Label: ROYAL ANTIBACTERIAL (APPLE AND PEAR) MOISTURIZING HAND CLEANSE- triclosan gel

  • 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 5, 2015

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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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