Label: INSTANT HAND SANITIZER- hand sanitizer 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 24, 2020

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  • DOSAGE & ADMINISTRATION

    Do not place this product in high temperature or direct sunlight.

  • INACTIVE INGREDIENT

    water

    propylene glycol

    glycerin

    carbomer triethanolamine

  • INDICATIONS & USAGE

    when you wash your hands,squeeze some of the gel into your hands and rub it with your hand unitl are dry.

  • ACTIVE INGREDIENT

    ALCOHOL

  • KEEP OUT OF REACH OF CHILDREN

    keep out of children

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    Do not place this product in high temperature or direct sunlight.keep out of children

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54708-002
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL68.4 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TRIETHANOLAMINE CACODYLATE (UNII: M49TH27L7A)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE (UNII: AUG1H506LY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54708-002-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/17/2020
    Labeler - Venus Skin & Hair Laboratory Ltd. (547075720)
    Establishment
    NameAddressID/FEIBusiness Operations
    Venus Skin & Hair Laboratory Ltd.547075720manufacture(54708-002)