Label: HYDRATING INSTANT 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 February 1, 2013

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  • Active Ingredient

    Ethyl Alcohol 70 percent

  • Purpose

    Antimicrobial

  • Uses

    Cleansing gel for hands that need frequent care.

    Decrease bacteria on skin.

  • 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

    Apply approximately 3ml on palm and rub hands for 30 seconds.

    Rinsing is not required.

  • Inactive Ingredients

    aloe barbadensis, aroma, blue 1 (CI 42090), carbomer, cetyl alcohol, glycerin, panthenol, tocopherol acetate, triethanolamine, water, yellow 5 (CI 19140)

  • PRINCIPAL DISPLAY PANEL

    Drug Facts

    Monarch HS Pouch

  • INGREDIENTS AND APPEARANCE
    HYDRATING INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51811-659
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL.6329 mL  in .9242 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51811-659-00.9242 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/01/2013
    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(51811-659) , label(51811-659)
    Establishment
    NameAddressID/FEIBusiness Operations
    Micrylium Laboratories252529185manufacture(51811-659)
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