Active Ingredient(s)

Product: 78342-001 Alcohol 70% v/v. Purpose: Antiseptic

Product: 78342-002 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

Product 78342-001: glycerin, carbomer, triethanolamine, purified water USP

Product 78342-002: glycerin, carbomer, triethanolamine, purified water USP

Package Label - Principal Display Panel

500 mL NDC: 78342-001-01 500 ml 70

1000 mL NDC: 78342-001-02 1000L 70

20000 mL NDC: 78342-001-03 20 l 80

500 mL NDC: 78342-002-01 500 ml 80

1000 mL NDC: 78342-002-02 1000 ml 80

20000 mL NDC: 78342-002-03 20 litros 80

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78342-001
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 mL in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	3.5 mL in 100 mL
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)	1.5 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78342-001-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC:78342-001-03	20000 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/30/2020
3	NDC:78342-001-04	1000000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	03/30/2020
4	NDC:78342-001-02	1000 mL in 1 BOTTLE; 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

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78342-002
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	1.5 mL in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	6.6 mL in 100 mL
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)	0.4 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78342-002-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC:78342-002-03	20000 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/30/2020
3	NDC:78342-002-04	1000000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	03/30/2020
4	NDC:78342-002-02	1000 mL in 1 BOTTLE; 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 - Química Blantex, S.A. de C.V. (810400366)

Registrant - Química Blantex, S.A. de C.V. (810400366)

Name	Address	ID/FEI	Business Operations
Establishment
Química Blantex, S.A. de C.V.		810400366	manufacture(78342-001, 78342-002) , label(78342-001, 78342-002)