Label: LUCKY ANTIBACTERIAL HAND SOAP SUPERSOFT- triclosan liquid

  • 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 18, 2010

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  • Active Ingredient

    Triclosan 0.1%

  • Purpose

    Antibacterial

  • Uses

    For handwashing to decrease bacteria on the skin. Recommended for repeated use.
  • Warnings

    For external use only

  • When using this product

    avoid contact with eyes. In case of eye contact immediately flush eyes with water, call a doctor. Avoid contact with broken skin.
    Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.
  • Keep out of reach of children

    Children can only use this product with adult supervision. Do not drink. Not edible. In case of accidental ingestion seek professional assistance or contact Poison Control Center immediately.

  • Directions

    Wet hands. Apply palmful to hands. Scrub thoroughly. Rinse. Recommended for repeated use

  • INACTIVE INGREDIENT

    Water, Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Betaine, Cocamide DEA, Polyquaternium-7, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium EDTA, Benzophenone-4, Citric Acid, Alphatocopherol Acetate (Vitamin E), FDC Yellow No. 5

  • PRINCIPAL DISPLAY PANEL

    Package Label
    image of package label

  • INGREDIENTS AND APPEARANCE
    LUCKY ANTIBACTERIAL HAND SOAP  SUPERSOFT
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-164
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 900 KD) (UNII: B70CUU14M9)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    BENZOPHENONE (UNII: 701M4TTV9O)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20276-164-75222 mL in 1 BOTTLE, SPRAY
    2NDC:20276-164-08237 mL in 1 BOTTLE, PUMP
    3NDC:20276-164-09266 mL in 1 BOTTLE, PUMP
    4NDC:20276-164-10296 mL in 1 BOTTLE, PUMP
    5NDC:20276-164-11333 mL in 1 BOTTLE, PUMP
    6NDC:20276-164-12355 mL in 1 BOTTLE, PUMP
    7NDC:20276-164-13400 mL in 1 BOTTLE, PUMP
    8NDC:20276-164-14414 mL in 1 BOTTLE, PUMP
    9NDC:20276-164-15444 mL in 1 BOTTLE, PUMP
    10NDC:20276-164-16500 mL in 1 BOTTLE, PUMP
    11NDC:20276-164-32946 mL in 1 BOTTLE, PLASTIC
    12NDC:20276-164-401183 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33309/01/2010
    Labeler - Delta Brands Inc (102672008)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi Daily Chemical Co. Ltd.529047265manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Delta Dis Ticaret A.S.643703853manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Primo Ambalaj ve Kimya Sanayi ve Ticaret A S 356694526manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil566220234manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Marmara Temizlik Maddeleri Sanayi Ve Ticaret Ltd STI356082250manufacture
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