Label: UREA CREAM 40%- urea cream
- NDC Code(s): 0904-7167-23, 0904-7167-83, 0904-7167-99
- Packager: Major Pharmaceuticals
- 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 October 5, 2023
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
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DESCRIPTION
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: 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
- PHARMACOKINETICS
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INDICATIONS & USAGE
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 eshar. 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
PREGNANACY
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
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DOSAGE & ADMINISTRATION
Dosage and Administration
Apply Urea 40% to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed.
Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.
All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each person's professional opinion and knowledge, upon evaluation of the active ingredients, excipients, inactive ingredients and chemical information provided herein.
- HOW SUPPLIED
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
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SPL UNCLASSIFIED SECTION
MAJOR ®
NDC 0904-7167
Urea Cream 40%
For topical use only
Not for ophthalmic use
Rx Only
DOSAGE AND ADMINISTRATION: Use as directed by your physician. See insert for full prescribing information.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
For lot number and expiration date, see bottom of bottle.
Distributed by:
MAJOR ® PHARMACEUTICALS
Livonia, MI 48152
Rev. 01/23
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PRINCIPAL DISPLAY PANEL
All prescription substitutions and / or recommendations using this product shall be made subject to state and federal statutes as applicable. Pleaes note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Please see package insert for more details.
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INGREDIENTS AND APPEARANCE
UREA CREAM 40%
urea creamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-7167 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA 400 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) XANTHAN GUM (UNII: TTV12P4NEE) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CETEARETH-6 (UNII: 2RJS3559D3) CETEARETH-25 (UNII: 8FA93U5T67) MINERAL OIL (UNII: T5L8T28FGP) CETYL ALCOHOL (UNII: 936JST6JCN) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-7167-83 1 in 1 CARTON 07/06/2021 1 85 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:0904-7167-23 1 in 1 CARTON 07/06/2021 2 28.35 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:0904-7167-99 1 in 1 CARTON 10/04/2023 3 198.4 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 07/06/2021 Labeler - Major Pharmaceuticals (191427277)