Label: ANTIMICROBIAL HAND SANITIZER- alcohol gel 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 4, 2020

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  • Active Indgredient

    Ethyl Alcohol 70%

    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 in the eyes, if this happens rinse thoroughly with water.

    Stop use and ask a doctor if irritation and redness develop 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 thoroughly with product
    • allow to dry without wiping
    • children under six should be supervised while using this product.
  • Inactive Ingredients

    aloe vera, carbomer, D&C green #5, D&C yellow #10, fragrance, purified water, triethanolamine

  • SPL UNCLASSIFIED SECTION

    Fresh - Lot# ****

    Packaged by HPC Global

    Hanover PA, 17331

    Made in USA

  • PRINCIPAL DISPLAY PANEL

    Antimicrobial Hand Sanitizer Gel

    16 FL OZ

    Drug Facts

    Drug Facts

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL HAND SANITIZER 
    alcohol gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51811-745
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL165.9 mL  in 237 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51811-745-10237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/13/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/13/2010
    Labeler - Hanover Pen Corp dba HPC Global (003022670)
    Registrant - Robert Houghland (003022670)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hanover Pen Corp dba HPC Global003022670relabel(51811-745) , repack(51811-745)
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