The following Structured Product Label (SPL) was submitted to the FDA by Publix Super Markets Inc for the product Publix Burn Relief (NDC 56062-702). 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 active ingredients, otc - purpose, uses, warnings, otc - do not use, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients
Lidocaine 0.50%Menthol 0.10%
Otc - Purpose
Topical Anesthetic
Uses
- temporary relief of pain and itching
- helps relieve and soothes pain from sunburn, minor burns, cuts, scrapes, skin irritations and insect bites
Warnings
For external use only
Otc - Do Not Use
Do not use in large quantities,particularly over raw
surfaces or blistered areas.
When Using This Product
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed get
medical help or contact Poison Control Center immediately.
Directions
- adults and children 2 years of age and older: apply to affected area not
more than 3 to 4 times daily
- children under 2 years of age: do not use, ask a doctor
Inactive Ingredients
Water, Alcohol Denat., Propylene Glycol, Glycerin, Polysorbate 20, Carbomer, Triethanolamine, Diazolidinyl Urea, Aloe Barbadensis Leaf Juice, Tocopherol, Disodium EDTA, Blue 1.
Principal Display Panel
Publixrelieving ALOE VERA GELSOOTHES PAIN WITH LIDOCAINE AND MENTHOLNET WT 16 OZ (454g)
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