KERALAC NAILSTIK- urea solution
PharmaDerm a division of Fougera Pharmaceuticals 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.
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Keralac™
NAILSTIK (50% Urea) Doak
In a vehicle containing Lactic Acid and Zinc
DESCRIPTION:
Keralac™ NAILSTIK (50% Urea) is a keratolytic solution, which is gentle, yet potent, tissue softener for nails. Each mL of Keralac™ NAILSTIK contains 50% Urea, Disodium EDTA, Hydroxyethylcellulose, Lactic Acid, PEG-6, Propylene Glycol, Purified Water, Triethanolamine, Xanthan Gum and Zinc Pyrithione.
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.
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, as well as damaged, devitalized, and ingrown nails.
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, Keralac™ NAILSTIK should be given to a pregnant woman only if clearly needed.
ADVERSE REACTIONS:
Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.
DOSAGE AND ADMINISTARTION:
Apply Keralac™ NAILSTIK to diseased or damaged nail tissue twice per day, or as directed by a physician.
HOW SUPPLIED:
Keralac™ NAILSTIK
NDC 10337-648-10, is supplied in a carton containing 6 NAILSTIKS (14.4 mL).
Store at controlled room temperature 15°-30° C (59°-86° F).
Protect from freezing.
Manufactured for: DERM/arts® DIVISION
DOAK DERMATOLOGICS
A SUBSIDIARY OF BRADLEY PHARMACEUTICALS, INC.
383 Route 46 West • Fairfield, NJ 07004-2402 USA
1-800-405-DOAK • www.doakderm.com
Manufactured by:
Pegasus Laboratories, Inc.
Pensacola, FL 32514
Patent Pending
IL240-R2
Rev. 05/06
PATIENT INSTRUCTIONS
Rx ONLY
Keralac™
NAILSTIK (50% Urea) Doak
In a vehicle containing Lactic Acid and Zinc
HOW TO USE Keralac™ NAILSTIK:
- Remove cap and twist dial at the bottom of the Keralac™ NAILSTIK until a small amount of solution appears on the sponge tip. Note: When using Keralac™ NAILSTIK for the first time, it will take a number of turns of the dial before solution appears.
- Using the sponge tip, apply a thin layer of Keralac™ NAILSTIK to the surface of the nail(s) as directed by physician.
- Replace cap immediately to prevent sponge applicator from drying out.
Please see reverse side tor full Prescribing Information.
Manufactured for:
DOAK DERMATOLOGICS
A SUBSIDIARY OF BRADLEY PHARMACEUTICALS, INC.
383 Route 46 West • Fairfield, New Jersey 07004-2402 USA
1-800-405-DOAK • www.doakderm.com
Manufactured by:
Pegasus Laboratories, Inc.
Pensacola, FL 32514
IL240-R2
| KERALAC NAILSTIK
urea solution |
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| Labeler - PharmaDerm a division of Fougera Pharmaceuticals Inc. (043838424) |