Label: UREA cream
- NDC Code(s): 42291-849-19, 42291-849-28, 42291-849-85
- Packager: AvKARE
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated January 20, 2020
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For external use only. Not for ophthalmic use.
Urea 40% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea 40%contains 40% urea as an active ingredient, and the following inactive ingredients: Ceteareth-6, Ceteareth-25, Cetyl Alcohol, Mineral Oil, Propylene Glycol, Purified Water, Sodium Hydroxide, Stearyl Alcohol, Xanthan Gum.
Urea is a diamide of carbonic acid with the following chemical structure:
- Clinical Pharmacology
Indications and Usage
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, ingrown and devitalized nails.
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, Urea 40% should be given to a pregnant woman only if clearly needed.
- NURSING MOTHERS
- Adverse Reactions
- Dosage and Administration
Urea 40% Cream
1 oz. (28.35 g): NDC 42291-849-28
Urea 40% Cream
3 oz. (85 g): NDC 42291-849-85
Urea 40% Cream
7 oz. (198.4 g): NDC 42291-849-19
Store at room temperature 15°C - 30°C (59°F-86°F).
Protect from freezing. Keep bottle tightly closed.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Pulaski, TN 38478
AV Rev. 09/18 (P) Rev. 09/18
- Tube Label
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-849 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA 40 g in 100 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) XANTHAN GUM (UNII: TTV12P4NEE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PARAFFIN (UNII: I9O0E3H2ZE) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42291-849-28 1 in 1 CARTON 11/06/2017 1 28 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:42291-849-85 1 in 1 CARTON 11/06/2017 2 85 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:42291-849-19 1 in 1 CARTON 11/06/2017 3 198 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/06/2017 Labeler - AvKARE (796560394)