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

purified water USP, glycerin, carbomer, triethanolamine.

Package Label - Principal Display Panel

29.5 mL NDC: 77231-010-01

59 mL NDC: 77231-010-02

237 mL NDC: 77231-010-03 237

500 mL NDC: 77231-010-04 500mL

946 mL NDC: 77231-010-05

3785 mL NDC: 77231-010-06 galon

200000 mL NDC: 77231-010-08 200L

1000000 mL NDC: 77231-010-07 1000L

20000000 mL NDC: 77231-010-09 20000

2000 mL NDC: 77231-010-10

PDP 2L

8000 mL NDC: 77231-010-11

PDP 4-8L

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77231-010
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
CARBOMER 940 (UNII: 4Q93RCW27E)	0.4 g in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.35 g in 100 mL
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77231-010-06	3785.41 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/30/2020
2	NDC:77231-010-01	29.57 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	03/30/2020
3	NDC:77231-010-02	59.15 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC:77231-010-03	236.59 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC:77231-010-04	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC:77231-010-05	946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC:77231-010-08	200000 mL in 1 DRUM; Type 0: Not a Combination Product	03/30/2020
8	NDC:77231-010-07	1000000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	03/30/2020
9	NDC:77231-010-09	20000000 mL in 1 TANK; Type 0: Not a Combination Product	03/30/2020
10	NDC:77231-010-10	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/02/2020
11	NDC:77231-010-11	8000 mL in 1 BOX; Type 0: Not a Combination Product	07/02/2020

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

Labeler - GIA EVOLUTION SA DE CV (951577293)

Registrant - GIA EVOLUTION SA DE CV (951577293)

Name	Address	ID/FEI	Business Operations
Establishment
GIA EVOLUTION SA DE CV		951577293	manufacture(77231-010) , pack(77231-010) , label(77231-010)