Label: CALLICOS HAND GEL SANITIZER- 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 August 30, 2020

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  • ACTIVE INGREDIENT

    ethyl alcohol 62% v/v

  • Purpose

    Antiseptic

  • Use

    to decrease bacteria on the skin

    recommended for repeated use

    for use when soap and water are not available

  • Warnings

    For external use only.
    Flammable, keep away from fire or flame.

  • 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

    place enough product on hands to cover all surfaces

    rub hands together until dry

    supervise children under 6 years of age when using this product to avoid swallowing

  • INACTIVE INGREDIENT

    water, carbomer, triethaqnolamine, peg-60 hydrogenated castor oil, camellia sinensis leaf extract, glycerin, tocopheryl acetate

  • WHEN USING

    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.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    CALLICOS HAND GEL SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76586-112
    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)  
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76586-112-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    2NDC:76586-112-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/07/2020
    Labeler - HEALKINBIO CO. (694039685)
    Establishment
    NameAddressID/FEIBusiness Operations
    HEALKINBIO CO.694039685manufacture(76586-112)
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