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NDC 59088-0489-16 Urea 41% 410 mg/g Details
Urea 41% 410 mg/g
Urea 41% is a TOPICAL CREAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PureTek Corporation. The primary component is UREA.
Product Information
| NDC | 59088-0489 |
|---|---|
| Product ID | 59088-489_da5d8eae-8d63-d354-e053-2995a90a7999 |
| Associated GPIs | 90660080003726 |
| GCN Sequence Number | 071410 |
| GCN Sequence Number Description | urea CREAM (G) 41 % TOPICAL |
| HIC3 | L5A |
| HIC3 Description | KERATOLYTICS |
| GCN | 35185 |
| HICL Sequence Number | 002716 |
| HICL Sequence Number Description | UREA |
| Brand/Generic | Generic |
| Proprietary Name | Urea 41% |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Urea |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 410 |
| Active Ingredient Units | mg/g |
| Substance Name | UREA |
| Labeler Name | PureTek Corporation |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 59088-0489-16 (59088048916)
| NDC Package Code | 59088-489-16 |
|---|---|
| Billing NDC | 59088048916 |
| Package | 227 g in 1 BOTTLE (59088-489-16) |
| Marketing Start Date | 2022-06-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL da5d8eae-8d64-d354-e053-2995a90a7999 Details
DESCRIPTION
Urea 41% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram contains 410 mg of urea in a vehicle consisting of: Aqua (Purified Water), Ceteareth-6, Ceteareth-25, Cetyl Alcohol, Methylparaben, Paraffin, Propylene Glycol, Stearyl Alcohol, Xanthan Gum.
Urea is a diamide of carbonic acid with the following chemical structure:
CLINICAL PHARMACOLOGY
INDICATIONS & 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
FOREXTERNALUSEONLY.NOTFOR OPHTHALMIC USE. KEEP OUT OF REACH OF CHILDREN.
Avoid contact with eyes, lips and mucous membranes.
General
This product 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.
Information for Patients
Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes.
Carcinogenesis, Mutagenesis and Impairment of Fertility:
Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed.
Pregnancy:
Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.
ADVERSE REACTIONS:
DOSAGE AND ADMINISTRATION
STORAGE
Urea 41% Cream™
INGREDIENTS AND APPEARANCE
| UREA 41%
urea cream |
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| Labeler - PureTek Corporation (785961046) |