Label: LEMON ZEST ANTIBACTERIAL HAND- 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 June 24, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient                                             Purpose

    Triclosan   0.115%                                             Antibacteria

  • INDICATIONS & USAGE

    Uses:  For hand washing to decrease bacteria on skin

  • WARNINGS

    Warnings:

    For external use only

    When using this product, avoid contact with eyes. In case of 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 right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Wet hands
    • Apply small amount to hands
    • Scrub thoroughly
    • Rinse
    • For children under 6, use only under adult supervision.


  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Water (aqua), Sodium Laureth Sulfate,  Sodium Lauryl Sulfate, Cocamidopropyl Betaine,  Sodium Chloride, Decyl Glucoside,  Cocamide DEA,  Fragrance (Parfum), DMDM Hydantoin, Citric Acid, Disodium EDTA, FD and C Yellow No. 5

  • PRINCIPAL DISPLAY PANEL

    pictulabel

  • INGREDIENTS AND APPEARANCE
    LEMON ZEST ANTIBACTERIAL HAND 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34460-6003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.115 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 84.034 g  in 100 g
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 2.1 g  in 100 g
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) 2.5 g  in 100 g
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 2.5 g  in 100 g
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 2.0 g  in 100 g
    COCAMIDE DIETHANOLAMINE (UNII: 92005F972D) 1.5 g  in 100 g
    DMDM HYDANTOIN (UNII: BYR0546TOW) 1.3 g  in 100 g
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 1.1 g  in 100 g
    EDETATE DISODIUM (UNII: 7FLD91C86K) 1.25 g  in 100 g
    LEMON (UNII: 24RS0A988O) 0.3 g  in 100 g
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.001 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34460-6003-1225 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33307/07/2010
    Labeler - Zhejiang Blue Dream Cosmetics Co., Ltd. (529047234)
    Registrant - Zhejiang Blue Dream Cosmetics Co., Ltd. (529047234)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Blue Dream Cosmetics Co., Ltd.529047234manufacture
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