Active Ingredient(s)

Alcohol 70% 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 15-30°C (59-86°F)
Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

Water, glycerin, carbomer, triethanolamine, isopropyl myristate, tocopheryl acetate (Vitamin E).

Package Label - Principal Display Panel

492 mL NDC: 76911-002-01

492 mL

918 mL NDC: 76911-002-02

918 mL

3450 mL 3.45L NDC:76911-002-03

3.45L

1900 mL 1.9L NDC:76911-002-04

1.9L

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76911-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
TROLAMINE (UNII: 9O3K93S3TK)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76911-002-01	492 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/15/2020
2	NDC:76911-002-02	918 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/15/2020
3	NDC:76911-002-03	3450 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/15/2020
4	NDC:76911-002-04	1900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/15/2020

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

Labeler - GRIFFITH FOODS, S.A. DE C.V. (951577057)

Registrant - GRIFFITH FOODS, S.A. DE C.V. (951577057)

Name	Address	ID/FEI	Business Operations
Establishment
GRIFFITH FOODS, S.A. DE C.V.		810552984	manufacture(76911-002) , repack(76911-002)

Name	Address	ID/FEI	Business Operations
Establishment
GRIFFITH FOODS, S.A. DE C.V.		951577057	manufacture(76911-002) , repack(76911-002)