Otc - Active Ingredient
Active Ingredient
Ethyl Alcohol 75%
Hand Sanitizer
FDA Label NDC 77616-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Klean And Safe Llc for the product Hand Sanitizer (NDC 77616-012). 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, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antiseptic
Indications & Usage
Uses
To decrease bacteria on the skin.
Recommended for repeated use.
Warnings
Warnings
Flammable. Keep away from fire or flame.
For external use only.
Avoid contact with broken skin.
Otc - When Using
When using this product, do not use in or near the eyes.In case of contact, rinse eyes thoroughly with
water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash appears and lasts.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help.
Dosage & Administration
Directions
Not recommended for infants.
Wet hands thoroughly with product and allow to dry without wiping.
Children under 6 years of age should be supervised when using this product.
Storage And Handling
Other Information
Do not store above 110°F. May discolor some fabrics.
Inactive Ingredient
Inactive Ingredients
Water,Glycerin, Acrylates/C1O-30 Alkyl Acrylate crosspolymer, Triethanoamine, Fragrance.
Package Label.Principal Display Panel
Image Of Tube Label (2oz)
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