Active Ingredient
Lidocaine - 3.9%
Burn Relief Extra Strength
FDA Label NDC 61566-117
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 Extra Strength (NDC 61566-117). 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 ingredient, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredients, 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
Purpose
Topical Pain Reliever
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Uses
Temporarily relieves pain due to:
- burns
- insect bites
- 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
• symptoms last more than 7 days or clear up and occur again within a few days.
Directions
Adults and children 5 years of age and older: apply to affected area not more that 3-4 times daily. Children under 5 years of age: ask a doctor.
Inactive Ingredients
Aloe Barbadensis Leaf Juice
Glycerin
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
Canola Oil
Fragrance
Package Label.Principal Display Panel
Image Description (Label)
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