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NDC 50096-0501-05 Urea 47% Cream 470 mg/g Details
Urea 47% Cream 470 mg/g
Urea 47% Cream is a TOPICAL CREAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Rosemar Labs, LLC. The primary component is UREA.
Product Information
| NDC | 50096-0501 |
|---|---|
| Product ID | 50096-501_7cec1e16-8165-13c7-e053-2991aa0ae0f4 |
| Associated GPIs | 90660080003732 |
| GCN Sequence Number | 072166 |
| GCN Sequence Number Description | urea CREAM (G) 47 % TOPICAL |
| HIC3 | L5A |
| HIC3 Description | KERATOLYTICS |
| GCN | 36285 |
| HICL Sequence Number | 002716 |
| HICL Sequence Number Description | UREA |
| Brand/Generic | Generic |
| Proprietary Name | Urea 47% Cream |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | UREA |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 470 |
| Active Ingredient Units | mg/g |
| Substance Name | UREA |
| Labeler Name | Rosemar Labs, LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 50096-0501-05 (50096050105)
| NDC Package Code | 50096-501-05 |
|---|---|
| Billing NDC | 50096050105 |
| Package | 142 g in 1 BOTTLE, PLASTIC (50096-501-05) |
| Marketing Start Date | 2011-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 2c9f0153-4502-4721-9b41-8888f2729714 Details
DESCRIPTION:
CLINICAL PHARMACOLOGY:
INDICATIONS AND USAGE:
CONTRAINDICATIONS:
PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
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.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
ADVERSE REACTIONS:
DOSAGE AND ADMINISTRATION:
STORAGE:
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.
NOTICE: Protect from freezing and excessive heat.
Keep bottle tightly closed.
HOW SUPPLIED:
INGREDIENTS AND APPEARANCE
| UREA 47% CREAM
urea cream |
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| Labeler - Rosemar Labs, LLC (078461488) |