75% HAND SANITIZER- alcohol gel 
Shandong Retouch Wash And Sterilize Technology Co.,ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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75% Hand Sanitizer

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

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.

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

PDP

250 mL NDC:75532-001-02

PDP

500 mL NDC:75532-001-03

PDP

1000 mL NDC:75532-001-04

PDP4000 mL NDC:75532-001-05

PDP

75% HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75532-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75532-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
2NDC:75532-001-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
3NDC:75532-001-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
4NDC:75532-001-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
5NDC:75532-001-054000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/21/2020
Labeler - Shandong Retouch Wash And Sterilize Technology Co.,ltd. (529300365)
Establishment
NameAddressID/FEIBusiness Operations
Shandong Retouch Wash And Sterilize Technology Co.,ltd.529300365manufacture(75532-001)

Revised: 2/2023
Document Id: f463841d-aa9a-70b9-e053-2995a90a88f2
Set id: a3d95773-5f36-4f79-e053-2a95a90a131d
Version: 4
Effective Time: 20230210
 
Shandong Retouch Wash And Sterilize Technology Co.,ltd.