Label: HAND SANITIZER- alcohol lotion

  • 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 1, 2020

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  • Active ingredient

    Ethyl alcohol 62%

    Purpose

    Antiseptic

  • Use

    for handwashing to decrease bacteria on the skin.

  • Warnings

    for external use only-hands

    Flammable.

    Keep away from heat and flame.

    When using this product

    • keep out of eyes.  In case of contact with eyes, flush thoroughly with water
    • avoid contact with  broken skin
    • do not inhale or ingest

    Stop use and ask a doctor if

    skin irritation develops

    Keep out of reach of children.

    if swallowed get medical help or contact a Poison control Center right away.

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping
    • for children under 6, use only under adult supervision
    • not recommended for infants
  • Other information

    • do not store above 105⁰ F
    • may discolor some fabrics
    • harmful to wood finishes ad plastics
  • Inactive ingredients

    benzophenone-4, carbomer, D+C orange no. 4, fragrance, glycerin, isopropyl alcohol, isopropyl myristate, propylene glycol, tocopheryl acetate, water

  • PRINCIPAL DISPLAY PANEL

    NDC 11344-022-03

    Totally Tangerine

    germblaster

    Hand Sanitizer

    germ-X

    KILLS 99.99% OF GERMS

    2.5 FL OZ (73 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-944
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL.073 mL  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11344-944-18.073 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/19/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/19/2005
    Labeler - Vi-Jon, Inc (150931459)
    Registrant - Vi-Jon (150931459)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon150931459manufacture(11344-944)