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 June 14, 2012

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  • Active Ingredient

    Ethyl Alcohol 63%
  • Purpose

    Antiseptic

  • Uses

    To decrease bacteria on the skin.
  • Warning

    For external use only.

    Flammable.
    Keep away from heat and flame.

    When using this product
    ■ Avoid contact with eyes. If contact occurs, flush eyes with water.
    ■ Avoid contact with broken skin.

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

    Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    ■ Wet hands with product and allow to dry without wiping.
    ■  Not recommended for infants.
  • Other Information

    ■ Store at 68 o to 77 oF (20 o to 25 oc).
    ■ Do not store above 105 oF.
    ■ May discolor some fabrics.
    ■ Harmful to wood finishes and plastics.

    Inactive Ingredient

    Alcohol Denat., Water, Propylene Glycol, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Jojoba Esters, Tocopheryl Acetate, Blue 1(CI 42090), Red 33(CI 17200), Red 4(CI 14700).
    Yellow 5(CI 19140),
  • PRINCIPAL DISPLAY PANEL

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    phot of druglisting

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER  
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LACTOSE (UNII: J2B2A4N98G)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Colorred, pink, green, orange, purple, blueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51706-500-0129 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/14/2012
    Labeler - Landy International (545291775)
    Registrant - Wal-Mart Stores, Inc. (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Landy International545291775manufacture(51706-500)
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