Label: AMERIGEL HAND SANITIZER- ethyl alcohol 70% 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 June 22, 2020

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  • Active Ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    For handwashing to decrease bacteria on skin when soap and water are not available.

  • Warnings

    For External Use only. Flammable. Keep away from heat or flame.

  • Do not use


    In children less than 2 months of age. On open skin wounds.

  • When using this product

    Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • ­­­­­­­­­­­­­­­­­­­Stop use and ask a doctor.

    If irritation or rash occurs. These may be signs of a serious condition.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • ­­­­­­­­­­­­­­­­­­­­­Directions

    Wet hands thoroughly with product. Rub hands together briskly until dry. Supervise children under 6 years of age when using this product.

  • Other Information

    Store below 110F (43C)

  • Inactive Ingredients

    Water, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Propylene Glycol, PEG-8 Dimethicone, Triisopropanolamine, Linalool, FD&C Blue #1

  • Amerigel Hand Sanitizer

    labellabel

  • INGREDIENTS AND APPEARANCE
    AMERIGEL HAND SANITIZER 
    ethyl alcohol 70% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61470-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL123.9 mL  in 177 mL
    Inactive Ingredients
    Ingredient NameStrength
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
    PROPYLENE GLYCOL BUTYL ETHER (UNII: 6X8776AP5Z)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61470-001-12177 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    Labeler - Amerx Health Care Corp (836425694)
    Registrant - Amerx Health Care Corp (836425694)
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