WATER-FREE ANTIBACTERIAL HAND SANITIZER- water-free antibacterial hand sanitizer gel 
Zhejiang Tengyu New Material 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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Store in a cool, dry, well ventilated place, away from light.

Pure Water

plant extract

Gycerinum

Triethanolamine

Carbomer

Take appropriate amount of this product for the hand,no need to wash and simply rub until dry.

Ethyl alcohol

keep out of reach of children

Disinfection
Sterilization
No Rinseing

1. This product is for external use and can not be taken orally.
2. 'This product is flammable. Keep away from fire.
3. Use sparingly for people with alcohol allergies.
4. Store in a cool, dry, well ventilated place, away from light.

label

WATER-FREE ANTIBACTERIAL HAND SANITIZER 
water-free antibacterial hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54983-011
Route of AdministrationEXTRACORPOREAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL177.75 mL  in 237 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54983-011-01237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/03/2020
Labeler - Zhejiang Tengyu New Material Technology Co., Ltd. (549825566)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Tengyu New Material Technology Co., Ltd.549825566manufacture(54983-011)

Revised: 4/2022
Document Id: dd36cd83-ce7a-17fe-e053-2995a90ad207
Set id: a73b9b02-d13f-44e3-e053-2995a90aa606
Version: 2
Effective Time: 20220421
 
Zhejiang Tengyu New Material Technology Co., Ltd.