Otc - Active Ingredient
20% Benzocaine
0.5% Menthol
Walgreens Pain Burn Itch Relief Spray
FDA Label NDC 0363-2053
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 Pain Burn Itch Relief (NDC 0363-2053). 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, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Indications & Usage
For temporary relief of pain and itching associated with :
- sunburn
- insect bites
- minor cuts
- scrapes
- minor burns
- minor skin irritations
Warnings
For External use only
Otc - Do Not Use
Flamable:
- Do not use near heat, flame, or fire or while smoking
- Do not use this product if you have a history of allergy to local anesthetics such as procaine, benzocaine or other "caine" anesthetics.
Allergy Alert:
Otc - When Using
Avoid contact with eyes. Do not spray in the face or mouth
Use only as ditected
Intentional misuse by delibrately concentrating or inhailing the contents can be harmful or fatal
Do not puncture or incinerate.Contents under pressure. Do not store at temperatures above 120°F.
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens or symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
- itiching, rash or irritation develops
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poision Control Center right away. (1-800-222-1222)
Dosage & Administration
Adults and children 2 years of age and older : Apply to the affected area not more than 3 to 4 times daily
Children under 2 years of age: Cinsult a doctor
- To use this product, hold the can 6 to 12 inches away from the affected area. Direct spray nozzle towards skin and press button to activate spray.
- To apply to face, spray in palm of hand and gently apply.
Other Safety Information
- Avoid contact with leather, fabric and upholstery to prevent possible staining or discoloration
- Store at 20-25°C (68-77°F)
Inactive Ingredient
Aloe Vera, Phenoxyethanol, Polyethylene Glycol 400, Tetrafluoroethane
Otc - Questions
1-800-925-4733
* Please review the disclaimer below.
