Otc - Active Ingredient
Active Ingredients
Allantoin
The Melanin Skin Protectant Cream
FDA Label NDC 85514-6539
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reedfresh Co., Ltd for the product The Melanin Skin Protectant Cream (NDC 85514-6539). 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 otc - active ingredient, inactive ingredient, otc - purpose, warnings, these highlights do not include all the information needed to use. see full prescribing information., otc - keep out of reach of children, recent major changes, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive ingredients:
Purified Water, Glycerin, Propylene Glycol, Laurocapram, Niacinamide, Xanthan Gum, Butylene Glycol, Tocopherol, Cetearyl Alcohol, Isohexadecane, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Hydrogenated Lecithin, Cetearyl Glucoside, Polyacrylamide, C13-14 Isoparaffin, 1,2-Hexanediol, Disodium EDTA, Ergothioneine, Selaginella Tamariscina Extract, Ethylhexylglycerin, Glucose, Fragrance, Ginkgo Biloba Leaf Extract, Prunella Vulgairs Extract, Croton Lechleri Resin Extract
Otc - Purpose
Temporarily protects and helps relieve minor skin irritations
Helps protect chapped or cracked skin
Warnings
For external use only
Do not use on deep or puncture wounds, animal bites, or serious burns unless directed by a doctor
Discontinue use and consult a dermatologist if any of the following symptoms occur, as continued use may worsen the condition: 1) Red spots, swelling, itching, or irritation during use; 2) Similar symptoms appearing on the applied area due to direct sunlight exposure
Avoid contact with eyes; if contact occurs, rinse immediately
Keep out of reach of children
Store in a cool, dry place, away from direct sunlight and extreme temperatures
These Highlights Do Not Include All The Information Needed To Use. See Full Prescribing Information.
Apply as needed
Otc - Keep Out Of Reach Of Children
KEEP OUT OF THE REACH OF CHILDREN.
Recent Major Changes
Newly added
Indications & Usage
Temporarily protects and helps relieve minor skin irritations
Helps protect chapped or cracked skin
* Please review the disclaimer below.
