SANI (ALCOHOL) GEL [AIS SPECIALTY PRODUCTS, INC.]

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SANI (ALCOHOL) GEL [AIS SPECIALTY PRODUCTS, INC.]
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NDC 50522-221-05, 50522-221-17, 50522-221-24, 50522-221-28
Set ID 573360f2-d5f6-452e-89d0-17766534584a
Category HUMAN OTC DRUG LABEL
Packager AIS Specialty Products, Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Drug Facts Box OTC-Active Ingredient Section

    Ethyl Alcohol 62%

  • Drug Facts Box OTC-Purpose Section

    Antiseptic

  • Drug Facts Box OTC-Indications & Usage Section

    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

    wet hands thoroughly with product and allow to dry without wiping

  • Drug Facts Box OTC-Inactive Ingredient Section

    water, diisopropylamine, carbomer, propylene glycol, DMDM hydantoin, tocopheryl acetate, aloe barbadensis

  • Sani-Gel 6605 5oz

    product label

    Sani-Gel  5oz  

  • INGREDIENTS AND APPEARANCE
    SANI 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50522-221
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    DIISOPROPYLAMINE (UNII: BR9JLI40NO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50522-221-17532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/2012
    2NDC:50522-221-24118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/2012
    3NDC:50522-221-05540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/2012
    4NDC:50522-221-28149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/24/2012
    Labeler - AIS Specialty Products, Inc. (003662885)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture(50522-221)
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