DISPOSABLE SANITIZING GEL- disposable sanitizing gel gel 
Wuxi Jianuo Intelligent Industrial 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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Disposable Sanitizing Gel

Active Ingredient

Alcohol 80%v/v

​Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.For use when soap and water are not available.

Warning

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

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.

Other information

Store between 15-30℃(59-86°F) .

Avoid freezing and excessive heat above 40℃(104°F).

Inactive ingredients

glycerin, hydrogen peroxide,purified water USP

Package Label - Principal Display Panel

500 ml label

DISPOSABLE SANITIZING GEL 
disposable sanitizing gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75211-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75211-001-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/26/2020
Labeler - Wuxi Jianuo Intelligent Industrial Technology Co., Ltd. (554529553)
Registrant - Wuxi Jianuo Intelligent Industrial Technology Co., Ltd. (554529553)
Establishment
NameAddressID/FEIBusiness Operations
Wuxi Jianuo Intelligent Industrial Technology Co., Ltd.554529553manufacture(75211-001)

Revised: 4/2020
Document Id: a43214e2-4f01-0d6e-e053-2a95a90a1981
Set id: a432fb30-aaba-a407-e053-2995a90a5acf
Version: 1
Effective Time: 20200426
 
Wuxi Jianuo Intelligent Industrial Technology Co., Ltd.