Label: ANTIMICROBIAL HAND SANITIZER- alcohol spray

  • 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 13, 2010

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  • Active Ingredient

    Ethyl Alcohol 62 percent

  • Purpose

    Antiseptic

  • Uses

    To decrease bacteria on the skin.

    Recommended for repeated use.

  • WARNINGS

    For external use only.

    Flammable, keep away from fire or flame.

  • DO NOT USE

    Do not use in the eyes, if this happens rinse thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation of redness develops and persists for more than 72 hours.

  • Keep out of reach of children.

    If ingested get medical help or contact a Poison Control Center right away.

  • Directions

    spray hands throughly with product allow to dry without wiping

    children under six should be supervised while using this product.

  • Inactive Ingredients

    Water (aqua), Glycerin, Propylene Glycol, Tocopheryl Acetate, Isopropyl Myristate, Fragrance

  • PRINCIPAL DISPLAY PANEL

    Drug Facts

    Image of Drug Facts Label

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL HAND SANITIZER  
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51811-352
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol5.58 mL  in 9 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51811-352-109 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/13/2010
    Labeler - Hanover Pen Corp dba HPC Global (003022670)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hanover Pen Corp dba HPC Global003022670repack, label
    Establishment
    NameAddressID/FEIBusiness Operations
    Bell Pharmaceuticals140653770manufacture
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