Active Ingredient
Lidocaine HCl 2.5%
Unburn Gel
FDA Label NDC 59898-500
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Water-jel Technologies for the product Unburn (NDC 59898-500). 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, when using this product, stop use and ask a doctor if, keep out of the reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External analgesic
Uses
for the temporary relief of pain associated with:
- sunburn
- minor burns
- minor skin irritations
- insect bites
Warnings
For external use only
Do Not Use
- in large quantities, particularly over raw surfaces or blistered areas
When Using This Product
- avoid contact with eyes
Stop Use And Ask A Doctor If
- condition worsens
- symptoms persist for more than 7 days
- condition clears up and occurs again within a few days
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
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: consult a doctor
Other Information
- store at 15 o to 25 oC (59 o to 77 oF)
- do not freeze
- you may report a serious adverse reaction to this product to 1-800-275-3433
Inactive Ingredients
acrylates/C20-30 alkyl acrylate crosspolymer, aloe, carbomer, diazolidnyl urea, edetate disodium, glyceryl-7 stearate, methylparaben, octoxynol-9, polysorbate 20, propylene glycol, propylparaben, purified water, spearmint oil, tea tree oil, trolamine, vitamin E acetate
Otc - Questions
1-800-275-3433
Monday - Friday (9a.m. - 5 p.m. EST)
www.unburn.info
* Please review the disclaimer below.
