Label: 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 April 21, 2015

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  • Active Ingredient

    Ethyl Alcohol 65%

  • Purpose

    Antiseptic

  • Uses

    To decrease bacteria on the skin.

  • Warning

    For external use only.
    When using this product avoid contact with eyes.In case of contact flush eyes thoroughly with water.

    Flammable.
    Keep away from heat and flame.

    Stop use and consult a doctor
    if irritation and redness develop and persist for more than 72 hours.

  • Keep out of reach of children.

    If swallowed,get medical help or contact Poison Control Center right away

  • Directions

    ■ Wet hands with product and allow to dry without wiping.

    Children under 6 years of age should be supervised when using this product.

  • Other Information

    do not store above 104F (40C)
    may discolor certain fa surfaces.

  • Inactive Ingredient

    WATER,PHENOXYETHANOL,CARBOMER COPOLYMER TYPE A,SODIUM HYDRIDE,DMDM HYDANTOIN ,FD&C BLUE NO. 1,FD&C YELLOW NO. 5

  • PRINCIPAL DISPLAY PANEL

    phot of druglistingimage descriptionimage descriptionimage descriptionimage description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER  
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    SODIUM HYDRIDE (UNII: 23J3BHR95O)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    Colorred, pink, green, orange, purple, blueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51706-600-0129 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/17/2015
    Labeler - Landy International (545291775)
    Registrant - Landy International (545291775)
    Establishment
    NameAddressID/FEIBusiness Operations
    Landy International545291775manufacture(51706-600)
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