• Active Ingredient
Lidocaine Hydrochloride 2%
First Aid Only Burn Gel
FDA Label NDC 0924-5010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Acme United Corporation for the product First Aid Only Burn (NDC 0924-5010). 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, uses, warnings, do not use, stop use and ask a doctor if, otc - 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
External Analgesic
Uses
Temporarily relieves pain associated with minor burns
Warnings
For external use only.
Avoid contact with eyes
Do Not Use
▪ in large quantities, particularly over raw surfaces or blistered areas
Stop Use And Ask A Doctor If
▪condition worsens
▪symptoms persist for more than 7 days
▪symptoms clear up and occur again in a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
. If swallowed get medical help or contact Poison Control immediately
Directions
Adults and children 2 years and over:
Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age: consult a doctor
Inactive Ingredients
Acrylates/C10-30 alkyl acrylate crosspolymer, Carbomer, Glycerin, Imidazolidinyl urea, Methylparaben, Propylparaben, Propylene Glycol, Purified water, Tea Tree Leaf Oil, Triethanolamine.
Other
QUESTIONS 800-835-2263
* Please review the disclaimer below.
