Label: UREA cream
- NDC Code(s): 50268-872-19, 50268-872-28, 50268-872-85
- Packager: AvPAK
- 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.
Drug Label Information
Updated February 24, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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DESCRIPTION
Rx Only
For external use only. Not for ophthalmic use.
Description
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:
Carbomer, Cetearyl Alcohol, Glycerin,
Glyceryl Stearate SE, Mineral Oil, Purified Water,
White Petrolatum
Urea is a diamide of carbonic acid with the following chemical structure:
- Clinical Pharmacology
- Pharmacokinetics
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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.
- Contraindications
- Warnings
- Precautions
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PREGNANCY
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
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Adverse Reactions
Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication.
To report SUSPECTED ADVERSE REACTIONS contact AvKARE at 1-855-361-3993; email drugsafety@avkare.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- Dosage and Administration
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How Supplied
Urea 40% Cream
1 oz. tube (28.35 g) NDC 50268-872-28
3 oz. tube (85 g) NDC 50268-872-85
7 oz. bottle (198.4 g) NDC 50268-872-19
Store at room temperature 15°C - 30°C (59°F-86°F).
Protect from freezing. Keep bottle tightly closed.
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured for:
AvKARE
Pulaski, TN 38478www.avkare.com
AV Rev. 6/22 Rev. 6/22 - Tube Label
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INGREDIENTS AND APPEARANCE
UREA
urea creamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-872 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) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) MINERAL OIL (UNII: T5L8T28FGP) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER 940 (UNII: 4Q93RCW27E) PETROLATUM (UNII: 4T6H12BN9U) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50268-872-28 28.35 g in 1 TUBE; Type 0: Not a Combination Product 07/13/2022 2 NDC:50268-872-19 198.4 g in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2023 3 NDC:50268-872-85 85 g in 1 TUBE; Type 0: Not a Combination Product 02/24/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 07/13/2022 Labeler - AvPAK (832926666)