Label: ZHUSHI HAND SANITIZER GEL gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated March 10, 2022

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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.

  • INACTIVE INGREDIENT

  • Uses

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

  • ACTIVE INGREDIENT

    ethanol alcohol

    N-propanol

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PURPOSE

    Antimicrobial

  • WARNINGS

    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.

  • STORAGE AND HANDLING

    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.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    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)