Label: GARRISON BROTHERS DISTILLERY HAND SANITIZER- garrison brothers hand sanitizer liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 77293-0001-1, 77293-0001-2, 77293-0001-3 - Packager: Garrison Brothers Distillery
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated May 4, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
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:
- 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.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- 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.
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Active Ingredients & back label [OTC - ACTIVE INGREDIENT SECTION]
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
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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.
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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
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WHEN USING
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
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
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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:
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INGREDIENTS AND APPEARANCE
GARRISON BROTHERS DISTILLERY HAND SANITIZER
garrison brothers hand sanitizer liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77293-0001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 141.6 mL in 177 mL Inactive Ingredients Ingredient Name Strength GLYCEROL FORMAL (UNII: 3L7GR2604E) 2.57 mL in 177 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.23 mL in 177 mL WATER (UNII: 059QF0KO0R) 32.6 mL in 177 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77293-0001-3 1893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2020 2 NDC:77293-0001-2 750 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/30/2020 3 NDC:77293-0001-1 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2020 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 Business Operations Garrison Brothers Distillery 043768088 manufacture(77293-0001)