Label: ECOSAVE LAVENDER ANTIBACTERIAL HAND SOAP- triclosan kit

  • 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 December 1, 2009

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Triclosan .04%

  • Purpose

    Antibacterial

  • Warnings

    For external use only

    Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if irritation or redness develops.

    Keep away from children, except under adult supervision. If swallowed, get medical help or contact a Posion Control Center right away.

  • DOSAGE & ADMINISTRATION

    Wet hands. Apply palmful to hands. Scrub thoroughly. Rinse.

  • Inactive Ingredients

    water, polyoxyethylene fatty alcohol sodium sulfate, dehyton KE, Sodium Chloride, cocoamidopropyalamine oxide, fragrance, coconut oil diethanolamide, citric acid, disodium EDTA, kathon, FD and C red 33, FD and C blue 1

  • PRINCIPAL DISPLAY PANEL

    artworkPACKAGE LABEL

  • INGREDIENTS AND APPEARANCE
    ECOSAVE LAVENDER ANTIBACTERIAL HAND SOAP 
    triclosan kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:18018-502
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:18018-502-341 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 POUCH 1000 mL
    Part 21 BOTTLE, PUMP 237 mL
    Part 1 of 2
    ECOSAVE LAVENDER ANTIBACTERIAL HAND SOAP 
    antibacterial soap liquid
    Product Information
    Item Code (Source)NDC:18018-502
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN.04 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11000 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33312/01/2009
    Part 2 of 2
    ECOSAVE LAVENDER ANTIBACTERIAL HAND SOAP 
    antibacterial soap liquid
    Product Information
    Item Code (Source)NDC:18018-502
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN.04 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1237 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33312/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33312/01/2009
    Labeler - NINGBO CLEANER DAILY USED PRODUCTS (527983808)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO CLEANER DAILY USED PRODUCTS527983808manufacture