This is a rub hand sanitizer (leave in product) which is intended to be used when soap and water are not available, and are left on and not rinsed off with water. It complies with the final rule on consumer antiseptic rubs, using alcohol in a percentage between 65 and 90%. The product is made with

Alcohol (ethanol) (70%, volume/volume (v/v)) in an aqueous solution denatured.
Glycerol (10% v/v).
Isopropyl alcohol (1.33% v/v).
Sterile distilled water or boiled cold water.
Carbomer 940 (0.25% m/v)
Polysorbate 20 (3.33% m/v)

The firm add only fragrance (0.002%) as an inactive ingredient, and realizes it may impact the quality and potency of the product.

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

Inactive ingredients

glycerin, isopropyl alcohol, carbopol 940, polysorbate 20, fragrance, purified water USP

Package Label - Principal Display Panel

1000 mL NDC: 76540-100-01 Hand Sanitizer

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76938-100
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
GLYCERIN (UNII: PDC6A3C0OX)	10 mL in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.25 g in 100 mL
WATER (UNII: 059QF0KO0R)
THIOGLYCOLIC ACID TRIETHANOLAMINE (UNII: JPH0S6Q77R)	1.336 mL in 100 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH)	3.33 g in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76938-100-02	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/30/2020

Labeler - GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION (951577051)

Registrant - GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION (951577051)

Name	Address	ID/FEI	Business Operations
Establishment
GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION		951577051	label(76938-100) , pack(76938-100) , manufacture(76938-100)