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Uramaxin Lotion

Generic Name: urea
Dosage Form: topical lotion

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.

Uramaxin (45% Urea) Lotion

For external use only. Not for ophthalmic use.

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

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, 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 reproductive studies are not always predictive of human response, UramaxinTM (45% Urea) Lotion 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 UramaxinTM (45% Urea) Lotion 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 UramaxinTM (45% Urea) Lotion to affected skin twice per day, or as directed by a physician.

HOW SUPPLIED:
UramaxinTM (45% Urea) Lotion
16 oz. bottle, NDC 43538-230-16

Also available:
UramaxinTM (45% Urea) Cream

9 oz. tube, NDC 43538-210-09


UramaxinTM (45% Urea) Nail Gel
28 mL bottle, NDC 43538-200-28

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

Protect from freezing.


Manufactured for:

MEDIMETRIKS PHARMACEUTICALS, INC.

363 Route 46 West
Fairfield, NJ 07004-2402 USA

www.medimetriks.com


Manufactured by:
Groupe PARIMA, Inc.
Montreal, QC H4S 1X6 CANADA


URAMAXIN 
urea lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43538-230
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 (SYNTHETIC)  
EDETATE DISODIUM  
ALCOHOL  
EUCALYPTUS OIL  
HYDROXYETHYL CELLULOSE (4000 CPS AT 1%)  
LEVOMENTHOL  
WATER  
TITANIUM DIOXIDE  
Packaging
# Item Code Package Description
1 NDC:43538-230-16 1 BOTTLE (BOTTLE) in 1 CARTON
1 454 g in 1 BOTTLE
2 NDC:43538-230-99 12 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/02/2009
Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)
Registrant - Groupe PARIMA, Inc. (252437850)
Establishment
Name Address ID/FEI Operations
Groupe PARIMA, Inc. 252437850 manufacture
Revised: 10/2010
 
Medimetriks Pharmaceuticals, Inc.



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