Drug Facts
Drug Facts
First Aid Only Lidocaine Hydrochloride Analgesic Burn Gel
FDA Label NDC 0924-5004
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 Lidocaine Hydrochloride Analgesic Burn Gel (NDC 0924-5004). 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 drug facts, active ingredient, purpose, use, warnings, do not use, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Lidocaine Hydrochloride 2%
Purpose
External Analgesic
Use
for the temporary relief of pain associated with • minor burns
Warnings
For external use only
Avoid Contact with eyes
Do Not Use
• on wounds or damaged skin • in large quantities, particularly over raw surfaces or blistered areas
Stop Use And Ask A Doctor If
• condition worsens or symptoms persist for more than 7 days • symptoms clear up and occur again within a few days
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
• 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: do not use consult a doctor
Other Information
•store at room temperature 15-30°C (59-86°F)
Inactive Ingredients
acrylates/C10-30 alkyl acrylate crosscopolymer, carbomer, glycerin, imidurea, methylparaben, propylene glycol, propylparaben, purified water, tea tree oil, trolamine
Questions?
800-835-2263
Package Labeling:
Carton Label (807113 001 Reva Fda)
* Please review the disclaimer below.
