Otc-Active Ingredient Section
Active Ingredients
Benzalkonium Chloride 0.13% - First Aid Antiseptic
Lidocain HCl 4% - Topical Analgesic
Walgreens Burn Gel Packettes Gel
FDA Label NDC 0363-2788
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Walgreens Burn Gel Packettes (NDC 0363-2788). 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 section, purpose, indications & usage section, warnings section, otc-ask doctor section, stop use, otc do not use, otc pregnancy or breastfeeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
First aid antiseptic
Topical analgesic
Indications & Usage Section
Uses For temporary relief of pain and itching associated with sunburn, minor burns, minor skin irritation, minor cuts, minor scrapes, insect bites
Warnings Section
Warnings for external use only
Otc-Ask Doctor Section
Ask a doctor if you have deep puncture wounds, animal bites, serious burns
Stop Use
and ask doctor if
condition worsens or does not improve
symptoms persist for more than 7 days or clear up and occur again within a few days
Otc Do Not Use
Do not use in or near the eyes, in large quantities or over large areas of the body, on raw surfaces or blistered areas
Otc Pregnancy Or Breastfeeding Section
If pregnant or breastfeeding ask a health professional before use.
Otc Keep Out Of Reach Of Children Section
Keep out of reach of children. If swallowed, get medical help orn contact a poison control center right away
Instrutions For Use Section
Directions Adults and children 2 years and older. clean the burn area with mild soap and water, apply a small amount of gel to the affected area not more than 3 times daily. May be covered with a sterile bandage (let dry first). Children under 2 years of age consult a doctor.
Storage And Handling Section
Other information,. Store at 15 to 30 degrees C (59-86 degrees F)
Inactive Ingredients Section
1,3-propanediol. aloe barbadensis (aloe) leaf juice, caprylyl chlorphenesin, dimthyl isosorbide hydroxyyethyl cellulose, phenolxyethanol, tocopheryl acetate (Viramin E), Water
Package Label Principal Display Panel
Walgreens Emergency Burn Gel with antiseptic
maximum strength
Lidocaine HCl 4% with aloe
* Please review the disclaimer below.
