Label: MUELLER INSTANT HAND SANITIZER- alcohol liquid

  • 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 December 11, 2014

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

    Ethyl Alcohol 62%

    Antiseptic handwash

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

    Use for handwashing to decrease bacteria on the skin.  recommended for repeated use

    For external use only,  Flammable, keep away from fire or flame.  When using this product do no tuse in the eyes.  discontinue use if irritation and redness develop.  If condition persists for more than 72 hours consult a doctor.

    Directions.  Wer hands thoroughly with product and allow to dry without wiping.

    Other information.  place a quarter size amount into one hand, spread over both hands to wrist and rub into skin until dry.  Store at 59 to 77 degrees Farenheit (15 to 25 degrees Celsius)

    Acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, dl-alpha tocopheryl acetate, fragrance, PEG-60 almond glycerides, propylene glycol, purified water, triisopropanolamine

  • PRINCIPAL DISPLAY PANEL

    drug facts panel

  • INGREDIENTS AND APPEARANCE
    MUELLER INSTANT HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52564-460
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52564-460-04118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/05/2010
    Labeler - Mueller Sports Medicine, Inc. (006426316)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies, LLC155522589manufacture(52564-460)
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