Label: CANPACO HAND SANITIZER- ethanol 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 August 4, 2020

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  • Active Ingredient(s)

    alcohol

  • Purpose

    • Antiseptic (skin) cleanser • Medicated (skin) cleanser • Antibacterial (skin)
    cleanser • active in destroying (harmful) bacteria to provide antiseptic
    cleansing • For personal hand hygiene to help prevent the spread of bacteria

  • Use

     Hand sanitizing to help reduce bacteria on the skin

  • Warnings

    For external use only.
    Flammable, keep away from fire or flame.
    When using this product, avoid contact with the eyes. In case of contact, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or redness appears and lasts.

  • KEEP OUT OF REACH OF CHILDREN

     Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    for external use only

  • INACTIVE INGREDIENT

    aqua, camellia sinensis leaf extract, carbomer, glycerin, ricinus communis (castor) seed oil, tocopheryl acetate, triethanolamine

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    CANPACO HAND SANITIZER 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76586-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76586-110-0130 mL in 1 POUCH; Type 0: Not a Combination Product06/12/2020
    2NDC:76586-110-023790 mL in 1 BOTTLE; Type 0: Not a Combination Product06/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/12/2020
    Labeler - HEALKINBIO CO. (694039685)
    Establishment
    NameAddressID/FEIBusiness Operations
    HEALKINBIO CO.694039685manufacture(76586-110)
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