Keratol 45 Cream

Generic Name: urea

Dosage Form: cream
Keratol 45 Cream

DESCRIPTION: KeratolTM 45 Cream is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin.  Each gram of KeratolTM 45 Cream contains 45% Urea, camphor, edetate disodium, eucalyptus oil, ethyl alcohol, hydroxyethyl cellulose, menthol, purified water and titanium dioxide.


Urea is a diamide of carbonic acid with 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.

PHARMOCOKINETICS: 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 reproductive studies are not always predictive of human response, KeratolTM 45 Cream should be given to a pregnant woman only if clearly needed.

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

NURSING MOTHER: 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 Cream is administered to a nursing woman.

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: Apply KeratolTM 45 Cream to affected skin twice per day, or as directed by a physician.  Apply to diseased or damaged nails twice per day, or as directed by a physician.

HOW SUPPLIED:

KeratolTM 45 Cream

9oz. tube, NDC 51991-702-58

Store at 25°C (77°F); excursions 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, FL33487

Manufactured by:

Groupe PARIMA, Inc.

Montreal, QC H4S 1X6  CANADA

KERATOL 45  CREAM urea  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51991-702 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   ALCOHOL   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   LEVOMENTHOL   WATER   TITANIUM DIOXIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51991-702-58 1 TUBE In 1 CARTON contains a TUBE 1 255 g In 1 TUBE This package is contained within the CARTON (51991-702-58)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/02/2010

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)

Registrant - Groupe parima, Inc. (252437850)

Establishment
Name	Address	ID/FEI	Operations
Groupe parima, Inc.		252437850	manufacture

Revised: 02/2010Breckenridge Pharmaceutical, Inc.

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