75% HAND SANITIZER- alcohol gel

75% Hand Sanitizer by

Drug Labeling and Warnings

75% Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Shandong Retouch Wash And Sterilize Technology Co.,ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 75% 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 or if allergy to alcohol

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

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

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

Directions

Take 3mL of the product to moisten your hands and rub for 1 min until the liquid covers your hands, wait until dry, and no need to wash with water.

Other information

Store in a cool, dry place (below 86F). Keep sealed.

Supervise children under 6 years of age when using this product to avoid swallowing.

Inactive ingredients

Carbomer, Triethanolamine, Emollients, Essence and purified water

Package Label - Principal Display Panel

60 mL NDC: 75532-001-01

250 mL NDC: 75532-001-02

500 mL NDC: 75532-001-03

1000 mL NDC: 75532-001-04

4000 mL NDC: 75532-001-05

INGREDIENTS AND APPEARANCE

75% HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75532-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75532-001-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/21/2020
2	NDC: 75532-001-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/21/2020
3	NDC: 75532-001-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/21/2020
4	NDC: 75532-001-04	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/21/2020
5	NDC: 75532-001-05	4000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/21/2020

Labeler - Shandong Retouch Wash And Sterilize Technology Co.,ltd. (529300365)

Establishment
Name	Address	ID/FEI	Business Operations
Shandong Retouch Wash And Sterilize Technology Co.,ltd.		529300365	manufacture(75532-001)