Active Ingredient
Lidocaine 0.5%
Burn Relief Aerosol, Spray
FDA Label NDC 56104-914
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Premier Brands Of America Inc. for the product Burn Relief (NDC 56104-914). 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, extremely flammable:, do not use, when using this product, stop use and ask a doctor if, 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 temporary relief of pain and itching associated with:
- sunburn
- minor cuts
- scrapes
- minor burns
- insect bites
- minor skin irritations
Warnings
For external use only.
Extremely Flammable:
Keep away from fire, sparks, and heated surfaces. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.
Do Not Use
in large quantities, particularly over raw surfaces or blistered areas.
When Using This Product
- avoid spraying in the eyes
- use only as directed
- intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
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 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: do not use, consult a doctor
- to apply to face, spray in palm of hand and gently apply
Other Information
- store between 20° and 25°C (68° and 77°F)
- shake can well before use
Inactive Ingredients
water, butane, propane, propylene glycol, aloe barbadensis leaf juice, carbomer, diazolidinyl urea, disodium cocoamphodipropionate, disodium edta, glycerin, methylparaben, propylparaben, simethicone, tocopheryl acetate, triethanolamine.
Questions?
Call 1-866-964-0939
Principal Display Panel
premier
solutions
BURN
RELIEF
Spray
LIDOCAINE 0.5%/
EXTERNAL ANALGESIC
ALCOHOL-FREE
Relieves pain & itching
from sunburn, minor
burns & insect bites
Cools, moisturizes &
soothes sunburned skin
NET WT. 4.5 OZ. (127g)
* Please review the disclaimer below.
