Otc - Active Ingredient
Lidocaine - 4.0%
Burn Relief Professional Cream
FDA Label NDC 61566-201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kool-down Inc. for the product Burn Relief Professional (NDC 61566-201). 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, uses, 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 Pain Reliever
Uses
Temporarily relieves pain due to: sunburns, burns, insect bites, and itching.
Warnings
For external use only.
Do not use in large quantities, particularity over raw surfaces or blistered areas
When using this product keep out of eyes, use only as directed
Stop use and ask a doctor if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of the children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Adults and children 5 years of age and older: apply to affected area, not more than 3-4 times daily. Children under 5 years of age: ask a doctor.
Inactive Ingredient
Aloe Barbadensis Leaf Juice, Glycerol, Stearic Acid, Glyceryl Stearate SE, Isopropyl Myristate, Ethoxydiglycol, Ozokerite, Polysorbate 80, Carbomer, Zinc Oxide, Allantoin, Ascorbic Acid, Methylparaben, Diazolidinyl Urea, Propylparaben, Triethanolamine, Tetrasodium EDTA, Tocopheryl Acetate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Fragrance.
Package Label.Principal Display Panel
Image Description (Label)
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