Garrison Brothers Distillery Hand Sanitizer: Package Insert and Label Information

GARRISON BROTHERS DISTILLERY HAND SANITIZER- alcohol liquid
Garrison Brothers Distillery

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.

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.

Alcohol 80% v/v. Purpose: Antiseptic

COMPOSITION: ethanol or isopropanol, glycerol and hydrogen peroxide. WHO-RECOMMENDED HANDRUB FORMULATION: Whitedog (ethanol) – 80% volume/volume, Glycerol (1.45% v/v), Hydrogen peroxide (.125% v/v), boiled rainwater. FOR EXTERNAL USE ONLY: Avoid contact with eyes. Keep out of reach of children. FLAMMABLE: Keep away from flame and heat. USE: Apply a palmful of alcohol-based hand rub and cover all surfaces of the hands. Rub hands until dry.

Purpose

Use(s)

Hand Sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are not available.

Use

Uses: Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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.

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

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.

Do not use

• in children less than 2 months of age
• on open skin wounds

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

• 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)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label — Principal Display Panel

120ML 77293-0001-1 NDC

COMPOSITION: ethanol or isopropanol, glycerol and hydrogen peroxide. WHO-RECOMMENDED HANDRUB FORMULATION: Whitedog (ethanol) – 80% volume/volume, Glycerol (1.45% v/v), Hydrogen peroxide (.125% v/v), boiled rainwater. FOR EXTERNAL USE ONLY: Avoid contact with eyes. Keep out of reach of children. FLAMMABLE: Keep away from flame and heat. USE: Apply a palmful of alcoholbased handrub and cover all surfaces of the hands. Rub hands until dry.

WASH YOUR DAMN HANDS

DATE: BATCH:

GARRISON BROTHERS DISTILLERY HAND SANITIZER garrison brothers hand sanitizer liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77293-0001 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 141.6 mL in 177 mL

Inactive Ingredients Ingredient Name Strength GLYCEROL FORMAL 2.57 mL in 177 mL HYDROGEN PEROXIDE 0.23 mL in 177 mL WATER 32.6 mL in 177 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:77293-0001-3 1893 mL in 1 BOTTLE, PLASTIC None 2 NDC:77293-0001-2 750 mL in 1 BOTTLE, GLASS None 3 NDC:77293-0001-1 177 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020

Labeler — Garrison Brothers Distillery (043768088)

Establishment
Name	Address	ID/FEI	Operations
Garrison Brothers Distillery		043768088	manufacture (77293-0001)

Revised: 05/2020 Garrison Brothers Distillery