Americas Hand Sanitizer by Summitville Laboratories Inc a Div of Summitville Tiles / Summitville Laboratories Inc

Drug Details [pdf]

AMERICAS HAND SANITIZER- alcohol liquid
Summitville Laboratories Inc a Div of Summitville Tiles

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:

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.

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

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

236 mL NDC: 75648-108-10 bottle 8 oz bottle

236mL NDC: 75648-108-10 label 236 mL 8 oz label

AMERICAS HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75648-108
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 75648-108-10	236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/29/2020	05/15/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020	05/15/2022

Labeler - Summitville Laboratories Inc a Div of Summitville Tiles (195486790)

Name	Address	ID/FEI	Business Operations
Establishment
Summitville Laboratories Inc		195486790	relabel(75648-108) , repack(75648-108)

Revised: 8/2021

Document Id: c94ad129-2753-663a-e053-2995a90a07f9

Set id: a6cf0a39-d349-b1a3-e053-2a95a90aca37

Version: 2

Effective Time: 20210811

Summitville Lab