Label: ANTIBACTERIAL HAND -VANILLA BROWN SUGAR- triclosan soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 25, 2012

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  • Drug Facts


  • Active Ingredient:

    Triclosan 0.15%

  • Purpose

    Antibacterial

  • Uses:

    For handwashing to decrease bacteria on the skin

  • Warnings

    For external use only.

    When using this product, avoid contact with eyes.

    In case of eye contact, flush with water.

    Keep out of reach of children, except under adult supervision.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Add palm full of hand soap to wet hands, Scrub thoroughly rinse.

  • Inactive Ingredients

    Distilled Water, Sodium CHloride, Sodium Lauryl Ether Sulfate, N,N-dimethyldodecylamine-N-oxide sol, Lauril Sulfato de Sodio,  Sodio C14-16 Olefina Sulfonato, Triclosan, Citric Acid, Mezcla de 5-cloro-2-metil-3(2H)-isotiazolon.2-Metil-2Hisotiazol-3-on, Fragrance, FD C Yellow No.5 and Yellow No.6.

  • SPL UNCLASSIFIED SECTION

    All Rights Reserved

    Distributed By:

    LONKEY OVERSEAS INCORPORATION

    MADE IN CHINA

  • Antibacterial Hand Soap - Vanilla Brown Sugar 17oz/500ml (42302-011-00

    Antibacterial

    Hand Soap

    Vanilla

    Brown Sugar

    17.00FL OZ (500ml)

    VanillaBrownSugar

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND -VANILLA BROWN SUGAR 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42302-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.15 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    DIMETHYL LAURAMINE (UNII: 6V2OM30I1Z)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    SODIUM C14 OLEFIN SULFONATE (UNII: N816E2SOKI)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42302-011-00500 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333E01/25/2012
    Labeler - Lonkey Overseas Inc. (017448266)
    Registrant - Lonkey Industrial Co., Ltd. Guangzhou (654539139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lonkey Industrial Co., Ltd. Guangzhou654539139manufacture
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