FDA Label for Burn Relief Professional Bio-kool
View Indications, Usage & Precautions
Burn Relief Professional Bio-kool Product Label
The following document was submitted to the FDA by the labeler of this product Kool-down Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Lidocaine - 4.0%
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
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