BTS-72- alcohol liquid 
Didion Ethanol, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Alcohol for Hand Sanitizer

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

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.

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.

Directions

Other information

Inactive ingredients

Denatonium Benzoate

Package Label - Principal Display Panel

30280 L label

BTS-72 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74519-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL95 L  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O) 0.000488336 L  in 100 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74519-000-0030280 L in 1 TANK; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/2020
Labeler - Didion Ethanol, LLC (804407612)

Revised: 4/2020
Document Id: a2408db5-aabb-27a5-e053-2a95a90a6be3
Set id: a2408db5-aac9-27a5-e053-2a95a90a6be3
Version: 1
Effective Time: 20200401
 
Didion Ethanol, LLC