Otc - Active Ingredient
Benzocaine 20%, Menthol 0.5%
Pain, Burn, And Itch Relief Spray
FDA Label NDC 72839-343
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Derma Care Research Labs, Llc for the product Pain, Burn, And Itch Relief (NDC 72839-343). 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 - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, 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 the temporary relief of pain and itching associated with sunburn, minor skin irritations, insect bites, scrapes, minor cuts, and minor burns.
Warnings
For external use only. Flammable--Keep away from fire or flame. Allergyalert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics. When using this product avoid contact with eyes. Do not spray in the face or mouth. Use only as directed. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days, itching, rash or irritation develops.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
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: ask 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 the button to activate the spray. To apply to face, spray into palm of hand and gently apply.
Inactive Ingredient
Acetylated Lanolin Alcohol, Alcohol Denat., Aloe Barbadensis Leaf Extract, Cetyl Acetate, Helianthus Annuus (Sunflower) Seed Oil, PEG-8 Laurate, Polysorbate 85.
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