Otc - Active Ingredient
Active Ingredients
Benzalkonium Chloride 0.13%
Lidocaine 4%
Foot Works Maximum Cracked Heel Cream
FDA Label NDC 68577-195
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmax Usa, Corporation for the product Foot Works Maximum Cracked Heel (NDC 68577-195). 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 - do not use, otc - keep out of reach of children, directions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
First aid antiseptic
External analgesic
Uses
Uses
- first aid to help reduce the risk of skin infection in minor cuts, scrapes and burns
- first aid for the temporary reflief of pain in minor cuts, scrapes and burns
Warnings
Warnings
For external use only
Otc - Do Not Use
- do not use in the eyes or apply over large areas of the body
- do not use in large quantities, particularly over raw surfaces or blistered areas
- consult a doctor in the case of deep or puncture wounds, animal bites, or serious burns
- if condition worsens, of if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. Do not use longer than 1 week unless directed by a doctor
Otc - Keep Out Of Reach Of Children
Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Directions
Adults and children 2 years of age and older
- clean the affected area
- apply a small amount of this product on the affected are 1 to 3 times daily
- may be covered with a sterile bandage
- consult a doctor
Children under 2 years of age
Inactive Ingredient
Inactive Ingredients:
Water, Isopropyl Palmitate, Glyceryl Stearate, Cetyl Alcohol, Stearyl Alcohol, Glycerin, Lanolin Wax, Dimethicone, Helianthus Annuus (Sunflower) Seed Oil, Polysorbate 80, Benzyl Alcohol, Carbomer, Methylparaben, Disodium EDTA, Allantoin, Alcohol, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Citric Acid
Package Label.Principal Display Panel
Pkg (Avon Fwcracked Pkg)
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