Label: ANTIMICROBIAL HAND SANITIZER- 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 September 13, 2010

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  • Active Ingredient

    Ethyl Alcohol 66.5 percent

  • Purpose

    Antiseptic

  • Uses

    For handwashing to decrease bacteria on 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

    wet hands throughly with product allow to dry without wiping

    children under six should be supervised while using this product.

  • Inactive Ingredients

    aloe vera, carbomer, fragrance, purified water, triethanolamine

  • PRINCIPAL DISPLAY PANEL

    Drug Facts

    Drug Facts Label

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL HAND SANITIZER  
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51811-363(NDC:61010-111)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol39.33 mL  in 59.14 mL
    Inactive Ingredients
    Ingredient NameStrength
    Trolamine (UNII: 9O3K93S3TK)  
    Aloe (UNII: V5VD430YW9)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51811-363-2259.14 mL in 1 BOTTLE, PLASTIC
    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
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