Active Ingredient
Allantoin 0.5%
Coats Aloe
FDA Label NDC 58826-702
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 58826-702). 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, warnings, otc - stop use, otc - do not use, uses, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin protectant
Warnings
For external use only.
When using this product do not get into eyes.
Otc - Stop Use
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
Otc - Do Not Use
Do not use on deep puncture wounds, animals bites, serious burns.
Uses
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.
Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Apply as needed.
Inactive Ingredients
aloe barbadenesis leaf juice, ethylhexyl palmitate, glycerin, methyl gluceth-20, glyceryl stearate, C12-15 alkyl benzoate, water, cetyl alcohol, triethanolamine, stearice acid, ethylhexyl stearate, diethylhexyl adipate, retinyl palmitate, tocopheryl acetate, laureth-4, laureth-23, carbomer, diazolidinyl urea, methylparaben, propylparaben
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