PACIFIC ANTI-BACTERIAL HAND CLEANSE KIWI ESSENCE (TRICLOSAN) GEL [FILO AMERICA]

PACIFIC ANTI-BACTERIAL HAND CLEANSE KIWI ESSENCE (TRICLOSAN) GEL [FILO AMERICA]
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NDC 50438-101-01
Set ID d1ab46dd-0d09-4197-9ea1-d908dc6b08cb
Category HUMAN OTC DRUG LABEL
Packager Filo America
Generic Name
Product Class
Product Number
Application Number PART333E
  • ACTIVE INGREDIENT

    Active Ingredient                                   Purpose

    Triclosan 0.15%..................................Antibacterial

  • PURPOSE

    Uses

    for handwashing to eliminate bacteria and germs on the skin.

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Wet hand, apply palmful to hands, scrub thoroughly, Rinse.

  • WARNINGS

    Warnings

    For external use only.

    When using this productl, avoid contact with eyes, if contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor, if irritation or redness develops

  • DOSAGE & ADMINISTRATION

    Wet hand, apply palmful to hands, scrub thoroughly, Rinse.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    camphor, carbomer, ethyl alcohol, fd&c blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water, cocamide MEA, PEG-18 glycaryl

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    PACIFIC ANTI-BACTERIAL HAND CLEANSE KIWI ESSENCE 
    triclosan gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50438-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN1.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50438-101-01500 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/08/2013
    Labeler - Filo America (943873703)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi Daily Chemical Products Co., Ltd.529047265manufacture(50438-101)

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