Active Ingredient
Allantoin 0.5%
Coats Aloe
FDA Label NDC 58826-703
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tychasis Corporation for the product Coats Aloe (NDC 58826-703). 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, uses:, warnings, caution:, keep out of reach of children, directions:, inactive ingredients:, questions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses:
Skin protectant
Temporarily protects minor:
- cuts
- scrapes
- burns
Helps prevent and temporarily protects and helps relieve chaffed, chapped or cracked skin.
Helps prevent and protect from the drying effects of wind and cold weather.
Warnings
For external use only.
Do not get into eyes.
Stop use and ask a doctor if condition worsens, symptoms last more than 7 days, or clear up and occur again within a few days.
Caution:
Do not use on deep puncture wounds, animal bites, serious burns.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
Apply as needed.
Apply as needed.
Inactive Ingredients:
water, aloe barbadensis leaf juice, caprylic/-capric triglyceride, cetyl alcohol, postassium palmitoyl hydrolyzed wheat protein, glycerol stearate, pentylene glycol, butyrospermum parkii (shea) butter, c12-15 alkyl benzoate, glycerin, beta-glucan, sodium hyaluronate, glyceryl stearate SE, cetearath-20, dehydroacetic acid, benzyl alcohol
Questions:
Toll free number 888-650-0040
Package Label: Coats Aloe Creme 4 Oz
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