FDA Label for Urea 20
View Indications, Usage & Precautions
Urea 20 Product Label
The following document was submitted to the FDA by the labeler of this product Oncor Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient:UREA 20%
Otc - Purpose
Intensive Hydrating Cream:
- Moisturizes to help relieve rough, cracked skin caused by dryness.
- Helps to restore skin's natural moisture barrier.
Inactive Ingredient
INGREDIENTS: Cetyl Alcohol, Carbomer, Glycerin, Glyceryl Stearate SE, Mineral Oil, Purified Water, Stearyl Alcohol, Triacetin, White Petrolatum.
Indications & Usage
Usage: Deeply Moisturizes Skin.
Warnings Section
Caution:Do not use on tender skin areas such as the face, neck, or scalp. Do not apply to broken skin, If redness occurs, discontinue use. Avoid contact with eyes.
Otc - Do Not Use
Do not use if safety seal on the tube is broken or missing.
Storage And Handling
Storage: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Protect from freezing and avoid excessive heat.
Otc - When Using
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.
Otc - Questions
You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST),
at 1-443-876-7900 or FDA at 1-800-FDA-1088.
Otc - Keep Out Of Reach Of Children
CAUTION : USE ONLY AS DIRECTED. FOR EXTERNAL USE ONLY.
KEEP OUT OF REACH OF CHILDREN.
Other
Manufactured In USA For:
ONCOR PHARMACEUTICALS
8815 Center Park Dr Suite 430
Columbia
Maryland 21045
Rev. 05/24
Package Label.Principal Display Panel
ONCOR PHARMACEUTICALS
NDC 83720-561-03
UREA 20%
Intensive Hydrating Cream
Deeply Moisturizes Skin
For external use only
NET WT. 3 OZ. (85 g)
ONCOR PHARMACEUTICALS
NDC 83720-561-03
UREA 20% Cream
Intensive Hydrating Cream
Deeply Moisturizes Skin
For external use only
NET WT. 3 OZ. (85 g)
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