Active Ingredient
UREA 20%
Drymatine 20% Urea Cream
FDA Label NDC 84844-009
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guoyu Trading Co., Ltd. for the product Drymatine 20% Urea Cream (NDC 84844-009). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Moisturizer
Use
Soothes, Softens and Moisturizes Dry Rough Skin.
Warnings
For External Use Only.
Do not apply to broken skin. If redness occurs, discontinue use. Avoid contact with eyes.
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.
When Using
Stop use and ask a doctor if redness occurs. Do not apply to broken skin. Avoid contact with eyes.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop Use
Stop use and ask a doctor if redness occurs. Do not apply to broken skin. Avoid contact with eyes.
Ask Doctor
Stop use and ask a doctor if redness occurs.
Keep Oot Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
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.
Other Information
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]
Inactive Ingredients
Cetyl Alcohol, Carbomer, Glycerin, Glyceryl Stearate SE, Mineral Oil, Purified Water, Stearyl Alcohol, Triacetin, White Petrolatum.
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