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BTS-72

Dosage form
LIQUID
Labeler
Didion Ethanol, LLC
Label updated
2020-04-01
Retrieved
2026-09-07
Active ingredients
ALCOHOL
View original label and images on DailyMed ↗
Label information

This is a denatured ethanol manufactured for a hand sanitizer 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 denatured ethanol 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) (95%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

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

Active Ingredient(s)

Alcohol 95% v/v. Purpose: Antiseptic

Purpose

For use in production of Antiseptic, Hand Sanitizer

Use

Denatured Ethanol for use in production of Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use
  • in children less than 2 months of age
  • on open skin wounds
Label information

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.

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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • For use in production of Hand Sanitizer that meets the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
Other information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive ingredients

Denatonium Benzoate

Package Label - Principal Display Panel

[Image in the official label — see DailyMed source]

DailyMed Set ID: a2408db5-aac9-27a5-e053-2a95a90a6be3 · Version 1
NDC: 74519-000