Label: ANTISEPTIC HAND GEL WITH ALOE- 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 February 25, 2010

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  • Drug Facts Box OTC-Active Ingredient Section

    Ethyl Alcohol 62%

  • Drug Facts Box OTC-Purpose Section

    Antimicrobial

  • Drug Facts Box OTC-Indications & Usage Section

    to sanitize hands without requiring water or a rinse

    kills 99.9% of most common bacteria in 15 seconds

  • Drug Facts Box OTC-Warnings Section

    FLAMMABLE

    For external use only

  • Drug Facts Box OTC-When Using Section

    do not use near heat or open flame

    do not use in or near eyes

    discontinue use if irritation and redness develop

    do not use on deep or puncture wounds, consult your doctor

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

    In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

  • Drug Facts Box OTC-Dosage & Administration Section

    apply gel liberally to unsoiled hands and rub in thoroughly

    allow to dry without wiping or rinsing

  • Drug Facts Box OTC-General Precautions Section

    store at room temperature

  • Drug Facts Box OTC-Inactive Ingredient Section

    Water, Aloe Vera Gel, Carbomer, Diisopropylamine,
    Glycerin, Isopropyl Myristate, Fragrance, Phenoxyethanol, Tocopheryl Acetate, Acid Blue 9

  • Antiseptic Hand Gel with Aloe 6711 18oz

    671118P6318.jpg Antiseptic Hand Gel with Aloe 18ozimage of bottle label

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC HAND GEL WITH ALOE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68345-711
    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
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    DIISOPROPYLAMINE (UNII: BR9JLI40NO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68345-711-17510 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33307/31/2009
    Labeler - PSS World Medical, Inc. (101822682)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture
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