ZHUSHI HAND SANITIZER GEL- zhushi hand sanitizer gel gel 
Shandong Zhushi Pharmaceutical Group 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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Directions

1.Hygienic hands: Take an appropriate amount of hand disinfectant on the palm of the hand, rub your hands together to spread evenly on each partfor 1.0 min.
2.Surgical hands: After surgical hand washing, take an appropriateamount of hand disinfectant and apply evenly to each part of the hands, forearms and the lower 1/3 of the upper arm, and rub it carefully until the disinfectant is dry.the hands, forearms and lower thirds of the upper arms.

Uses

Hand disinfection. Decreases bacteria on the skin, surface of objects.

ethanol alcohol

N-propanol

Keep out of reach of children.

Antimicrobial

1.Disinfectant for external use, not oral
2.Keep out of reach of children.
3.Avoid using with antagonistic drugs.
4.Use with caution if allergic.
5.Keep away from fire and high temperature objects.
6.It is not suitable for the surface disinfection of fat-soluble objects or airdisinfection.

1.Tighten the bottle cap and store it after opening it for use.
2.Use within the validity period.
3.The product should be protected from light, sealed, andmoisture-proof, and stored in a cool, dry place.

label

ZHUSHI HAND SANITIZER GEL 
zhushi hand sanitizer gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56040-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL320 mL  in 500 mL
PROPYL ALCOHOL (UNII: 96F264O9SV) (PROPYL ALCOHOL - UNII:96F264O9SV) PROPYL ALCOHOL100 g  in 500 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56040-011-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product02/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/18/2021
Labeler - Shandong Zhushi Pharmaceutical Group Co., Ltd (560400484)
Establishment
NameAddressID/FEIBusiness Operations
Shandong Zhushi Pharmaceutical Group Co., Ltd560400484manufacture(56040-011)

Revised: 3/2022
Document Id: d9e8495c-6c4c-85e1-e053-2995a90a8e65
Set id: bb99f9a6-6432-5f65-e053-2a95a90ab52d
Version: 2
Effective Time: 20220310
 
Shandong Zhushi Pharmaceutical Group Co., Ltd