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, carbomer, Phenoxyethanol, Aminomethyl propanol, Aloe barbadensis, purified water USP

Package Label - Principal Display Panel

100 mL NDC: 75614-001-04 100ml

70% DISPOSABLE DISINFECTANT GEL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75614-001
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
ALOE (UNII: V5VD430YW9)	0.1 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	3 mL in 100 mL
CARBOMER 980 (UNII: 4Q93RCW27E)	0.4 mL in 100 mL
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.5 mL in 100 mL
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)	0.08 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75614-001-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2020
2	NDC:75614-001-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2020
3	NDC:75614-001-03	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2020
4	NDC:75614-001-05	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2020
5	NDC:75614-001-04	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2020
6	NDC:75614-001-06	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2020
7	NDC:75614-001-07	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2020
8	NDC:75614-001-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2020
9	NDC:75614-001-09	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2020
10	NDC:75614-001-10	400 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2020
11	NDC:75614-001-11	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2020
12	NDC:75614-001-12	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2020
13	NDC:75614-001-13	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2020
14	NDC:75614-001-14	3800 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2020
15	NDC:75614-001-15	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/31/2020

Labeler - Guangzhou Pinshang Biotechnology Development Co.,Ltd. (554530020)

Registrant - Guangzhou Pinshang Biotechnology Development Co.,Ltd. (554530020)

Name	Address	ID/FEI	Business Operations
Establishment
Guangzhou Pinshang Biotechnology Development Co.,Ltd.		554530020	manufacture(75614-001)

70% Hand Sanitizer-pinshang