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) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

Glycerin (1.45% v/v).

Triethanolamine capryol glutamate (0.12% v/v).

Sterile distilled water or boiled cold water.

Carbomer 980 (0.86% v/v)

Aloe vera leaf (0.02% v/v)

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 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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.

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Other information

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

Inactive ingredients

glycerin, carbomer, triethanolamine caproyl glutamato, aloe vera leaf, purified water USP

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.

Package Label - Principal Display Panel

1000000 mL NDC 78359-001-08 1000000ml 250 ml

200000ml 3780ml

1000ml 500ml 125ml packing 60ml

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78359-001
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)	1.45 mL in 100 mL
WATER (UNII: 059QF0KO0R)
TRIETHANOLAMINE CAPROYL GLUTAMATE (UNII: 0F2FO57253)	0.12 mL in 100 mL
CARBOMER 980 (UNII: 4Q93RCW27E)	0.86 mL in 100 mL
ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517)	0.2 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78359-001-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC:78359-001-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC:78359-001-03	3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
4	NDC:78359-001-04	200000 mL in 1 DRUM; Type 0: Not a Combination Product	03/30/2020
5	NDC:78359-001-05	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
6	NDC:78359-001-06	125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
7	NDC:78359-001-07	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
8	NDC:78359-001-08	1000000 mL in 1 DRUM; Type 0: Not a Combination Product	03/30/2020

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

Labeler - Junior Chemical Products Care S.A. de C.V. (951578341)

Registrant - Junior Chemical Products Care S.A. de C.V. (951578341)

Name	Address	ID/FEI	Business Operations
Establishment
Junior Chemical Products Care S.A. de C.V.		951578341	manufacture(78359-001)