Active Ingredients
LIDOCAINE HYDROCHLORIDE 2%
Aloe Ice Sunburn Relief Gel
FDA Label NDC 61477-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aloe Care International, Llc for the product Aloe Ice Sunburn Relief (NDC 61477-101). 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 ingredients, purpose, uses, directions, otc - keep out of reach of children, warnings, otc - stop use, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
PAIN RELIEF
Uses
TEMPORARY PAIN ASSOCIATED WITH MINOR BURNS
Directions
APPLY GENEROUSLY TO AFFECTED AREA.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Warnings
FOR EXTERNAL USE ONLY, NOT TO BE SWALLOWED. AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.
Otc - Stop Use
STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR PERSISTS FOR MORE THAN 7 DAYS OR CLEARS UP AND RETURNS.
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Blue 1 (CI 42090), Carbomer, Disodium EDTA, Iodopropynyl Butylcarbamate, Methylisothiazolinone, Polysorbate 20, Propylene Glycol, Triethanolamine, Water
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