Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic

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

Carbomer, triethanolamine, purified water USP

Package Label - Principal Display Panel

label

ANTISEPTIC 80% TOPICAL GEL HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75579-001
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
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75579-001-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC:75579-001-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC:75579-001-03	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC:75579-001-04	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC:75579-001-05	200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
6	NDC:75579-001-06	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
7	NDC:75579-001-07	500 mL in 1 BOTTLE, PUMP; 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 - Guangdong Genlese Cosmetics Co., Ltd. (543119089)

Name	Address	ID/FEI	Business Operations
Establishment
Guangdong Genlese Cosmetics CO., LTD.		543119089	manufacture(75579-001)