Otc - Active Ingredient
Lidocaine HCl 4%
Cvs Maximum Strength Burn Gel
FDA Label NDC 69842-309
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Maximum Strength Burn (NDC 69842-309). 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 otc - active ingredient, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - 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
Indications & Usage
Temporarily relieves pain and itching due to: minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations
Warnings
For external use only
Otc - Do Not Use
In large quantities, particularly over raw surfaces or blistered areas
Otc - When Using
Do not get into eyes
Otc - Stop Use
condition gets worse
symptoms last for more than 7 days
symptoms clear up and occur again within a few days
Otc - 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 and over: apply to affected area not more than 3 to 4 times daily
- children under 2 years: ask a doctor
Otc - Purpose
topical analgesic
Other Information
Store between 20 °C and 25 °C (68 °F and 77 °F)
Inactive Ingredient
Aloe barbadensis (aloe vera) leaf juice, caprylyl glycol, chlorphensin, dimethyl isosorbide, hydroxyethyl cellulose, phenoxyethanol, propanediol, purified water, vitamin E
Recent Major Changes
Uses: Removed title and removed
Directions: Added bullets to separate the requirement
Otc - Questions
call 515-276-1586
Package Label.Principal Display Panel
CVS Health
Maximum Strength Burn Gel
Lidocaine HCl 4%
Topical Analgesic
- Use on sunburns & minor burns
- Past pain & itch relief
- Soothing aloe & vitamin E
* Please review the disclaimer below.
