Label: SANI MOUSSE- alcohol aerosol, foam

  • 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 September 4, 2012

If you are a consumer or patient please visit this version.

  • Drug Facts Box OTC-Active Ingredients Section

    Ethyl Alcohol 62%

  • Drug Facts Box OTC-Purpose Section

    Antiseptic

  • INDICATIONS & USAGE

    for hand-washing to decrease bacteria on the skin, only when water is not available

  • Drug Facts Box OTC-Warnings Section

    Flammable, keep away from fire and flames

    For external use only


  • Drug Facts Box OTC-When Using Section

    do not get into eyes

    if contact occurs, rinse eyes thoroughly with water

  • Drug Facts Box OTC-Stop Use Section

    irritation and redness develop

  • Drug Facts Box OTC-Keep Out of Reach of Children Section

    If swallowed, get medical help or contact a Poison Control Center right away

  • Drug Facts Box OTC-Dosage & Administration Section

    Press valve once to deliver one squirt (about a quarter size) of foaming product into the palm of your hand

    rub hands together and allow to dry without wiping

  • Drug Facts Box OTC-Inactive Ingredients Section

    water, DEA-C8-18 perfluoroalkylethyl phosphate, cetearyl alcohol, polysorbate 65, dimethicone PEG-8 meadowfoamate, meadowfoamamidopropyl betaine, butane, propane, fragrance

  • Sani Mousse 4773 199g

    477307P4060.jpgimage of aerosol can

  • INGREDIENTS AND APPEARANCE
    SANI MOUSSE  
    alcohol aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53125-773
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPANE (UNII: T75W9911L6)  
    BUTANE (UNII: 6LV4FOR43R)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53125-773-25199 g in 1 CAN
    2NDC:53125-773-26454 g in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/04/2012
    Labeler - Superior Chemical Corporation (023335086)
    Registrant - ABC Compound Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Company of Texas, Inc.026219253manufacture(53125-773)