits (seizures). Difficulty breathing or slow breathing. Slow heart beat. Stopped breathing or a stopped heart beat.

Do not be concerned by this list of possible side effects. You may not get any of them.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or dentist.

How to store Xylocaine Spray Keep out of the reach and sight of children. Do not use after the expiry date which is stated on the bottle after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. At temperatures below 8°C the spray solution may start to go solid. This will dissolve when the spray solution is warmed up gently to room temperature. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment. Further information What Xylocaine Spray contains

The active ingredient is lidocaine. Each dose of spray contains 10 mg of lidocaine.

The other ingredients are ethanol, levomenthol, macrogol 400, essence of banana (contains propylene glycol), saccharin and purified water.

What Xylocaine Spray looks like and contents of the pack

Xylocaine Spray is a pump spray. It comes in a 50 ml bottle. Each bottle contains about 500 sprays.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Xylocaine Spray is held by

AstraZeneca UK Ltd 600 Capability Green Luton LU1 3LU UK

Xylocaine Spray is manufactured by

AstraZeneca UK Limited Silk Road Business Park Macclesfield Cheshire SK10 2NA UK

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name Reference Number
Xylocaine Spray 17901/0177

This is a service provided by the Royal National Institute of Blind People.

Leaflet prepared: November 2009.

© AstraZeneca 2009.

Xylocaine is a trade mark of the AstraZeneca group of companies.

PAI 09 0051a

P026382


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Childrens Cetirizine Oral Solution



CHILDREN'S
CETIRIZINE
HYDROCHLORIDE
ORAL SOLUTION
1 mg/1 mL
Antihistamine

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Cetirizine HCl 5 mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose itchy, watery eyes sneezing itching of the nose or throat Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

if breast-feeding: not recommended if pregnant: ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions use only with enclosed dosing cup adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and older 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. children 2 to under 6 years of age 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information store between 20° to 25°C (68° to 77°F) Inactive ingredients

artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucrose

Questions?

Call 1-866-923-4914

Distributed by: Chain Drug Consortium, LLC
2300 NW Corporate BLVD., Suite 115
Boca Raton, FL 33431
Made in Israel

PRINCIPAL DISPLAY PANEL - 120 mL bottle carton

NDC 68016-023-43

Ages
two years
and older

Compare to
the active ingredient
in Children's Zyrtec®*

Premier
Value®

CHILDREN'S
CETIRIZINE
HYDROCHLORIDE
ORAL SOLUTION
1 mg/1 mL
Antihistamine

Grape Flavored Syrup

24 hour Allergy Relief of:
Sneezing; Runny Nose;
Itchy,Watery Eyes;
Itchy Throat or Nose

Indoor & Outdoor Allergies

Dosing Cup
Included

PV
PREMIER VALUE GUARANTEE

4 FL OZ (120 mL)


CHILDRENS CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride  solution Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 68016-023 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride 5 mg  in 5 mL Inactive Ingredients Ingredient Name Strength acetic acid   glycerin   methylparaben   propylene glycol   propylparaben   water   sodium acetate anhydrous   sucrose   Product Characteristics Color YELLOW (colorless to slightly yellow) Score      Shape Size Flavor GRAPE, BANANA Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 68016-023-43 1 BOTTLE In 1 CARTON contains a BOTTLE 1 120 mL In 1 BOTTLE This package is contained within the CARTON (68016-023-43)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090182 04/22/2008
Labeler - Chain Drug Consortium, LLC (Premier Value) (101668460) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Operations Taro Pharmaceutical Industries Ltd. 600072078 ANALYSIS, MANUFACTURE Revised: 04/2010Chain Drug Consortium, LLC (Premier Value)
More Childrens Cetirizine Oral Solution resources Childrens Cetirizine Oral Solution Side Effects (in more detail) Childrens Cetirizine Oral Solution Use in Pregnancy & Breastfeeding Drug Images Childrens Cetirizine Oral Solution Drug Interactions Childrens Cetirizine Oral Solution Support Group 73 Reviews for Childrens Cetirizine - Add your own review/rating Compare Childrens Cetirizine Oral Solution with other medications Hay Fever Urticaria
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U40 Foam


urea
Dosage Form: aerosol, foam
U40 Foam U40 Foam Description

U40 Foam is a keratolytic emollient in a water and lipid-based foam which is a gentle, but potent, tissue softener for skin and nails.
U40 Foam contains the active ingredient: Urea 40%. The inactive ingredients are: Carbomer, Colloidal Oatmeal, Dimethicone, Ethylparaben, Glycerine, Laureth 4, Methylparaben, Phenoxyethanol, Polysorbate 20, Propylparaben, Propylene Glycol, Purified Water, Stearic Acid and Triethanolamine and in propellants Butane and Propane.
CHEMICAL STRUCTURE
Urea has the following chemical structure:

U40 Foam - Clinical Pharmacology

Urea, topically applied, dissolves the intercellular matrix of the skin which can result in enhanced shedding of scaly, dry skin which causes a softening of the hyperkeratotic areas of the skin. Applied to the nail plate topically, urea has a similar effect on the intercellular matrix of the nail plate.

PHARMACOKINETICS

The mechanism of action of topically applied urea is not yet known.

Indications and Usage for U40 Foam

For enzymatic debridement and promotion of normal healing of surface lesions, particularly where healing is halted by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea, topically applied, is useful for the treatment of hyperkeratotic conditions such as dermatitis, xerosis, ichthyosis, psoriasis, eczema, keratosis, keratoderma and dry, rough skin, as well as corns and calluses. It is also useful in the treatment of damaged, ingrown and devitalized nails.

Contraindications

Known hypersensitivity to any of the listed ingredients.

Warnings U40 Foam is for external use only. It is not for ophthalmic, oral, anal or intravaginal use. Contact with eyes, lips and all mucous membranes should be avoided. U40 Foam should not be used by persons who have a known hypersensitivity to urea or any of the other listed ingredients.
Precautions U40 Foam should only be used as directed by a physician and should not be used to treat any condition other than that for which it is prescribed. If redness or irritation occurs, discontinue use and consult with prescribing physician.
Pregnancy (Category C): Animal reproduction studies have not been performed with topically applied urea and it is not known whether U40 Foam can cause fetal harm when administered to pregnant women. U40 Foam should be used by pregnant women, only under a physician’s recommendation.
Nursing Mothers: It is not known whether topically applied urea is excreted in human milk. Due to the fact that many drugs are excreted in human milk, caution should be exercised by physicians when administering U40 Foam to nursing mothers.
KEEP THIS AND ALL OTHER MEDICATIONS OUT OF THE REACH OF CHILDREN. Adverse Reactions Transient stinging, burning, itching or irritation is possible.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. U40 Foam Dosage and Administration Unless otherwise directed by a prescribing physician, U40 Foam should be applied to affected area twice a day. U40 Foam should be rubbed into the skin until it is completely absorbed.
How is U40 Foam Supplied

U40 Foam, NDC 49769-354-75, is supplied as (2) 2.63 oz (75 g), net wt. 5.26 oz (150 g), aerosolized canisters in a carton, NDC 49769-354-15.

U40 Foam is supplied in a 2.5 oz (70 g) aerosolized canister, NDC 49769-354-70.

Store at controlled room temperature 15?C - 25?C (59?F - 77?F).
Manufactured for
Kylemore Pharmaceuticals
Port St. Joe, FL 32456
Iss. 12/09
354-10

PACKAGING:

U40 Foam (75g) labeling:

U40 Foam (70g) labeling:


U40 
urea  aerosol, foam Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 49769-354 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UREA) UREA 400 mg  in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER 934   OATMEAL   DIMETHICONE   ETHYLPARABEN   GLYCERIN   LAURETH-4   METHYLPARABEN   PHENOXYETHANOL   POLYSORBATE 20   PROPYLPARABEN   PROPYLENE GLYCOL   WATER   STEARIC ACID   TROLAMINE   PROPANE   BUTANE   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 49769-354-15 150 g In 1 CARTON None 2 49769-354-70 70 g In 1 CANISTER None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/05/2010 06/30/2012
Labeler - Kylemore Pharmaceuticals, LLC (831892471) Revised: 03/2011Kylemore Pharmaceuticals, LLC More U40 Foam resources U40 Foam Side Effects (in more detail)U40 Foam Use in Pregnancy & Breastfeeding0 Reviews for U40 - Add your own review/rating Compare U40 Foam with other medications Dermatological DisordersDry SkinPityriasis rubra pilaris
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Feldene Gel


UNITED KINGDOM

Feldene Gel 5mg/g

piroxicam

Read all of this leaflet carefully before you start using this medicine Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Feldene Gel is and what it is used for 2. Before you use Feldene Gel 3. How to use Feldene Gel 4. Possible side effects 5. How to store Feldene Gel 6. Further information What Feldene Gel is and what it is used for

Feldene Gel is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). This means it will help to relieve pain and reduce swelling affecting joints and muscles when rubbed into the skin over the affected area.

Feldene Gel is for the treatment of rheumatism, sprains, strains and mild osteoarthritis of joints (knees, wrists, ankles etc).

Do not use Feldene Gel If you have ever had an allergic reaction to Feldene Gel, any other form of piroxicam, aspirin or any other medicines used to treat painful joints and muscles. This may have been itching, reddening of the skin or difficulty in breathing. Use Feldene Gel with special care

Medicines are not always suitable for everyone. Your doctor needs to know before you use Feldene Gel if you suffer from or have suffered in the past from any of the following conditions:

liver disease. kidney disease.

Feldene Gel is not recommended for use in children under 12 years of age.

Taking other medicines

Feldene Gel is not known to interact with any other medicines. However, you should still tell your doctor about any other medicines you are taking or have recently taken including medicines you bought yourself without a prescription.

Pregnancy and Breast-feeding

If you are pregnant or breast feeding tell your doctor before you use Feldene Gel.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Feldene Gel is not expected to affect your ability to drive or use machines.

Important information about some of the ingredients of Feldene Gel

Feldene Gel contains propylene glycol which may cause skin irritation.

How to use Feldene Gel

Always use Feldene Gel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Feldene Gel is for external use on the skin only.

Pierce the tube by reversing the cap and screwing down to break the seal on the tube.

Apply 3cm (one and a quarter inches approximately) of the Gel on the affected area. Use the scale below as a guide. Rub the Gel into the skin until the Gel disappears. Do this three or four times a day. If there is no improvement in your symptoms, tell your doctor.

Do not use Feldene Gel for more than four weeks without telling your pharmacist or doctor.

Do not rub your medication into damaged skin, for example wounds, scratches, infections or dermatitis. Do not apply near eyes, nose, mouth, genital or anal (bottom) areas. If the Gel does come into contact with these areas, rinse away with water.

Do not cover the area where Feldene Gel has been rubbed in with dressings or bandages.

After using Feldene Gel 1. Always replace the cap 2. Wash your hands If you use too much or accidentally swallow Feldene Gel

If you accidentally use too much Feldene Gel this is unlikely to cause any side effects.

If a large amount of your medication is swallowed accidentally, tell your doctor immediately, or contact your nearest hospital casualty department.

If you forget to use Feldene Gel

If you forget to use Feldene Gel, use it as soon as you remember unless it is time for your next application. Do not use double the amount to make up for a missed application.

If you stop using Feldene Gel

Your pain may return if you stop using Feldene Gel.

If you have any further questions on how to take this product, ask your doctor or pharmacist.

Feldene Gel Side Effects

Like all medicines, Feldene Gel can cause side effects, although not everybody gets them.

Tell your doctor immediately and stop using Feldene Gel if you experience any of the following symptoms after taking this medicine. Although they are very rare, these symptoms can be serious:

sudden wheeziness, difficulty in breathing, fever, swelling of eyelids, face or lips, rash or itching affecting the whole body Other side effects that Feldene Gel may cause are: Redness, rash and/or itching of the skin where Feldene Gel was rubbed in (for example eczema, contact dermatitis) Reaction of the skin to sunlight Uncommon side effects are: Nausea (feeling sick) Indigestion Stomach discomfort

These effects should disappear if you stop using Feldene Gel. If the discomfort continues tell your doctor or pharmacist.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Feldene Gel

Keep Feldene Gel out of the reach and sight of children

Do not store above 30oC.

Do not use Feldene Gel after the expiry date which is stamped on the tube. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information What Feldene Gel contains

Each gram of Feldene Gel contains 5mg piroxicam as the active substance.

Other ingredients are benzyl alcohol, carbopol 980, di-isopropanolamine, ethyl alcohol, hydroxy-ethyl cellulose, propylene glycol and water.

What Feldene Gel looks like and contents of the pack

Feldene Gel is clear, odourless and non-sticky. Each tube of Feldene contains either 60g or 112g of Feldene Gel.

Marketing Authorisation Holder Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UK Manufacturer Farmasierra Manufacturing S.L. Carretera de Irun Km 26.200 E-28700 San Sebastian de los Reyes Spain Company Contact Address

For further information on your medicine please contact Medical Information at the following address:

Pfizer Ltd Walton Oaks Dorking Road Tadworth Surrey KT20 7NS Telephone:01304 616161

Date Feldene Gel leaflet last revised – October 2007

© Pfizer Limited

Ref (UK): FE 6_3


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Sulfacetamide Topical



Dosage Form: suspension
SULFACETAMIDE SODIUM
TOPICAL SUSPENSION USP, 10%

Rx only

Sulfacetamide Topical Description

Each mL of Sulfacetamide Sodium Topical Suspension USP, 10% contains 100 mg of sulfacetamide sodium in a vehicle consisting of purified water, propylene glycol, lauramide DEA (and) diethanolamine, polyethylene glycol 400 monolaurate, hydroxyethyl cellulose, sodium chloride, sodium metabisulfite, methylparaben, xanthan gum, EDTA and simethicone. Sulfacetamide sodium is a sulfonamide with antibacterial activity. Chemically sulfacetamide sodium is N' -[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:

Sulfacetamide Topical - Clinical Pharmacology

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, based on sulfonamides acting as a competitive inhibitor of para-aminobenzoic acid (PABA) utilization, an essential component for bacterial growth. While absorption through intact skin in humans has not been determined, in vitro studies with human cadaver skin indicated a percutaneous absorption of about 4%. Sulfacetamide sodium is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine largely unchanged. The biological half-life has been reported to be between 7 to 13 hours.

Indications and Usage for Sulfacetamide Topical

Sulfacetamide Sodium Topical Suspension USP, 10% is indicated in the topical treatment of acne vulgaris.

Contraindications

Sulfacetamide Sodium Topical Suspension USP, 10% is contraindicated for use by patients having a known hypersensitivity to sulfonamides or any other component of this preparation (see WARNINGS section).

Warnings

Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other reactions, discontinue use of this preparation (see ADVERSE REACTIONS section).

Sulfacetamide Sodium Topical Suspension USP, 10% contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than non-asthmatic people (see CONTRAINDICATIONS section).

Precautions

General: For external use only. Keep away from eyes. If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. Hypersensitivity reactions may occur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur. Sulfacetamide sodium can cause reddening and scaling of the skin. Particular caution should be employed if areas of involved skin to be treated are denuded or abraded.

Keep out of reach of children.

Carcinogenesis, Mutagenesis and Impairment of Fertility: Long term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy- Category C: Animal reproduction studies have not been conducted with Sulfacetamide Sodium Topical Suspension USP, 10%. It is also not known whether Sulfacetamide Sodium Topical Suspension USP, 10% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide Sodium Topical Suspension USP, 10% should be given to a pregnant woman only if clearly needed.

Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamide. There are no adequate and well controlled studies of Sulfacetamide Sodium Topical Suspension USP, 10% in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman.

Nursing Mothers: It is not known whether sulfacetamide sodium is excreted in the human milk following topical use of Sulfacetamide Sodium Topical Suspension USP, 10%. Systemically administered sulfonamides are capable of producing kernicterus in the infants of lactating women. Small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. Because many drugs are excreted in human milk, caution should be exercised in prescribing for nursing mothers.

Pediatric Use: Safety and effectiveness in pediatric patients under the age of 12 have not been established.

Adverse Reactions

In controlled clinical trials for the management of acne vulgaris, the occurrence of adverse reactions associated with the use of Sulfacetamide Sodium Topical Suspension USP, 10% was infrequent and restricted to local events. The total incidence of adverse reactions reported in these studies was less than 2%. Only one of 105 patients treated with Sulfacetamide Sodium Topical Suspension USP, 10% had local adverse reactions of erythema, itching and edema. It has been reported that sulfacetamide sodium may cause local irritation, stinging and burning. While the irritation may be transient, occasionally, the use of the medication has to be discontinued.

Sulfacetamide Topical Dosage and Administration

Apply a thin film to affected areas twice daily.

How is Sulfacetamide Topical Supplied

Sulfacetamide Sodium Topical Suspension USP, 10%, is supplied in

    118 mL bottles    NDC 0168-0382-04

Store at controlled room temperature 20°-25°C (68°-77°F) [see USP].

Shake well before using. Keep tightly closed.

E. FOUGERA & CO.
A division of Nycomed US Inc.
MELVILLE, NEW YORK 11747

I2382A
R11/07
#280

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 118 mL (4 fl oz) CONTAINER LABEL

NDC 0168-0382-04

FOUGERA ®

SULFACETAMIDE

SODIUM TOPICAL

SUSPENSION USP, 10%

USUAL DOSAGE: Shake well before using. Apply a thin film to the affected areas twice daily. See package insert for full prescribing information.

WARNING: Keep away from eyes. For external use only. Keep out of reach of children.

Store at Controlled Room Temperature 20°-25°C (68°-77°F) [see USP]. Keep tightly closed.

Each mL of Sulfacetamide Sodium Topical Suspension USP, 10% contains 100 mg of sulfacetamide sodium in a vehicle consisting of purified water, propylene glycol, lauramide DEA (and) diethanolamine, polyethylene glycol 400 monolaurate, hydroxyethyl cellulose, sodium chloride, sodium metabisulfite, methylparaben, xanthan gum, EDTA and simethicone.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 118 mL (4 fl oz) CARTON

NDC 0168-0382-04

FOUGERA ®

SULFACETAMIDE

SODIUM TOPICAL

SUSPENSION

USP, 10%

Rx only

118 mL (4 fl oz)

E. FOUGERA & CO.

A division of Nycomed US Inc.

Melville, New York 11747


SULFACETAMIDE SODIUM 
sulfacetamide sodium  suspension Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0168-0382 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sulfacetamide sodium (sulfacetamide) sulfacetamide sodium 100 mg  in 1 mL Inactive Ingredients Ingredient Name Strength water   sodium chloride   sodium metabisulfite   edetate disodium   xanthan gum   propylene glycol   methylparaben   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0168-0382-04 118 mL In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077015 08/28/2008
Labeler - E. FOUGERA & CO., A division of Nycomed US Inc. (043838424) Registrant - Nycomed US Inc. (043838424) Establishment Name Address ID/FEI Operations Nycomed US Inc. 174491316 MANUFACTURE Establishment Name Address ID/FEI Operations Nycomed US Inc. 043838424 ANALYSIS Revised: 09/2009E. FOUGERA & CO., A division of Nycomed US Inc. More Sulfacetamide Topical resources Sulfacetamide Topical Use in Pregnancy & Breastfeeding Sulfacetamide Topical Support Group 0 Reviews for Sulfacetamide Topical - Add your own review/rating Compare Sulfacetamide Topical with other medications Seborrheic Dermatitis Secondary Cutaneous Bacterial Infections
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Urea Solution



Urea Topical Suspension 50%
in a lactic acid & salicylic acid vehicle

For external use only. Not for ophthalmic use. Do not use on eyes, lips or mucous membranes.

DESCRIPTION: Each gram of Urea Topical Suspension 50% contains urea 50% caprylic/capric triglyceride carbomer, cetyl alcohol, edetate disodium, glycerin, hydroxyethylcellulose, lactic acid, linoleic acid, PEG-6, polysorbate 60, propylene glycol, purified water, salicylic acid, sorbitan stearate, titanium dioxide, trolamine, vitamin E and xanthan gum.

UREA is a diamide of carbonic acid with the following chemical structure:

CLINICAL PHARMACOLOGY: Urea gently dissolves the intercellular matrix, which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, which then softens the hyperkeratotic areas.

PHARMACOKINETICS: The mechanism of action of topically applied urea is not yet known.

INDICATIONS AND USES: For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses, as well as damaged, devitalized, and ingrown nails.

CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients.

WARNINGS: For external use only. Avoid contact with eyes, lips or mucous membranes.

PRECAUTIONS: This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.

PREGNANCY: Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus; however, there are no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response. Urea Topical Suspension 50% should be given to pregnant women only if clearly needed.

NURSING MOTHERS: It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Urea Topical Suspension 50% is administered to nursing women.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication.

Call your doctor for medical advice about side effects.

DOSAGE AND ADMINISTRATION: Apply Urea Topical Suspension 50% to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed.

HOW SUPPLIED: Urea Topical Suspension 50%, NDC # 42808-0201-10, is supplied in a 10 oz (283.5 g) tube.

STORAGE: Store at controlled room temperature 15 to 30°C (59 to 86°F).

Protect from freezing.

Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

00-0201-10-205-00

Iss:5/11

PRINCIPAL DISPLAY PANEL - 10 oz (284 g)

For External Use Only

NDC 42808-0201-10        Rx Only

Urea
In a lactic acid & salicylic acid vehicle

50%

SUSPENSION

Exact-Rx.
INCORPORATED

Net Wt. 10 oz (284 g)


UREA 
urea  suspension Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 42808-201 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UREA) UREA 500 mg  in 1 g Inactive Ingredients Ingredient Name Strength CAPRYLIC/CAPRIC MONO/DIGLYCERIDES   CARBOMER HOMOPOLYMER TYPE C   CETYL ALCOHOL   EDETATE DISODIUM   GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   LACTIC ACID   LINOLEIC ACID   PEG-6 STEARATE   POLYSORBATE 60   PROPYLENE GLYCOL   WATER   SALICYLIC ACID   SORBITAN MONOSTEARATE   TITANIUM DIOXIDE   TROLAMINE   ALPHA-TOCOPHEROL   XANTHAN GUM   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 42808-201-10 1 TUBE In 1 CARTON contains a TUBE 1 284 g In 1 TUBE This package is contained within the CARTON (42808-201-10)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 08/01/2011
Labeler - Exact-Rx, Inc. (137953498) Revised: 08/2011Exact-Rx, Inc.
More Urea Solution resources Urea Solution Use in Pregnancy & Breastfeeding Urea Solution Support Group 9 Reviews for Urea - Add your own review/rating Compare Urea Solution with other medications Dermatological Disorders Dry Skin Pityriasis rubra pilaris
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Cetirizine Drug Facts



Dosage Form: tablet, chewable
Drug Facts Active ingredient

(in each chewable tablet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose sneezing itchy, watery eyes itching of the nose or throat Warnings

Do not use if you have ever had an allergic reactions to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product

drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

if breast-feeding: not recommended if pregnant: ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions may be taken with or without water adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information Store between 20 to 25 C (68 to 77 F) Inactive ingredients

acesulfame potassium, artificial flavors, benzyl alcohol, betadex, colloidal silicon dioxide, dl-alpha-tocopherol, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, talc and tutti frutti flavor

 

Questions? 1-800-525-8747

Manufactured in India by Sandoz Private Ltd.,

for Sandoz Inc., Princeton, NJ 08540

Rev.02/2008

Principal Display Panel

 

NDC 0781-5284-64

Children's

Cetirizine HCl Chewable Tablets

10 mg

antihistamine

Tutti Frutti Flavored

30 Tablets

Do not use if individual blister unit is open or torn

ALLERGY

Indoor & Outdoor Allergies

24 hour Relief of

Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose

6 yrs. and older 10 mg each


CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride  tablet, chewable Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0781-5284 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM   BENZYL ALCOHOL   BETADEX   COLLOIDAL SILICON DIOXIDE   ALPHA-TOCOPHEROL, DL-   FERRIC OXIDE RED   FERRIC OXIDE YELLOW   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   MALTODEXTRIN   CELLULOSE, MICROCRYSTALLINE   PROPYLENE GLYCOL   TALC   Product Characteristics Color YELLOW (peach, mottled) Score no score Shape ROUND Size 9mm Flavor Imprint Code SZ;106 Contains          Packaging # NDC Package Description Multilevel Packaging 1 0781-5284-64 30 TABLET In 1 BOX, UNIT-DOSE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078692 02/14/2008
Labeler - Sandoz Inc (110342024) Revised: 09/2009Sandoz Inc
More Cetirizine Drug Facts resources Cetirizine Drug Facts Side Effects (in more detail) Cetirizine Drug Facts Dosage Cetirizine Drug Facts Use in Pregnancy & Breastfeeding Drug Images Cetirizine Drug Facts Drug Interactions Cetirizine Drug Facts Support Group 73 Reviews for Cetirizine Drug Facts - Add your own review/rating Compare Cetirizine Drug Facts with other medications Hay Fever Urticaria
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Elocon Scalp Lotion


1. Name Of The Medicinal Product

Elocon Scalp Lotion

2. Qualitative And Quantitative Composition

Mometasone Furoate 0.1% w/w

Propylene glycol 30.0% w/w

3. Pharmaceutical Form

Lotion

4. Clinical Particulars 4.1 Therapeutic Indications

Elocon Scalp Lotion is indicated for the treatment of inflammatory and pruritic manifestations of psoriasis and seborrhoeic dermatitis of the scalp.

4.2 Posology And Method Of Administration

Adults, including elderly patients and Children: A few drops of Elocon Scalp Lotion should be applied to affected scalp sites, once daily; massage gently and thoroughly until the medication disappears.

Use of topical corticosteroids in children should be limited to the least amount compatible with an effective therapeutic regimen and duration of treatment should be no more than 5 days.

4.3 Contraindications

Elocon Scalp Lotion is contraindicated in bacterial (e.g. impetigo), viral (e.g. herpes simplex, herpes zoster and chickenpox) and fungal (e.g. candida or dermatophyte) infections of the scalp. Elocon Scalp Lotion should not be used in patients who are sensitive to mometasone furoate or to other corticosteroids.

4.4 Special Warnings And Precautions For Use

If irritation or sensitisation develop with the use of Elocon, treatment should be withdrawn and appropriate therapy instituted.

Should an infection develop, use of an appropriate antifungal or antibacterial agent should be instituted. If a favourable response does not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled.

Local and systemic toxicity is common especially following long continued use on large areas of damaged skin. If used in childhood, courses should be limited to 5 days. Long term continuous therapy should be avoided in all patients irrespective of age.

Topical steroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of centralised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient supervision is important.

ELOCON Scalp Lotion contains propylene glycol which may cause skin irritation.

Care must be taken to keep the preparation away from the eyes.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Elocon should be administered to nursing mothers only after careful consideration of the benefit/risk relationship.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Local adverse reactions occasionally reported with Elocon include paresthesia, folliculitis, burning, pruritis, tingling, stinging, application site reactions, allergic contact dermatitis, hypopigmentation, hypertrichosis, secondary infection, furunculosis, striae, acneiform reactions and signs of skin atrophy.

Local adverse reactions reported infrequently with topical dermatologic corticosteroids include: skin dryness, irritation, perioral dermatitis, maceration of the skin and miliaria.

Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Chronic corticosteroids therapy may interfere with the growth and development of children.

4.9 Overdose

Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal function resulting in secondary adrenal insufficiency which is usually reversible. In such cases appropriate symptomatic treatment is indicated.

The steroid content of each container is so low as to have little or no toxic effect in the unlikely event of accidental oral ingestion.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Mometasone furoate exhibits marked anti-inflammatory activity and marked anti-psoriatic activity in standard animal predictive models.

In the croton oil assay in mice, mometasone was equipotent to betamethasone valerate after single application and about 8 times as potent after five applications.

In guinea pigs, mometasone was approximately twice as potent as betamethasone valerate in reducing m.ovalis-induced epidermal acanthosis (i.e. anti-psoriatic activity) after 14 applications.

5.2 Pharmacokinetic Properties

Pharmacokinetic studies have indicated that systemic absorption following topical application of mometasone furoate 0.1% is minimal, approximately 0.4% of the applied dose in man, the majority of which is excreted within 72 hours following application. Characterisation of metabolites was not feasible owing to the small amounts present in plasma and excreta.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of this SmPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Isopropyl alcohol;

propylene glycol;

hydroxypropyl cellulose;

sodium phosphate monobasic dihydrate;

phosphoric acid;

purified water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

30ml white LDPE bottles with LDPE dropper and white HDPE cap.

6.6 Special Precautions For Disposal And Other Handling

Not applicable

7. Marketing Authorisation Holder

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UK

8. Marketing Authorisation Number(S)

PL 00025/0579

9. Date Of First Authorisation/Renewal Of The Authorisation

5 May 1992 / 3 December 2007

10. Date Of Revision Of The Text

22 December 2010

11 LEGAL CATEGORY

Prescription Only Medicine

© Merck Sharp & Dohme Limited 2011. All rights reserved.

EloconSL/UK/12-10/7


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La Prairie Cellular Radiance Emulsion


Generic Name: avobenzone, octinoxate, octisalate
Dosage Form: cream
Cellular Radiance Emulsion

Active Ingredients                        Purpose

Avobenzone 3.0%                        Sunscreen

Octinoxate 7.5%                          Sunscreen

Octisalate  5.0%                        Sunscreen

Warnings

-for external use only

-when using this product keep out of eyes

-rinse with water to remove

-stop use and ask a doctor if rash or irritation develops and lasts

-keep out of reach of children

-do not use on infants under 6 months of age

Uses

-helps prevent sunburn

-for skin that burns easily

-provides moderate protection against sunburn

-higher SPF gives more sunburn protection


Directions

-for external use only

-when using this product keep out of eyes

-rinse with water to remove

-stop use and ask doctor if rash or irritation develops and lasts

-keep out of reach of children

-do not use on infants under 6 months of age

Inactive Ingredients: Water (Aqua), C12-15 Alkyl Ethylhexanoate, Cetyl Alcohol, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Sea Water (Maris Aqua), Dimethicone, Behenyl Alcohol, Stearyl Alcohol, Butylene Glycol, Propylene Glycol, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Batyl Alcohol, Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Phytosterols, Silicornia Herbacea Extract, Niacinamide, Hydrolyzed Oat Protein, Alpinia Galang Leaf Extract, Quartz, Disodium Adenosine Triphosphate, Tocopherol, Carica Papaya (Papaya) Fruit Extract, Cholesteryl Nonanoate, Cimicifuga Racemosa Root Extract, Copper Gluconate, PEG-20 Phytosterol, Actinidia Polygama Fruit Extract, Acetyl Heptapeptide-Gold, Cholesteryl Oleate, Dimethylmethoxy Chromanyl Palmitate, Corallina Officinalis Extract, Carbomer, Cholsteryl Stearate, Acrylates Copolymer, Boswellia Serrata Extract, Ammonium Acryloyldimethltaurate/Beheneth-25 Methacrylate Crosspolymer, Phormidium Persicinum Extract, Caprylyl Glycol, Dextran, Magnesium Asparate Glyceryl Stearate, Disodium EDTA, Xanthan Gum, BHT, Fragrance (Parfum), Linalool, Hexyl Cinnamal, Hydroxycitronellal, Alpha-Isomethyl Ionone, Geraniol, Citronellol, Benzyl Benzoate, Butylphenyl Methylpropional, Evernia Furfuracea (Treemoss) Extract, Eugenol, Benzyl Salicylate, Limonene, Phenoxyethanol, Sorbia Acid, Methylparaben, Mica, Titanium Dioxide (CI 77891), Red (CI 14700), Yellow 5 (CI 19140), Gold

Cellular Radiance Emulsion

SPF 30

50 ml / 1.7 Fl. Oz.


LA PRAIRIE SWITZERLAND  CELLULAR RADIANCE EMULSION
avobenzone, octinoxate, octisalate  cream Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68807-301 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (AVOBENZONE) AVOBENZONE 3.0 kg  in 100 kg OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 kg  in 100 kg OCTISALATE (OCTISALATE) OCTISALATE 5.0 kg  in 100 kg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 68807-301-11 78.4 kg In 1 DRUM None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2009
Labeler - Temmentec Ag (480586411) Registrant - Temmentec Ag (480586411) Establishment Name Address ID/FEI Operations Temmentec Ag 480586411 manufacture Revised: 05/2010Temmentec Ag
More La Prairie Cellular Radiance Emulsion resources La Prairie Cellular Radiance Emulsion Side Effects (in more detail)La Prairie Cellular Radiance Emulsion Support Group0 Reviews · Be the first to review/rate this drug
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Keratol 45 Nail Gel


Generic Name: urea
Dosage Form: gel
Keratol 45 Nail Gel

DESCRIPTION: KeratolTM 45 Nail Gel, is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin.  Each gram of KeratolTM 45 Nail Gel contains 45% Urea, camphor, edetate disodium, eucalyptus oil, hydroxyethyl Cellulose, menthol, propylene glycol and purified water.

Urea is a diamide of carbonic acid with the following chemical structure:

CLINICAL PHARMACOLOGY:  Urea gently dissolves the intercellular matrix, which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas.  Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.

PHARMACOKINETICS: The mechanism of action of topically applied Urea is not yet known.

INDICATIONS AND USES: For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly when healing is retarded by local infection, necrotic tissue, fubrinous or purulent debris or eschar.  Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses, as well as damaged, devitalized and ingrown nails.

CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients.

PRECAUTIONS: This medication is to be used as directed by a physician and should not be used to treat any condition other than for which it was prescribed.  If redness or irritation occurs, discontinue use.

PREGNANCY: Pregnancy Category B.  Animal reproduction studies have revealed no evidence of harm to the fetus, however, there a no adequate and well-controlled studies in pregnant women.  Because animal reproductive studies are not always predictive of human response, KeratolTM 45 Nail Gel should be given to a pregnant women only if clearly needed.

If pregnant, or planning to become pregnant or currently breast-feeding please contact your physician, or health-care provider before using or continuing use.

NURSING MOTHERS: It is not known whether or not this drug is secreted in human milk.  Because many drugs are secreted in human milk, caution should be exercised when KeratolTM 45 Nail Gel is administered to a nursing mother.

WARNING:  KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.  IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.

DOSAGE AND ADMINISTRATION: DIRECTIONS FOR NAILS:  Apply KeratolTM 45 Nail Gel to diseased or damaged nail tissue twice per day, or as directed by a physician.

DIRECTIONS FOR SKIN: Apply KeratolTM 45 Nail Gel to affected area(s)  twice per day, or as directed by a physician.  Rub in until gel is absorbed.

HOW SUPPLIED:

KeratolTM 45 Nail Gel

28 mL bottle, NDC 51991-701-41

Store at 25°C (77°F); excursion permitted to 15°-30°C (59°-86°F).  See USP Controlled Room Temperature.

Protect from freezing.

Dispense in original container.

All prescription substitutions using this product shall be pursuant to state statutes as applicable.  This is not an Orange Book product.

Distributed by:

Breckenridge Pharmaceutical, Inc.

Boca Raton, FL 33487



Manufactured by:

Groupe PARIMA, Inc.

Montreal, QC H4S 1X6 CANADA





KERATOL 45  NAIL
urea  gel Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51991-701 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UREA) UREA 450 mg  in 1 g Inactive Ingredients Ingredient Name Strength CAMPHOR   EDETATE DISODIUM   EUCALYPTUS OIL   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   LEVOMENTHOL   PROPYLENE GLYCOL   WATER   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 51991-701-41 1 BOTTLE In 1 CARTON contains a BOTTLE, GLASS 1 28 g In 1 BOTTLE, GLASS This package is contained within the CARTON (51991-701-41)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/25/2010
Labeler - Breckenridge Pharmaceutical Inc. (150554335) Registrant - Groupe Parima Inc. (252437850) Establishment Name Address ID/FEI Operations Groupe Parima Inc. 252437850 manufacture Revised: 01/2010Breckenridge Pharmaceutical Inc.
More Keratol 45 Nail Gel resources Keratol 45 Nail Gel Use in Pregnancy & Breastfeeding 0 Reviews for Keratol 45 Nail - Add your own review/rating Compare Keratol 45 Nail Gel with other medications Dermatological Disorders Dry Skin Pityriasis rubra pilaris
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Hydroquinone


Class: Depigmenting Agents
ATC Class: D11AX11
VA Class: DE900
Chemical Name: 1,4 p-dihydroxybenzene
Molecular Formula: C6H6O2
CAS Number: 123-31-9
Brands: Aclaro PD, Alphaquin HP, Claripel, Eldopaque Forte, Eldoquin Forte, EpiQuin Micro, Esoterica, Esoterica Regular, Glyquin XM, Lustra, Lustra-Ultra, Melquin, Melpaque HP, Melquin, Nuquin HP, Solaquin, Tri-Luma

Introduction

Depigmenting agent; structurally related to monobenzone.a h s

Uses for Hydroquinone Hyperpigmentation

Used to reduce hyperpigmentation in conditions such as freckling (ephelides), inactive chloasma, melasma, generalized and senile lentigo, and other unwanted areas of melanin hyperpigmentation.a b m

Used for gradual treatment of ultraviolet-induced dyschromia and skin discoloration resulting from the use of oral contraceptives, pregnancy, hormone replacement therapy, or skin trauma.p s

Most clinicians consider hydroquinone to be useful in some patients with hyperpigmentation in which a large excess of melanin is not being produced.a

Has been used to reduce hyperpigmentation caused by photosensitization associated with inflammation or with the use of certain perfumes.a

Used in combination with fluocinolone and tretinoin for short-term and intermittent long-term treatment of moderate to severe melasma.q

Hydroquinone Dosage and Administration General

Depigmentation varies among patients in completeness, time of onset, and duration; rarely completely reduces hyperpigmentation and some patients exhibit no response to the drug.a

May require 1–4 months for depigmentation effects to occur.a Following discontinuance of hydroquinone, depigmentation effects usually persist for 2–6 months.a

Avoid unnecessary exposure to sunlight during and after therapy.a b h p s

Prior to initiating therapy, assess the risk of irritation or allergic reactions by applying a small amount of hydroquinone preparation to an area of unbroken skin.a b h m p s After 24 hours, examine test site; discontinue treatment if itching, vesicle formation, or excessive inflammation occurs; however, minor redness is not a contraindication for further treatment.a b h p s

Administration Topical Administration

Apply topically to the skin as a cream, gel, emulsion, or solution.a b m p q s (See Sensitivity Reactions under Cautions.)

Limit application to an area equal to that of the face and neck or hands and arms.a s

For dermatologic use only; avoid contact with eyes.a b q s If such contact occurs, flush the affected eye(s) with copious amounts of water and contact a clinician.b

Not for oral administration.a

Apply hydroquinone cream, gel, emulsion, or solution (with or without sunscreens) uniformly to pigmented area and rub into skin.a b p s Do not rub cream containing opaque sunblocking agents (e.g., talc) into the skin.b h

If hydroquinone preparations without sunscreen agents are applied during the daytime, use sunscreen agents and/or protective clothing to minimize exposure and prevent repigmentation of treated areas; alternatively, apply these preparations only at night.a b h p q

Gently wash face and neck with mild soap, rinse, and pat dry before applying fixed-combination hydroquinone, fluocinolone, and tretinoin cream to affected area(s).q

Apply a small amount of fixed-combination hydroquinone, fluocinolone, and tretinoin cream to affected area(s), including about ? inch of normal skin surrounding each lesion.q Rub lightly and uniformly into the skin.q Do not use occlusive dressing.q

Dosage

When the desired degree of depigmentation is obtained, apply only as often as needed to maintain depigmentation.a

Pediatric Patients Hyperpigmentation Topical

Adolescents >12 years of age: Apply hydroquinone cream, emulsion, gel, or solution (with or without sunscreens) uniformly to pigmented area(s) and rub in well twice daily, in the morning and evening.a b p s

If improvement does not occur after 2 months of treatment, discontinue the drug.b p s

Adults Hyperpigmentation Topical

Hydroquinone cream, emulsion, gel, or solution (with or without sunscreens): Apply uniformly to pigmented area(s) and rub in well twice daily, in the morning and evening or as directed by a clinician.a b h p s

Hydroquinone cream with opaque sunblock: Apply uniformly to the pigmented area(s) twice daily, in the morning and evening; do not rub into affected area(s).b h

If improvement does not occur after 2 months of treatment, discontinue the drug.b p

Melasma Topical

Fixed-combination hydroquinone, fluocinolone, and tretinoin cream: Apply a thin layer uniformly to the affected area(s) once daily, in the evening, at least 30 minutes before bedtime.q Continue daily for as long as the melasma lesions persist.q Discontinue treatment when melasma resolves.q

If melasma reoccurs, repeat treatment until condition resolves.q

Prescribing Limits Pediatric Patients Hyperpigmentation Topical

Adolescents >12 years of age: Maximum 2 months of therapy if no improvement is seen.b

Adults Hyperpigmentation Topical

Maximum 2 months of therapy if no improvement is seen.b p s

Melasma Topical

Fixed-combination hydroquinone, fluocinolone, and tretinoin cream has been safely administered for cumulative ?180 days.q

Special Populations Geriatric Patients

Clinical studies of 4% hydroquinone cream did not include sufficient number of patients ?65 years of age to determine whether they respond differently from younger patients. In general, dosage selection for geriatric patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy.

Cautions for Hydroquinone Contraindications

History of sensitivity or allergic reaction to hydroquinone or any ingredient in the formulation.a b p q s

Warnings/Precautions Warnings Cosmetic Effects

May produce undesired cosmetic effects (e.g., excessive skin bleaching)q if not used as directed.a b p s Clinician should be familiar with the use, adverse effects, precautions, and contraindications before prescribing or dispensing the drug.a p s

Exposure to Sunlight or Ultraviolet Light

Exposure to sunlight or ultraviolet light may cause repigmentation of bleached areas.a b h p q Avoid unnecessary exposure to sunlight during and after therapy.a b h p s

Sunscreen agents and/or protective clothing recommended if preparations which do not contain sunscreen are applied during the daytime.a b h p q s Preparations containing sunscreen may provide sufficient protection from sunlight.a b h

After reduction of hyperpigmentation and during maintenance therapy, continue the use of sunscreen agents and/or protective clothing.a b h

Sensitivity Reactions Sulfite Sensitivity

Some formulations contain sulfites, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.y z aa bb cc dd ee ff

Other Sensitivity Reactions

Contact dermatitis reported.b h p q s If contact dermatitis occurs, discontinue immediately and contact a clinician.p q s

Major Toxicities

Rarely, ochronosis (gradual blue-black darkening of the skin) and colloid milium reported with chronic use (up to 8 years) of 5% hydroquinone cream. a o p q If affected skin changes to a blue-black color, discontinue immediately and contact a clinician.p q

General Precautions Topical Use

For external use only.b Notfor topical application in the eyes, ears, or mouth;a b p to cut, abraded,m or sunburned skin; after shaving or using a depilatory agent; or over miliaria rubra (prickly heat).a

Dermatologic Effects

Possible local skin irritation (e.g., burning, stinging, mild erythema).a h Dryness and fissuring of paranasal and infraorbital areas reported.a b

Use of Fixed Combinations

When hydroquinone is used in fixed combination with topical sunscreens (e.g., dioxybenzone, oxybenzone, and padimate), fluocinolone, or retinoids (e.g., tretinoin), consider the cautions, precautions, and contraindications associated with these agents.b h p q

Specific Populations Pregnancy

Category C.b

Lactation

Not known if topical hydroquinone is distributed into milk.a b Caution advised if topical hydroquinone is used.a b

Pediatric Use

Safety and efficacy of hydroquinone preparations not established in children <12 years of age.a b

Safety and efficacy of the fixed-combination hydroquinone, fluocinolone, and tretinoin cream not established in pediatric patients of any age.q

Common Adverse Effects

Mild skin irritation and sensitization (e.g., burning, erythema, stinging).a h

Hydroquinone Pharmacokinetics Absorption Duration

Depigmentation effects usually persist for 2–6 months following discontinuance of therapy.a

Stability Storage Topical

Manufacturer states that a slight darkening of hydroquinone preparation(s) is normal and will not affect potency.b

Cream, Gel, Emulsion, or Solution

Tight, light-resistant containersa b at 25°C (may be exposed to 15–30°C).h p s

Combination (Hydroquinone 4%, Fluocinolone acetonide 0.01%, and Tretinoin 0.05%) Cream

Tight, light-resistant containers at 20–25°C.q Do not freeze.q

ActionsActions

May produce a reversible skin depigmentation by inhibiting the enzymatic oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (DOPA) and suppressing other melanocyte metabolic processes.b p q s

Increases the excretion of new melanin while existing melanin is lost during the normal sloughing of the stratum corneum.a

May prevent melanin production; however, does not cause destruction of melanocytes or permanent depigmentation.a

Advice to Patients

Importance of advising patients that topical hydroquinone is a bleaching agent and should not be used for the prevention of sunburn.a

Importance of avoiding contact with eyes.a b s If ocular contact occurs, rinse eye(s) promptly and thoroughly with water.b

Importance of advising patients that a bitter taste and an antiseptic effect may occur if hydroquinone is applied to lips.b

Importance of keeping hydroquinone preparations out of the reach of children.b h p

Importance of using sunscreen products (SPF ?15)p and wearing protective clothing over treated areas.a b h q s Avoid exposure to sunlight, sunlamp, or ultraviolet light during and after treatment.p q

Importance of discontinuing drug and informing clinician if an allergic or hypersensitivity (e.g., contact dermatitis) reaction occurs.b h m q

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.b q s

Importance of patients informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.m q

Importance of informing patients of other important precautionary information.q (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Hydroquinone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder*

Topical

Cream

2%

Esoterica Regular (with parabens, propylene glycol, and sodium bisulfite)

Medicis

4%

Aclaro PD (with benzyl alcohol and propylene glycol)

Johnson & Johnson

Eldopaque Forte (with propylene glycol and sodium metabisulfite in an opaque base)

Valeant

Eldoquin Forte (with propylene glycol, propylparaben, and sodium metabisulfite)

Valeant

EpiQuin Micro (with benzyl alcohol, methylparaben, retinol 0.15%, and sodium metabisulfite in a polymeric system)

SkinMedica

Hydroquinone Cream (with parabens, propylene glycol, and sodium metabisulfite)

Ethex

Lustra (with benzyl alcohol and sodium metabisulfite)

Taro

Lustra-Ultra (with parabens, propylene glycol, retinol 0.3%, and sodium metabisulfite)

Taro

Melpaque HP (with parabens, propylene glycol, and sodium metabisulfite in an opaque talc base)

Stratus

Melquin HP (with propylene glycol and sodium metabisulfite)

Stratus

Solution

3%

Melquin-3 (with SD alcohol 45%, isopropyl alcohol 4%, and propylene glycol)

Stratus

Hydroquinone Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

2% with Benzophenone-3 2.5% and Octyl Dimethyl 3.3%

Esoterica Daytime with Moisturizer (with parabens, propylene glycol, and sodium bisulfite)

Medicis

Esoterica Daytime Sunscreen (with parabens, propylene glycol, and sodium bisulfite)

Medicis

Esoterica Nighttime with Moisturizer (with parabens, propylene glycol, and sodium bisulfite)

Medicis

4% with Avobenzone 3% and Octinoxate 7.5%

Claripel Cream with Sunscreens (with parabens, propylene glycol, and sodium metabisulfite)

Stiefel

4% with Avobenzone 3%, Oxybenzone 4%, and Octocrylene 8%

Glyquin XM (with methylparaben and propylene glycol)

Valeant

4% with Benzophenone-3 5% and Octyl Methoxycinnamate 7.5%

Alphaquin HP (with propylene glycol and sodium metabisulfite)

Stratus

4% with Dioxybenzone 3%, Oxybenzone 2%, and Padimate O 8%

Hydroquinone Cream with Sunscreens (with parabens, propylene glycol, and sodium metabisulfite)

Ethex

Hydroquinone Cream with Sunscreens (with propylene glycol and sodium metabisulfite)

Perrigo

Nuquin HP (with propylene glycol and sodium metabisulfite)

Stratus

Solaquin Forte (with propylene glycol and sodium metabisulfite)

Valeant

4% with Fluocinolone Acetonide 0.01% and Tretinoin 0.05%

Tri-Luma (with sodium metabisulfite)

Galderma

Gel

4% with Dioxybenzone 3% and Padimate O 5%

Hydroquinone Forte Gel (with propylene glycol and sodium metabisulfite)

Perrigo

Nuquin HP (with alcohol, propylene glycol, and sodium metabisulfite)

Stratus

Solaquin Forte (with propylene glycol and sodium metabisulfite)

Valeant

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. AHFS Drug Information 2007. McEvoy GK, ed. Hydroquinone. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 3551-2.

b. Stratus Pharmaceuticals. Alphaquin HP (hydroquinone 4%) cream product information. Miami, FL. 2007

h. ICN Pharmaceuticals. Eldoquin Forte (hydroquinone 4%) cream, Eldopaque Forte(hydroquinone 4% with sun block) cream, Solaquin Forte (hydroquinone 4% with sunscreens, SPF 17) cream and Solaquin Forte (hydroquinone 4% with sunscreens) gel product information. Costa Mesa, CA;1998 Sept.

m. Medicis. Esoterica (hydroquinone USP, 2%) cream product information. Phoenix, AZ.

o. Food and Drug Administration. Skin Bleaching Drug Products For Over-the-Counter Human Use. Proposed Rule. [21 CFR Part 310] Fed Regist. 2006. 71:167: 51146-54.

p. SkinMedica. EpiQuin Micro (hydroquinone 4% and retinol) skin bleaching moisturizing topical cream prescribing information. 2003 Sept.

q. Galderma Laboratories. TRI-LUMA(fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) cream prescribing information. Fort Worth, TX; 2003 Dec.

s. JSJ Pharmaceuticals. Aclaro PD (hydroquinone 4%) bioadhesive emulsion product information. Charleston, SC; 2007 Jan.

t. JSJ Pharmaceuticals. Charleston, SC: Personal communication.

y. Food and Drug Administration. Sulfites in foods and drugs. FDA Drug Bull. 1983; 13:12. [PubMed 6604672]

z. Sogn D. The ubiquitous sulfites. JAMA. 1984; 251:2986 7. Editorial. [IDIS 185969] [PubMed 6716628]

aa. Koepke JW, Christopher KL, Chai H et al. Dose dependent bronchospasm from sulfites in isoetharine. JAMA. 1984; 251:2982 3. [IDIS 185966] [PubMed 6716626]

bb. Twarog FJ, Leung DYM. Anaphylaxis to a component of isoetharine (sodium bisulfite). JAMA. 1982; 248:2030 1. [IDIS 158261] [PubMed 7120631]

cc. Baker GJ, Collett P, Allen DH. Bronchospasm induced by metabisulphite containing foods and drugs. Med J Aust. 1981; 2:614 7. [IDIS 146240] [PubMed 7334982]

dd. Koepke JW, Selner JC, Dunhill AL. Presence of sulfur dioxide in commonly used bronchodilator solutions. J Allergy Clin Immunol. 1983; 72:504 8. [IDIS 178793] [PubMed 6630799]

ee. Food and Drug Administration. Sulfiting agents; labeling in drugs for human use: warning statement. [Docket No. 84N 0113] Fed Regist. 1985; 50:47558 63.

ff. Food and Drug Administration Center for Food Safety and Applied Nutrition. The reexamination of the GRAS status of sulfiting agents, January 1985. (Doc. No. 223-83-2020.) Bethesda, MD: FASEB Life Sciences Research Office.

More Hydroquinone resources Hydroquinone Side Effects (in more detail) Hydroquinone Use in Pregnancy & Breastfeeding Hydroquinone Support Group 2 Reviews for Hydroquinone - Add your own review/rating Aclaro Concise Consumer Information (Cerner Multum) Alustra MedFacts Consumer Leaflet (Wolters Kluwer) Epiquin Micro Prescribing Information (FDA) Esoterica Cream MedFacts Consumer Leaflet (Wolters Kluwer) Solaquin Forte Cream MedFacts Consumer Leaflet (Wolters Kluwer) Compare Hydroquinone with other medications Dermatological Disorders
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Ibuderm


Information for the user

IBUDERM

GEL ibufropen 5% w/w

Read all of this leaflet carefully before using this product.

This medicine is available without prescription. However, you still need to use it carefully to get the best results from it. Keep this leaflet. You may need to read it again.

Ask your doctor or pharmacist if you need more information or advice.

You must contact a doctor if your symptoms worsen or do not improve after a few weeks.

If any of the side effects get serious or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.

In this leaflet: 1. What Ibuderm Gel is and what it is used for 2. Before you use Ibuderm Gel 3. How to use Ibuderm Gel 4. Possible side effects 5. How to store Ibuderm Gel 6. Further information What Ibuderm Gel Is And What It Is Used For Ibuderm Gel is an anti-inflammatory painkiller applied to, and absorbed through, the skin. It is for the treatment of the following conditions involving the musculoskeletal system: muscular backache muscular pain rheumatic pain aches pains swellings sprains strains sports injuries. Ibuderm Gel is recommended for use by adults, the elderly and children over the age of 12 years. Children under the age of 12 may also use it if recommended by their doctor. The active ingredient in this product is ibuprofen. This is one of a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Ibuprofen works by: relieving pain reducing swelling and inflammation. Before You Use Ibuderm Gel Do not use Ibuderm Gel: if you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of Ibuderm Gel listed in section 6; if you are asthmatic, or suffer from rhinitis (allergic runny nose) or urticaria (hives) and have ever had a bad reaction to aspirin, ibuprofen or other NSAIDs in the past; if you are pregnant or breast-feeding; on broken, damaged, infected or diseased skin. Before applying this product for the first time, make sure it is suitable for you to use:

Because Ibuderm Gel is delivered through the skin, directly over the painful area, there is less risk of the complications that sometimes occur when ibuprofen (or a similar anti-inflammatory painkiller) is taken by mouth. However, in rare cases you may be at risk:

if you have a stomach ulcer (also called a peptic or gastric ulcer); if you have ever had kidney problems; if you have ever had asthma; if you have ever had a bad reaction to aspirin or ibuprofen taken by mouth.

If any of the above apply to you, only use this product on advice from your doctor or pharmacist.

Take special care when using this product: Use it only on the skin. Do not use it on children under 12 years old unless advised by a doctor. Do not apply it to broken or irritated skin. Do not use under protective waterproof dressings. Do not use more than the recommended dose (see Section 3). Keep the gel away from the eyes, nose and mouth. Using other medicines Interaction between Ibuderm Gel and blood pressure lowering drugs and anticoagulants is possible, in theory, although very unlikely. If you would like more advice about this, speak to your doctor or pharmacist. If you are also taking aspirin or other NSAIDs by mouth, discuss this beforehand with your doctor or pharmacist because these may increase the risk of undesirable effects. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including other medicines obtained without prescription. Pregnancy and breast-feeding

You should not use Ibuderm Gel if you are pregnant or breast-feeding.

Driving and using machinery

Using this product is not known to affect your ability to drive or use machinery.

Important information about one of the ingredients of Ibuderm Gel

The product contains a small amount of propylene glycol. This ingredient may cause skin irritation in a small number of people who are intolerant to it. If your doctor has told you that you have an intolerance to propylene glycol, please talk to your doctor before using this product.

How To Use Ibuderm Gel Before using this tube of gel for the first time, open it as follows: Unscrew the cap, turn it upside down and then use the sharp point of the cap to pierce the membrane in the neck of the tube. To use the gel

(for adults, the elderly and children over 12 years old):

Use the gel up to three times a day, leaving 4 hours between applications. Lightly apply the gel to intact skin over the painful area. Apply 4 to 10 cm gel to thinly cover the affected area, then massage gently until absorbed. Do not apply more than 30 cm of gel in any 24 hour period. Wash hands after use, unless treating them. Carry on using the gel in this way until your condition gets better (you may find you need to use it for a few weeks, and your doctor may want you to continue using it for longer than this). If your symptoms worsen or continue for more than a few weeks, discuss this with your doctor before continuing treatment. If the gel comes into contact with broken skin or gets into the eyes, nose or mouth The product may cause irritation if it comes into contact with broken skin or gets into the eyes, nose or mouth. If this happens, rinse the affected areas with plenty of water. If rinsing one eye, take care to avoid washing product into the other eye. If irritation persists, tell your doctor or pharmacist. If the gel is accidentally swallowed Symptoms may include headache, vomiting, drowsiness and low blood pressure. If you experience any of these symptoms contact a doctor or hospital straight away. If you forget to use this product

Do not worry if you occasionally forget to use this product, just carry on using it when you remember.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Ibuderm Side Effects

Like all medicines, Ibuderm Gel can cause side effects, although not everybody gets them.

Occasionally, mild skin rashes, itching or irritation can sometimes occur at the site of application. If this is unacceptable, or persists, stop using the product and tell your doctor or pharmacist.

Very rarely, the following side effects can happen with ibuprofen, although these are extremely uncommon with products such as Ibuderm Gel that are applied to the skin.

If you experience any of the following, stop using Ibuderm Gel immediately and tell your doctor: Allergic reactions (particularly in people who have a history of asthma or allergic problems), such as: unexplained runny nose and watery eyes, or, in more serious cases asthma or aggravated asthma involving breathing difficulties, wheezing or chest tightness; generalised allergic skin reactions involving itch, swelling, inflammation, redness and perhaps blistering and light sensitivity; other more serious generalised allergic reactions possibly involving unexplained nausea and vomiting, swollen eyes, face or tongue, difficulty swallowing, dizziness or light-headedness. Unconsciousness could perhaps occur in the most serious cases. Kidney problems (particularly in people who have a history of kidney disease), such as: decreased urine volume; loss of appetite / weight loss; swelling to abdomen. Problems with the digestive system (particularly in people who have a history of stomach ulcers etc), such as: stomach pain heartburn / indigestion.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Ibuderm Gel Keep it out of the reach and sight of children. Always replace the cap tightly after use. Do not store the product above 25°C. Do not use after the expiry date shown on the fold of the tube and the carton.
The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Further Information About Ibuderm Gel What Ibuderm Gel contains:

The active ingredient is ibuprofen (5% w/w).

The other ingredients are industrial methylated spirit, carbomers, propylene glycol, diethylamine and purified water.

What Ibuderm Gel looks like and contents of the pack The product is a clear, colourless gel that contains no fragrance. The gel is available in tubes containing 40 g. The Marketing Authorisation holder is Diomed Developments Limited Tatmore Place Gosmore Hitchin Herts SG4 7QR UK The Manufacturer is DDD Limited 94 Rickmansworth Road Watford Herts WD18 7JJ UK The Distributor is DDD Limited 94 Rickmansworth Road Watford Herts WD18 7JJ UK

This leaflet was last approved in
May 2008.

To listen to or request a copy of this leaflet in Braille, large print or audio, please call free of charge: 0800 198 5000 (UK only).

Please be ready to give the following information: Ibuderm Gel 00173/0060.

This is a service provided by the Royal National Institute of Blind People (RNIB).

KD102T-3


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Gavilax


polyethylene glycol-3350
Dosage Form: powder, for solution
Gavilax (Polyethylene Glycol 3350, Powder for Oral Solution) DESCRIPTION

Drug Facts

Active Ingredient (in each dose)…………………     Purpose

Polyethylene Glycol 3350, 17 g (cap filled to line).......Laxative

Use

relieves occasional constipation (irregularity)

generally produces a bowel movement in 1 to 3 days

WARNINGS

Allergy alert: Do not use if you are allergic to polyethylene glycol

Do not use if you have kidney disease, except under the advice and supervision of a doctor

Ask a doctor before use if you have

nausea, vomiting or abdominal pain

a sudden change in bowel habits that lasts over 2 weeks

irritable bowel syndrome

Ask a doctor or pharmacist before use if you are taking a prescription drug

When using this product you may have loose, watery, more frequent stools

Stop use and ask a doctor if

you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition.

you get diarrhea

you need to use a laxative for longer than 1 week

side effects occur.

Drug Facts (continued)

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a POISON CONTROL CENTER right away.

Directions

do not take more than directed unless advised by your doctor

the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line.

adults and children 17 years of age and older:

fill to top of line in cap which is marked to indicate the correct dose (17 g)

stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink

use once a day

use no more than 7 days

children 16 years of age or under: ask a doctor

Other Information

store at 20° - 25°C (68°– 77°F)

tamper-evident: do not use if printed foil seal under cap is missing, open or broken

Inactive Ingredients           none

Questions or comments?

1-866-403-7592

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Gavilax 
polyethylene glycol-3350  powder, for solution Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 43386-312 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POLYETHYLENE GLYCOL 3350 17 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 43386-312-08 14 DOSE PACK In 1 BOTTLE None 2 43386-312-14 30 DOSE PACK In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091077 10/09/2009
Labeler - GAVIS Pharmaceuticals, LLC (829838551) Contact Address Telephone Number Email Address Anu Radha Subramanian Address: 400 Campus Drive City, State, Zip: Somerset, NJ, 08873 Country: USA ++1908-603-6080 ars@gavispharma.com Registrant - Novel Laboratories, Inc. (793518643) Establishment Name Address ID/FEI Operations Novel Laboratories, Inc. 793518643 manufacture, repack, MANUFACTURE, ANALYSIS, ANALYSIS Establishment Name Address ID/FEI Operations Dow Chemical Company 801038019 api manufacture, MANUFACTURE Revised: 10/2009GAVIS Pharmaceuticals, LLC
More Gavilax resources Gavilax Side Effects (in more detail) Gavilax Use in Pregnancy & Breastfeeding Gavilax Drug Interactions Gavilax Support Group 0 Reviews for Gavilax - Add your own review/rating GlycoLax Concise Consumer Information (Cerner Multum) GlycoLax Powder for Oral Solution MedFacts Consumer Leaflet (Wolters Kluwer) Compare Gavilax with other medications Bowel Preparation Constipation Constipation, Acute
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