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| Product NDC Code | 50268-820 | ||||
|---|---|---|---|---|---|
| Drug Name | Urea 20 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| Labeler Name | AvPAK | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient: UREA 20%
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients : Cetyl Alcohol, Carbomer, Glycerin, Glyceryl Stearate SE, Mineral Oil, Purified Water, Stearyl Alcohol, Triacetin, White Petrolatum.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Usage: Soothes, Softens and Moisturizes Dry Rough Skin.
Purpose
Information about the drug product’s indications for use.Purpose : Moisturizer
Spl product data elements
Usually a list of ingredients in a drug product.Urea 20 Urea CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CETYL ALCOHOL GLYCERIN GLYCERYL STEARATE SE MINERAL OIL WATER STEARYL ALCOHOL TRIACETIN WHITE PETROLATUM UREA UREA Opaque White
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL UREA 20% Cream FOR EXTERNAL USE ONLY. Soothes, Softens and Moisturizes Dry Rough Skin AvKARE NET WT. 3 OZ. (85 g) Manufactured for: AvKARE, Pulaski, TN 38478 www.avkare.com Questions or comments? 1-855-361-3993 AV 04/22 UREA 20% Cream Product No. 50268-820-85 FOR EXTERNAL USE ONLY. Soothes, Softens and Moisturizes Dry Rough Skin AvKARE NET WT. 3 OZ. (85 g) Carton tube
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use: Do not use if safety seal on the tube is broken or missing. For lot number and exp. date, see crimp of tube or carton.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN. For External Use Only.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-855-361-3993
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use: Do not apply to broken skin. If redness occurs, discontinue use. Avoid contact with eyes.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.Directions: Apply to desired areas of the hands, feet, knees, or elbows twice daily, or as directed by a physician. Rub into the skin until fully absorbed. Do not use on tender skin areas such as the face, neck, or scalp.
Storage and handling
Information about safe storage and handling of the drug product.Storage: Store at 20°C (68°F - 77°F), excursions permitted between 15°C and 30°C (59°F - 86°F). Protect from Freezing. Store in a cool dry place. [See USP Controlled Room Temperature]
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS SECTION Caution: Do not apply to broken skin. If redness occurs, discontinue use. Avoid contact with eyes.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API