HAND SANITIZER- alcohol liquid 
Beattie's Distillers Inc.

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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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.

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer kills harmful bacteria or germs.

Warnings

Flammable, keep away from fire, open flame or other sources of heat.

Do not use

For external use only. Keep out of reach of children. When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water. If irritation develops, discontinue use and consult health care professional.

Stop use and ask a doctor if irritation or rash occurs.

Keep out of reach of children.

Directions

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

4 L NDC: 77427-7427-4 4 L Front Label4 L Back Label

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77427-7444
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 L  in 1 L
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 0.0145 L  in 1 L
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.00125 L  in 1 L
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77427-7444-44 L in 1 JUG; Type 0: Not a Combination Product04/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Beattie's Distillers Inc. (203589130)
Registrant - Beattie's Distillers Inc. (203589130)
Establishment
NameAddressID/FEIBusiness Operations
Beattie's Distillers Inc.203589130manufacture(77427-7444)

Revised: 1/2022
Document Id: d65a57d2-6a53-b743-e053-2995a90a57d1
Set id: a93ee1ff-ae04-eb46-e053-2a95a90a443c
Version: 2
Effective Time: 20220124
 
Beattie's Distillers Inc.