ROYAL ANTIBACTERIAL (APPLE AND PEAR) MOISTURIZING HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]

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ROYAL ANTIBACTERIAL (APPLE AND PEAR) MOISTURIZING HAND CLEANSE (TRICLOSAN) GEL [FILO AMERICA]
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NDC 50438-602-01
Set ID b6373be0-f3aa-4306-8b6b-5e076cc72376
Category HUMAN OTC DRUG LABEL
Packager Filo America
Generic Name
Product Class
Product Number
Application Number PART333E
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  • 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.

  • Stop use and ask a doctor

    If irritation and redness develops.

  • Keep out of reach of children.

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

  • Directions

    • pump into hands
    • lather vigorously for at least 15 seconds
    • rinse and dry thoroughly.
  • Inactive Ingredients

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Sodium Chloride, Fragrance, Citric Acid, Peg-150 Distearate, Tetrasodium Edta, FD&C Yellow No.5, FD&C Blue No.1

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    ROYAL ANTIBACTERIAL (APPLE AND PEAR) MOISTURIZING HAND CLEANSE 
    triclosan gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50438-602
    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 LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50438-602-01444 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/05/2015
    Labeler - Filo America (943873703)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan Daily Chemical Products Co., Ltd.530766098manufacture(50438-602)
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