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

59 mL hand sanitizer bottle front 59 mL hand sanitizer bottle back 59 mL Hand Sanitizer gel label 59 mL NDC: 76800-102-01

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76800-102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	800 mL in 1000 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	14.5 mL in 1000 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.83 mL in 1000 mL
WATER (UNII: 059QF0KO0R)	179.15 mL in 1000 mL
CARBOMER 934 (UNII: Z135WT9208)	2.52 mL in 1000 mL
AMINOMETHYLPROPANOL (PERFLUORO-C6-C12 ETHYL)PHOSPHATE (UNII: QCD5R22RNT)	3 mL in 1000 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76800-102-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/22/2020

Labeler - Fuego Envasado SA de CV (812932655)

Registrant - Fuego Envasado SA de CV (812932655)

Name	Address	ID/FEI	Business Operations
Establishment
Fuego Envasado, S.A. de C.V.		812932655	manufacture(76800-102)