Label: ANTIBACTERIAL PROTECTIVE HAND- chlorhexidine gluconate lotion

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated February 1, 2013

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  • Active Ingredient

    Chlorhexidine Gluconate 0.5%

  • Purpose

    Antiseptic

  • Uses

    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 or near the eyes, in case of exposure rinse eyes throughly with water.

    Do not use if you have preexisting rash condition.

  • STOP USE

    Stop use and ask a doctor if irritation, redness or rash appear.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away.

  • Directions

    Rub onto hands, as needed.

  • Inactive Ingredients

    aloe barbadensis, aroma, carthamus tinctorius (safflower oleosomes), cellulose gum, cetyl alcohol, glycerin, glycerol stearate, panthenol, pvp, red 40 (ci 16035), tocopherol acetate, water, yellow 5 (CI 19140), zinc oxide

  • PRINCIPAL DISPLAY PANEL

    Drug Facts

    MonarchHLHalf

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL PROTECTIVE HAND 
    chlorhexidine gluconate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51811-066
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE.07075 g  in 14.15 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POVIDONE K30 (UNII: U725QWY32X)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51811-066-9914.15 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2013
    Labeler - Hanover Pen Corp dba HPC Global (003022670)
    Registrant - Hanover Pen Corp dba HPC Global (003022670)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hanover Pen Corp dba HPC Global003022670repack(51811-066) , label(51811-066)
    Establishment
    NameAddressID/FEIBusiness Operations
    Micrylium Laboratories252529185manufacture(51811-066)
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