Otc - Active Ingredient
Ethyl alcohol 70% v/v
Hand Sanitizer
FDA Label NDC 78319-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pafer Foods & Beverages, S. De R.l De C.v. for the product Hand Sanitizer (NDC 78319-006). 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 - do not use, otc - keep out of reach of children, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic
Indications & Usage
- Hand Sanitizer to help reduce bacteria on the skin
- For use when soap and water are not available
- Recommended for repeated use
Warnings
For external use only
Flammable. Keep away from heat or flame
Otc - Do Not Use
Do not use:
- In children less than 2 months of age
- On open skin wounds
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact poison control center right away.
Dosage & Administration
Directions:
Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years in the use of this product.
Other Safety Information
Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredient
Aminoethyl Propanol, Acrylates Copolymer, Glycerin, Hydrogen Peroxide, Purified Water, Fragrance
* Please review the disclaimer below.
