URE-39 Cream

Name: URE-39 Cream

Precautions

Stop use and ask a doctor if redness or irritation develops. After applying this medication, wash hands and unaffected areas thoroughly. If swallowed, get medical help or contact Poison Control Center right away. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

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 reproduction studies are not always predictive of human response, URE-39 Cream 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 URE-39 Cream is administered to a nursing woman.

Adverse Reactions

Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.

URE-39 - Dosage and Administration

Apply URE-39 Cream to affected skin two to three times per day as needed or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue two to three times per day or as directed by a physician. Best applied to affected areas immediately after showering and just before bedtime.

How is URE-39 Supplied

URE-39 (39% Urea Cream) is supplied in:

8oz (227gm) Jar NDC: 70350-2612-1

Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59° - 86°F). Protect from freezing. [See USP Controlled Room Temperature.]

Manufactured for:
Solutech Pharmaceuticals LLC
Peoria, AZ 85345

Rx only

PRINCIPAL DISPLAY PANEL - 227 gm Jar Label

NDC 70350-2612-1

FOR TOPICAL USE ONLY

URE-39
UREA 39% CREAM

Smooth Easily Spreadable

Rx only

Solutech
PHARMACEUTICALS

Net WT.
8OZ (227 gm)

URE-39 
urea cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70350-2612
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 390 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
SAFFLOWER OIL  
GLYCERIN  
PROPYLENE GLYCOL  
GLYCERYL MONOSTEARATE  
PEG-100 STEARATE  
CETYL ALCOHOL  
DIMETHICONE  
ALKYL (C12-15) BENZOATE  
CHAMAEMELUM NOBILE FLOWER  
TEA TREE OIL  
ALOE VERA LEAF  
PHENOXYETHANOL  
METHYLPARABEN  
ETHYLPARABEN  
BUTYLPARABEN  
PROPYLPARABEN  
ISOBUTYLPARABEN  
Packaging
# Item Code Package Description
1 NDC:70350-2612-1 227 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 09/01/2017
Labeler - SOLUTECH PHARMACEUTICALS LLC (080040396)
Revised: 03/2018   SOLUTECH PHARMACEUTICALS LLC
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