Active Ingredient
Active Ingredient
Lidocaine Hydrochloride 2.50%
After Burn Gel
FDA Label NDC 44224-1220
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tender Corporation D/b/a Adventure Ready Brands for the product After Burn (NDC 44224-1220). 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, when using this product, stop use and ask a doctor if, keep out of reach of children, if in eyes, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses
For the temporary relief of pain due to minor burns, sunburns, minor cuts, scrapes, or minor skin irritations
Warnings
for external use only
When Using This Product
avoid contact with eyes
do not use in large quantities, particularly over raw surfaces or blistered areas
do not use longer than 1 week unless directed by doctor
Stop Use And Ask A Doctor If
Condition worsens
Symptoms persist for more than 7 days or clear
up and occur again within a few days.
Keep Out Of Reach Of Children
if swallowed, get medical help or contact poisn control center right away.
If In Eyes
flush with water for 15 minutes and call a doctor
Directions
Clean rg affected area.
Adults and children 2 years of age and older apply a small amount to affected area not more than 3 times daily.
Children under 2 years of age consult a doctor
Inactive Ingredients
Aloe Vera, Benzalkonium Chloride, Carbomer 980, GLycerol USP, Herbal Fragrance, Menthol, Polysorbate 20, Propylene Glycol, Purified Water, Sodium Hydroxide
* Please review the disclaimer below.
