Otc - Active Ingredient
Lidocaine 0.5%
Meijer Burn Relief Spray
FDA Label NDC 79481-2183
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer for the product Meijer Burn Relief (NDC 79481-2183). 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
External Analgesic
Indications & Usage
For the temporary relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites, and minor skin irritations.
Warnings
For external use only. Flammable--Keep away from fire or flame. Do not use in large quantities, particularly over raw surfaces or blistered areas. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water, do not apply to wounds or damaged skin, and do not bandage tightly, do not use with a heating pad. Contents under pressure. Do not puncture or incinerate. Do not store at temperature 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.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Shake well before use. Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.
Inactive Ingredient
Water, Alcohol Denat., Propylene Glycol, Glycerin, Aloe Barbadnesis Leaf Extract, Tocopheryl Acetate, Disodium Cocoamphodipropionate, Carbomer, Disodium EDTA, Triethanolamine, Diazolidinyl Urea, Propylparaben, Methylparaben, Simethicone.
Package Label.Principal Display Panel
Label (Psys 320820 001)
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