Label: ANTIBACTERIAL HAND SOAP- triclosan liquid

  • Contains inactivated NDC Code(s)
    NDC Code(s):     20276-165-08, 20276-165-09, 20276-165-10, 20276-165-11, view more
    20276-165-12, 20276-165-13, 20276-165-14, 20276-165-15, 20276-165-16, 20276-165-20, 20276-165-24, 20276-165-32, 20276-165-33, 20276-165-35, 20276-165-48, 20276-165-64, 20276-165-75
  • Packager: Delta Brands Inc
  • 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 September 20, 2011

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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 should 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

    Deionized Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine,Sodium Chloride, Cocamide DEA, Glycerin*, Polyquaternium-7*, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Citric Acid, Benzophenone-4, FDC Yellow No. 6, DC Red No 33
    *May contain one or more of these ingredients

  • PRINCIPAL DISPLAY PANEL

    Product Label
    image of package label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SOAP 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-165
    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)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20276-165-75221 mL in 1 BOTTLE, PUMP
    2NDC:20276-165-08237 mL in 1 BOTTLE, PUMP
    3NDC:20276-165-09266 mL in 1 BOTTLE, PUMP
    4NDC:20276-165-10296 mL in 1 BOTTLE, PUMP
    5NDC:20276-165-11325 mL in 1 BOTTLE, PUMP
    6NDC:20276-165-12355 mL in 1 BOTTLE, PUMP
    7NDC:20276-165-13384 mL in 1 BOTTLE, PUMP
    8NDC:20276-165-35400 mL in 1 BOTTLE, PUMP
    9NDC:20276-165-14414 mL in 1 BOTTLE, PLASTIC
    10NDC:20276-165-15444 mL in 1 BOTTLE, PLASTIC
    11NDC:20276-165-16500 mL in 1 BOTTLE, PUMP
    12NDC:20276-165-20592 mL in 1 BOTTLE, PLASTIC
    13NDC:20276-165-24710 mL in 1 BOTTLE, PLASTIC
    14NDC:20276-165-32946 mL in 1 BOTTLE, PLASTIC
    15NDC:20276-165-331000 mL in 1 BOTTLE, PLASTIC
    16NDC:20276-165-481420 mL in 1 BOTTLE, PLASTIC
    17NDC:20276-165-641890 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/30/2011
    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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