Kerol AD

urea emulsion

Dosage Form: emulsion
Kerol™ AD

(45% urea emulsion)

Accu-Dose

In a zinc undecylenate and lactic acid vehicle

For external use only. Not for ophthalmic use.

Rx only

DESCRIPTION

Each mL of KerolTM AD contains 45% urea in a formulation consisting of: propylene glycol, caprylic/capric triglycerides, polyethylene glycol 300, purified water, trolamine, vitamin E acetate, lactic acid, glycerin, polysorbate-60, linoleic acid, sorbitan monostearate, zinc undecylenate, titanium dioxide, cetyl alcohol, EDTA disodium, hydroxyethyl cellulose 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, thereby softening 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 pilaris, keratosis palmaris, keratoderma, corns and calluses.

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, KerolTM AD should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS

It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when KerolTM AD is administered to a nursing woman.

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

Adverse Reactions

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

DOSAGE AND ADMINISTRATION

Apply KerolTM AD to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed.

HOW SUPPLIED

KerolTM AD (45% urea emulsion) is supplied as:

240 mL bottle, NDC 10337-643-24

Store at 15˚-30˚ C (59˚- 86˚ F).

Protect from freezing.

Mfd. for:

PharmaDerm®

A division of Nycomed US Inc.

Melville, NY 11747 USA

www.pharmaderm.com

Mfd. by:

Pegasus Laboratories, Inc.

Pensacola, FL 32514

IF643

R5/09

How to use

Rx only

Kerol™ AD

(45% urea emulsion)

Accu-Dose

In a zinc undecylenate and lactic acid vehicle

Steps for using Kerol AD to treat dry skin conditions including psoriasis, xerosis, ichthyosis, keratosis pilaris, keratosis palmaris, keratoderma, dermatitis, pruritus, eczema, corns and calluses.

Kerol AD can be applied directly to the treatment area(s) without pouring from a bottle or squeezing from a tube. The pump is designed to consistently deliver a precise amount of Kerol AD with each use once the pump has been primed and medication is delivered to the spout. To begin using Kerol AD:

1. Remove the cap.


2. With the first use, prime the chamber by pushing the pump top all the way down and then release. Repeat this four to six times until the chamber inside is filled and the Kerol AD passes through the spout.*


3. To use after the chamber is filled, push the pump top all the way down to dispense one dose of Kerol AD. A precise amount of Kerol AD will be consistently delivered with each use.


4. Apply Kerol AD to the affected area(s).


5. Gently massage Kerol AD into the affected area twice a day or as directed by your physician. Keep Kerol AD away from the eyes, lips or mucous membranes.


6. Replace the cap.

* Sample bottles of Kerol AD have a different fill ratio and will need to be pumped eight to ten times to prime the chamber and get the Kerol AD to pass through the spout.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 240 mL CONTAINER LABEL

NDC 10337-643-24

PharmaDerm®

NDC 10337-643-24

Rx only

KEROL™ AD

(45% urea emulsion)

Accu-Dose

In a zinc undecylenate and lactic acid vehicle

For Topical Use Only

Net Content 240 mL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 240 mL CARTON

PharmaDerm®

NDC 10337-643-24

Rx only

KEROL™ AD

(45% urea emulsion)

Accu-Dose

In a zinc undecylenate and

lactic acid vehicle

For Topical

Use Only

Net Content 240 mL

Kerol AD  urea  emulsion

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 10337-643 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength urea (urea) urea 0.45 mL  in 1 mL

Inactive Ingredients Ingredient Name Strength propylene glycol   polyethylene glycol 300   water   trolamine   alpha-tocopherol acetate   lactic acid   glycerin   polysorbate 60   linoleic acid   sorbitan monostearate   zinc undecylenate   titanium dioxide   cetyl alcohol   edetate disodium   xanthan gum

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 10337-643-24 1 BOTTLE In 1 CARTON contains a BOTTLE 1 240 mL In 1 BOTTLE This package is contained within the CARTON (10337-643-24)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved other		09/15/2009

Labeler - PharmaDerm, A division of Nycomed US Inc. (043838424)

Registrant - Nycomed US Inc. (043838424)

Revised: 09/2009PharmaDerm, A division of Nycomed US Inc.

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