Active Ingredient
Lidocaine HCl 2.0%
Redicare Burn Gel
FDA Label NDC 71105-500
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Redicare Llc for the product Redicare Burn Gel (NDC 71105-500). 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, stop use and ask doctor, 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
Topical pain relief
Uses
Temporary pain relief for minor burns
Warnings
For external use only
Do Not Use
- In large quantities, particularly over raw or blistered areas
- near eyes, if this happens rinse thoroughly with water.
Stop Use And Ask Doctor
if condition worsens or persists for more than 7 days or clears up and occurs 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
- for adults and children 2 years and older: apply to affected area not more than 4 times daily
- children under 2: do not use, consult a doctor
Inactive Ingredients
- aloe vera
- carbomer
- germaben II
- propylene glycol
- purified water
- menthol
- triethanolamine
- vitamin E acetate
Package Label.Principal Display Panel
REDICARE
BURN GEL
for minor burns, scalds & sunburn
WITH ALOE VERA FOR BEST RELIEF
3.5g / 1/8 oz.
NDC 71105-500-01
DRUG FACTS...
Packet (0.125oz Burngel Pouch Template)
* Please review the disclaimer below.
