Label: UREA- urea cream
- NDC Code(s): 42291-849-19, 42291-849-28, 42291-849-85
- Packager: AvKARE, Inc.
- 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 September 28, 2018
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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
Urea gently dissolves the intracellular matrix which results in loosening of the horny layer of the skin and shedding of scaly skin at regular intervals, thereby softening hyperkeratotic areas of the skin.Close
The mechanism of action of topically applied urea is not yet known.Close
- 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.Close
Known hypersensitivity to any of the listed ingredients.Close
For topical use only. Avoid contact with eyes, lips or mucous membranes.Close
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 and consult a physician.Close
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.Close
- NURSING MOTHERS
NURSING MOTHERS: It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Urea 40% is administered to a nursing woman.Close
- Adverse Reactions
- Dosage and Administration
Apply Urea 40% to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed.Close
Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.
- How Supplied
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.Close
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, Inc. (796560394)