Walgreens Max Strength Burn Gel
FDA Label NDC 0363-9654
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens Co. for the product Walgreens Max Strength Burn Gel (NDC 0363-9654). 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 drug facts, active ingredients, purpose, uses:, warnings, ask a doctor before use if you have:, do not use:, 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
Active Ingredients
Benzalkonium Cl 0.13%
Lidocaine HCI 4%
Purpose
First aid antiseptic
Topical pain relief
Uses:
First aid to help prevent bacterial contamination or skin infection, and for temporary relief of pain and itching associated with minor:
- Burns
- Cuts
- Sunburn
- Scrapes
- Minor Skin Irritation
Warnings
For external use only
Ask A Doctor Before Use If You Have:
- Deep or puncture wounds
- Animal bite
- Serious burns
Do Not Use:
- In or near the eyes
- In large quantities or over large areas of the body
- On raw surfaces or blistered areas
Stop Use And Ask A Doctor If:
- Condition worsens
- Symptoms last more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast-Feeding,
ask a health care professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions:
Adults and children 2 years of age & older:
- Clean the affected area. Apply a small amount of gel on the affected area 1 to 3 times daily.
- May be covered with a sterile bandage (let dry first).
- cover with adhesive bandage or sterile gauze if needed
- apply 1 to 3 times daily.
- ask a doctor
Children under 2 years of age:
Other Information:
- Store at room temperature 15° -30°C (59° -86°F)
Inactive Ingredients:
Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Chlorophenesin, Dimethyl lsosorbide, Hydroxyethyl Cellulose, Phenoxyethanol, Propanediol, Tocopheryl Acetate (Vitamin E), Water.
Package Labeling:
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