Active Ingredient(S)
Alcohol 80% v/v. Purpose: Antiseptic
Hand Sanitizer
FDA Label NDC 80252-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fresh Sanitizer, Llc for the product Hand Sanitizer (NDC 80252-100). 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
Antiseptic, Hand Sanitizer
Use
Hand Sanitizer to help reduce bacteria on the skin. For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from heat or flame. Do not consume.
Do Not Use
- in children less than 2 months of age
- on open skin wounds
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 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 Control Center right away.
Directions
- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
- May discolor fabrics.
Inactive Ingredients
denatonium benzoate, glycerin, hydrogen peroxide, orange flavor, purified water USP
Package Label - Principal Display Panel
100 mL
NDC: 80252-100-01
3785 mL or 3.785L or 1 Gallon
NDC: 80252-100-02
250mL
NDC: 80252-100-03
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