Label: HAN-I-SIZE- alcohol gel

  • NDC Code(s): 63533-221-14, 63533-221-28
  • Packager: Momar Incorporated
  • 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 26, 2018

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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

  • Han-I-Size 6605 5 oz

    product label

    Han-I-Size 5 oz bottle 

  • INGREDIENTS AND APPEARANCE
    HAN-I-SIZE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63533-221
    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:63533-221-143785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2005
    2NDC:63533-221-28149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/01/2005
    Labeler - Momar Incorporated (003266616)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture(63533-221)
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