HAND SANITIZER (ALCOHOL) GEL [HANOVER PEN CORP DBA HPC GLOBAL]

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HAND SANITIZER (ALCOHOL) GEL [HANOVER PEN CORP DBA HPC GLOBAL]
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NDC 51811-376-16
Set ID 2b3f98a5-2cab-4316-8c59-0ea047da2f43
Category HUMAN OTC DRUG LABEL
Packager Hanover Pen Corp dba HPC Global
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Active Ingredient

    Ethyl Alcohol 66.5 percent

  • Purpose

    Antiseptic

  • Uses

    For handwashing to 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 the eyes, if this happens rinse thoroughly with water.

  • Stop use and ask a doctor

    Stop use and ask a doctor if irritation of redness develops and persists for more than 72 hours.

  • Keep out of reach of children

    If ingested get medical help or contact a Poison Control Center right away.

  • Directions

    wet hands throughly with product allow to dry without wiping

    children under six should be supervised while using this product.

  • Inactive Ingredients

    aloe vera, carbomer, D and C number 5, D and C yellow number 10, fragrance, purified water, triethanolamine

  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL

    Front Label

    NDC 51811-376-16

    Hand Sanitizer - Fresh

    16 FL OZ (473ML)

    Back Label (Drug Facts)

    Hand Sanitizer - Fresh

    Distributed by

    HPC Global, Hanover PA, 17331

    Made in USA


    Image Drug Facts Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51811-376
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol.665 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Trolamine (UNII: 9O3K93S3TK)  
    Aloe (UNII: V5VD430YW9)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51811-376-16473 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/01/2012
    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, label
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262manufacture
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