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Hand Sanitizer

Dosage form
LIQUID
Labeler
Foggy Mountain Spirit Company
Label updated
2020-05-18
Retrieved
2026-09-07
Active ingredients
ALCOHOL
View original label and images on DailyMed ↗
Label information

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

375 sani back FDA.jpg

375 sani front FDA.jpg

750 sani back FDA.jpg

750 sani front FDA.jpg

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Antiseptic Refill

Warnings

External use only. Do Not Ingest. Flammable. Keep away from flame. Keep Out Of Reach of Children. Do Not Use In or Near The Eyes. If Conatct Occurs Flush With Water.

Label information

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Label information

Keep out of reach of children.

Directions
  • Place enough product in palm to thoroughly cover your hands. Rub together briskly until dry.
  • Supervise children when using this product to avoid swallowing.
Other information
  • Store between 15-30C (59-86F)
Inactive ingredients

glycerin, hydrogen peroxide, purified water, BITREX (denaturant)

Package Label - Principal Display Panel

[Image in the official label — see DailyMed source]

[Image in the official label — see DailyMed source]

[Image in the official label — see DailyMed source]

[Image in the official label — see DailyMed source]

375 mL NDC: 74914-001-01

750 mL NDC: 74914-001-02

DailyMed Set ID: a330d224-1863-f6d3-e053-2a95a90a9ec9 · Version 3
NDC: 74914-001