Label: ANTI-BACTERIAL HAND GEL MANGO MADNESS- ethyl alcohol 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 July 10, 2013

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  • ACTIVE INGREDIENT

    Active Ingredient
    Alcohol 60%
  • PURPOSE

    Purpose
    Antiseptic
  • INDICATIONS & USAGE

    Use: Decreases bacteria on hands.

  • WARNINGS

    Warning: For external use only. Flammable.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. 

  • DOSAGE & ADMINISTRATION

    Directions: Rub a dime sized drop into hands                                                                                                                                                          


  • PRINCIPAL DISPLAY PANEL

    image of bottle label
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:
    Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance, Tocopheryl Acetate, Lactose, Microcrystalline Cellulose, FD&C Red NO.4, FD&C Yellow NO.5

  • INGREDIENTS AND APPEARANCE
    ANTI-BACTERIAL HAND GEL MANGO MADNESS 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59045-1008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol60 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    ALOE (UNII: V5VD430YW9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LACTOSE (UNII: J2B2A4N98G)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59045-1008-129 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/10/2013
    Labeler - The Man Can, LLC (063578571)
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