Label: LUCKY ANTIBACTERIAL DEODORANT- triclosan soap

  • 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 April 8, 2013

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  • ACTIVE INGREDIENT

    Active ingredient
    Triclosan 0.2%

  • PURPOSE

    Purpose
    Antibacterial

  • INDICATIONS & USAGE

    Uses  • for hand washing to decrease bacteria on the skin.

  • WARNINGS

    Warnings  • For external use only

  • WHEN USING

    When using this product • avoid contact with eyes • in case of eye contact, flush with water.

  • STOP USE

    If irritation and redness develops, stop use and ask a doctor

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed get medical help or contact a Poison Control Center right away. Keep out of the reach of children.

  • DOSAGE & ADMINISTRATION

    Directions •wet bar with water • lather vigorously and wash skin • rinse and dry thoroughly.

  • INACTIVE INGREDIENT

    Inactive ingredients sodium palm kernelate, sodium palmate, water, fragrance, glycerin, sodium chloride, tetrasodium EDTA, titanium dioxide, FDC yellow no. 5, FDC yellow no. 6

  • PRINCIPAL DISPLAY PANEL

    image of package label

  • INGREDIENTS AND APPEARANCE
    LUCKY  ANTIBACTERIAL DEODORANT
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    SODIUM PALMITATE (UNII: JQ43KP6296)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20276-050-3090 g in 1 BOX
    2NDC:20276-050-35100 g in 1 BOX
    3NDC:20276-050-44125 g in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/21/2012
    Labeler - Delta Brands Inc. (102672008)
    Establishment
    NameAddressID/FEIBusiness Operations
    IFFCO KISISEL BAKIM URUNLERI SANAYI VE TICARET AS502658435manufacture(20276-050)
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