Label: 75% ALCOHOL INSTANT HAND SANITIZER GEL- 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 April 5, 2020

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  • PURPOSE

    Effective disinfection reached 99.9%

  • ACTIVE INGREDIENT

    Alcohol

  • INDICATIONS & USAGE

    SUITABLE FOR HAND SURFACE CLEANING DISINFECTION

  • KEEP OUT OF REACH OF CHILDREN

    keep out of children

  • WARNINGS

    1.THS PRODUCT 5 FOR EXTERNAL USE OF DISPOSABLE HAND DISINFECTION CONDENSATION, NOT FOR INTERNAL USE KEEP OUTOF REACHOF CHILDREN.
    2. THS PRODUCT SLGHTLY RRTATES THE DAMAGEDSKON.
    3.STORE IN SEALED, COOL, DRY PLACE.AVOID THE SUN AND INFLAMMBLE DURING TRANSPORTATION.

  • DOSAGE & ADMINISTRATION

    LSAGE TAKE APPROPRIATE AMOUNT OF THIS PRODUCT ON THEPAIMAND THEN KNEADWPEPALMS,BACXOFHANDS, FNGERS. BACK OF RNGERS, THUMB.FINGERIPSANDWRISTS, UNIL HANDS AREDRY.

  • INACTIVE INGREDIENT

    Deionized water
    Glycerol
    Carbopol 940
    Triethanolamine

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL INSTANT HAND SANITIZER GEL 
    sanitizer gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56084-001
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL40.8 mL  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    5-NORBORNENE-2-METHYLOLACRYLATE (UNII: YR5K75EW22)  
    Product Characteristics
    Colorwhite (transparent) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56084-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/05/2020
    Labeler - ZHEJIANG RIFESHOW COSMETICS CO.,LTD (560843477)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZHEJIANG RIFESHOW COSMETICS CO.,LTD560843477manufacture(56084-001)
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