Label: ROYAL ANTIBACTERIAL PASSION PLUM 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 September 17, 2013

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  • ACTIVE INGREDIENT

    Active Ingredient                                   Purpose

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

  • PURPOSE

    Uses

    for handwashing to decrease bacteria on the skin.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

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

  • WARNINGS

    Warnings

    For external use only.

    Avoid getting into eyes. If this happens, rinse thoroughly with water.

  • 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
    ROYAL ANTIBACTERIAL PASSION PLUM HAND CLEANSE 
    triclosan gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50438-107
    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:50438-107-01500 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/17/2013
    Labeler - Filo America (943873703)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi Daily Chemical Products Co., Ltd.529047265manufacture(50438-107)
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