Active Ingredients
80% Ethyl Alcohol (v/v); Purpose: Antiseptic
Hand Sanitizer Who Formulation
FDA Label NDC 77419-0002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amass Brands, Inc for the product Hand Sanitizer Who Formulation (NDC 77419-0002). 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 ingredients, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
Hand sanitizer to help reduce disease-causing bacteria.
Hand sanitizer to help reduce disease-causing bacteria.
Warnings
Flammable. Keep away from heat or flame. For external use only.
Do Not Use
- on children less than 2 months of age or on open skin wounds. Do not use in or near the eyes. in case of eye contact, rinse thoroughly with water.
Otc - When Using
Stop use and ask a doctor if irritation or rash occurs.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a poison center immediately.
Other Information
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
glycerin, hydrogen peroxide, purified water
Dosage & Administration
Apply liberally to dry hands, rub briskly until evaporated.
Children should be supervised when using this product.
Package Label - Principal Display Panel
80% ALCOHOL ANTISEPTIC TOPICAL SOLUTION
Antiseptic Hand Rub Non-Sterile Solution
12 oz | 355 mL
80% Alcohol v/v
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