Label: ALOE VERA HAND SANITIZER HANDSANTTIZER- handsanttizer 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 30, 2020

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  • WARNINGS

    Flammable. Keep away from fire or flame.

  • INDICATIONS & USAGE

    Directions. Put enough product in your palm to cover your hands completely. Rub hands together, covering all surfaces for approx. 25 seconds or until your hands are dry. Children under 6 years of age should be supervised when using this product.

  • DOSAGE & ADMINISTRATION

    Store at 60'°F to 77°F (16°C to 25°C).

    May discolor certain fabrics or surfaces.

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • INACTIVE INGREDIENT

    Water, Glycerin, Carbomer, Triethanolamine.

    Fragrance(Parfum) Lemon, Aloe Barbadensis Leaf Extract

  • ACTIVE INGREDIENT

    Ethyl Alcohol 65.00%..

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ALOE VERA HAND SANITIZER  HANDSANTTIZER
    handsanttizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67984-001
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL58.5 mL  in 90 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LEMON (UNII: 24RS0A988O)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code seasonguard
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67984-001-0190 mL in 1 BOTTLE; Type 0: Not a Combination Product03/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/25/2020
    Labeler - XIAMEN EASEPAL ENTERPRISES LIMITED (679849096)
    Establishment
    NameAddressID/FEIBusiness Operations
    XIAMEN EASEPAL ENTERPRISES LIMITED679849096manufacture(67984-001)
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