Active Ingredient(S)
Ethyl Alcohol 75% v/v.
Skinact
FDA Label NDC 78160-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Skinact for the product Skinact (NDC 78160-002). 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(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antimicrobial
Use
- For handwashing to decrease bacteria on the skin
- Recommended for repeated use
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
in the eyses. In case of contact, rinse eyes thorooughly with water
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
Stop use and ask a doctor if irritation or redness develop and persist for more than 72 hours
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Wet hands thorooughly with product, briskly rub hands together until dry, supervise children under 6 years in the use of this product.
Other Information
- Store below 110F (43C)
- May discolor certain fabrics
Inactive Ingredients
Water, Glycerin, Carbomer, Triethanolamine, Tocopheryl Acetate,Aloe.
Package Label - Principal Display Panel
Label (Label)
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