Label: PIER 1 IMPORTS SWEET ORANGE ANTI-BACTERIAL HAND WASH N/A- anti-bacterial hand wash 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 December 3, 2009

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  • ACTIVE INGREDIENT

    Active ingredients                                               Purpose

    Triclosan 0.115%                                               Antibacterial

  • DESCRIPTION

    Uses    For hand washing to decrease bacteria on skin

  • WARNINGS

    Warnings

    For external use only

    When using this productavoid 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

  • WHEN USING

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


  • INACTIVE INGREDIENT

    Inactive ingredients

    Water (Aqua), Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Cocamide DEA, Fragrance (Parfum), DMDM Hydantoin, Citric acid, Disodium EDTA, FD and C Red No. 33, FD and C Yellow No. 5

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    PIER 1 IMPORTS SWEET ORANGE ANTI-BACTERIAL HAND WASH  N/A
    anti-bacterial hand wash liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49981-013
    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) 81.19552 g  in 100 g
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 10 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) 1.85 g  in 100 g
    1,3-DIMETHYLOL-5,5-DIMETHYL-HYDANTOIN (UNII: BYR0546TOW) 0.5 g  in 100 g
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.009 g  in 100 g
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.03 g  in 100 g
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.00019 g  in 100 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorORANGE (Sweet Orange) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49981-013-01300 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33312/30/2009
    Labeler - Xiamen Anna Global Co., Ltd (527060704)
    Registrant - Xiamen Anna Global Co., Ltd (527060704)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Anna Global Co., Ltd527060704manufacture