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Uramaxin GT

Generic Name: urea
Dosage Form: gel, pre-filled-applicator

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)GT PRE-FILLED APPLICATOR

PATIENT INSTRUCTIONS

1. Apply Uramaxin GT to affected nails or skin twice per day, or as directed by a physician.
2. After application, wipe the tip of the tube to remove excess product. Securely place cap back on the tube.

DESCRIPTION:Uramaxin (45% Urea) GT is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Uramaxin (45% Urea) GT 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:

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 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, Uramaxin (45% Urea) GT 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 Uramaxin (45% Urea) GT 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: DIRECTIONS FOR NAILS: Apply Uramaxin (45% Urea) GT to diseased or damaged nail tissue twice per day, or as directed by a physician.

DIRECTIONS FOR SKIN: Apply Uramaxin (45% Urea) GT to affected area(s) twice per day, or as directed by a physician.

HOW SUPPLIED:
Uramaxin (45% Urea) GT 20 mL tube, NDC 43538-250-20

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

PRINCIPAL DISPLAY PANEL - 20 mL Tube Label

NDC 43538-250-20

Rx Only
Uramaxin®GT
(45% UREA)
PRE-FILLED APPLICATOR

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In a vehicle containing Menthol, Camphor and Eucalyptus Oil

0.68 FL OZ (20 mL)
FOR TOPICAL USE ONLY

MEDIMETRIKS
PHARMACEUTICALS, INC.

PRINCIPAL DISPLAY PANEL - 20 mL Tube Carton

NDC 43538-250-20

FOR TOPICAL USE ONLY

Rx Only
Uramaxin®GT
(45% UREA)
PRE-FILLED APPLICATOR

MEDIMETRIKS
PHARMACEUTICALS, INC.

In a vehicle containing Menthol, Camphor and Eucalyptus Oil

0.68 FL OZ (20 mL)

PRINCIPAL DISPLAY PANEL - 20 mL Tube/255 g Tube Kit Carton

NDC 43538-251-20

Rx Only
Uramaxin®GT KIT
(45% UREA)

KIT CONTENTS:
1 - 0.68 fl. oz. Uramaxin® (45% Urea) GT Pre-filled Applicator Tube
1 - 9 oz. (255 g) Tube Keradan™ Cream

MEDIMETRIKS
PHARMACEUTICALS, INC.

Established Pharmacological Class
Substance Pharmacological Class
Keradan Moisturizing
URAMAXIN  GT
urea gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43538-250
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
CAMPHOR (SYNTHETIC)  
EDETATE DISODIUM  
EUCALYPTUS OIL  
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)  
LEVOMENTHOL  
PROPYLENE GLYCOL  
WATER  
Packaging
# Item Code Package Description
1 NDC:43538-250-20 1 TUBE, WITH APPLICATOR (TUBE) in 1 CARTON
1 20 mL in 1 TUBE, WITH APPLICATOR
2 NDC:43538-250-99 5 mL in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/08/2010
Uramaxin GT 
Uramaxin GT and keradan kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43538-251
Packaging
# Item Code Package Description
1 NDC:43538-251-20 1 KIT (KIT) in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE, WITH APPLICATOR 20 mL
Part 2 1 TUBE 255 g
Part 1 of 2
Uramaxin GT 
urea gel
Product Information
     
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
CAMPHOR (SYNTHETIC)  
EDETATE DISODIUM  
EUCALYPTUS OIL  
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)  
LEVOMENTHOL  
PROPYLENE GLYCOL  
WATER  
Packaging
# Item Code Package Description
1 20 mL in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 07/30/2010
Part 2 of 2
KERADAN 
inert cream
Product Information
     
Route of Administration TOPICAL DEA Schedule     
Ingredients
Ingredient Name Quantity
water  
cetostearyl alcohol  
medium-chain triglycerides  
glycerin  
cetyl alcohol  
petrolatum  
polyoxyl 20 cetostearyl ether  
myristyl trisiloxane  
cyclomethicone 5  
cyclomethicone 4  
stearic acid  
paraffin  
polysorbate 20  
phenoxyethanol  
silicon dioxide  
xanthan gum  
cholesterol  
allantoin  
yellow wax  
methylparaben  
linoleic acid  
trolamine  
edetate disodium  
squalane  
alpha-tocopherol acetate  
microcrystalline wax  
olive oil  
aluminum acetate  
aluminum sulfate  
calcium acetate  
sodium lauroyl lactylate  
linolenic acid  
hyaluronate sodium  
ceramide 3  
ceramide 6 II  
tocopherol  
ceramide 1  
Packaging
# Item Code Package Description
1 255 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 08/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 04/15/2012
Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)
Registrant - Groupe PARIMA, Inc. (252437850)
Establishment
Name Address ID/FEI Operations
IGI Laboratories 011036910 manufacture
Revised: 04/2012
 
Medimetriks Pharmaceuticals, Inc.



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