Keratol 45 Nail

KERATOL 45 NAIL — urea gel
Breckenridge Pharmaceutical Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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:

image of structure
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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


Image label
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Image carton
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KERATOL 45 NAIL
urea gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51991-701-41 1 BOTTLE, GLASS (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: 01/2010 Breckenridge Pharmaceutical Inc.

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