Otc - Active Ingredient
Active ingredients
Allantoin 1.5% (w/w)
Lidocaine Hydrochloride 4.0% (w/w)
Menthol 1.0% (w/w)
Burn Relief
FDA Label NDC 72042-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Humn Pharmaceuticals Inc for the product Burn Relief (NDC 72042-003). 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 - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Skin protectant
Anesthetic
Analgesic, anesthetic, and antipruritic
Indications & Usage
Uses
Temporary relief of pain associated with:
▪ minor burns ▪ minor skin irritations
Temporary protection of minor skin irritations
Warnings
Warnings
For external use only.
Otc - Do Not Use
Do not use
in large quantities, particularly:
• over raw surfaces • over blistered areas
Otc - Ask Doctor
Ask a doctor before use
if child is under 2 years of age, and use only as directed
Otc - When Using
When using this product
• avoid contact with eyes; if this happens, rinse thoroughly with water
Otc - Stop Use
Stop use and ask a doctor
• condition worsens • if symptoms persist for more than 7 days
• clear up and occur again within a few days • you experience: pain, swelling, or blistering
• you experience: weakness, confusion, headache, difficulty breathing, or any unusual symptoms
• you experience: pale, grey or blue-coloured skin, lips, or nail beds
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get
medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
Information For Patients
Other information
• do not use if seal is broken
• store at 60-85° F
Inactive Ingredient
Inactive ingredients
Acrylates/Acrylamide Copolymer, Alpha-Lipoic Acid, Beeswax, Butylene Glycol, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceteraryl Alcohol, Ceteth-20, Ceteth-10 Phosphate, Denatured Alcohol, Dicetyl Phosphate, Dimethicone, Glycerin, Glyceryl Stearate, Iodopropynyl Butylcarbamate, Isopropyl Myristate, Laureth-7, Lecithin, Mineral Oil, PEG-6 Stearate, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate 85, Purified Water, Steareth-2, Steareth-20, Steareth-21.
Otc - Questions
Questions?
1-866-335-3596 Monday to Friday 8 am to 6 pm EST .
Package Label.Principal Display Panel
Burn Relief Label.jpg
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