Label: ALCOHOL gel

  • Category: HUMAN OTC DRUG LABEL

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, 2014

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  • INACTIVE INGREDIENT

    Inactive Ingredients

    carbomer 940, glycerin,

    propylene glycol, red 33,

    tocopheryl acetate,

    triethonamoline, water

  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol, 65 % v/v

  • PURPOSE

    Purpose    Antimicrobial

  • WARNINGS

    Warnings

    For external use only

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed,

    get medical help or contact a Poison

    Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions. Put a dime sized

    drop onto hands and rub

    briskly until dry.

  • INDICATIONS & USAGE

    Uses.  hand sanitizer to help

    reduce bacteria on skin

  • DO NOT USE

    Do not use in or near the eyes.

    In case of contact, rinse eyes

    thoroughly with water.

  • OTHER SAFETY INFORMATION

    Flammable. Keep away from

    fire or flame

  • STOP USE

    Stop use and ask a doctor

    if irritation, excessive redness

    or rash develops

  • STORAGE AND HANDLING

    Other information

    Store below 110 F ( 43 C)

  • PRINCIPAL DISPLAY PANEL

    copy of label
  • INGREDIENTS AND APPEARANCE
    ALCOHOL  
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43473-805
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43473-805-0129 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/01/2014
    Labeler - Nantong Health & Beyond Hygienic Products Inc. (421280161)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Health & Beyond Hygienic Products Inc.421280161manufacture(43473-805)
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