Label: ROYAL ANTIBACTERIAL RASPBERRY HAND CLEANSE- triclosan gel 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/13

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  • ACTIVE INGREDIENT

    Active Ingredient                                   Purpose

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

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  • PURPOSE

    Uses

    for handwashing to decrease bacteria on the skin.

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  • 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.

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  • INDICATIONS & USAGE

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

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  • WARNINGS

    Warnings

    For external use only.

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

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  • DOSAGE & ADMINISTRATION

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

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  • 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

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  • INGREDIENTS AND APPEARANCE
    ROYAL ANTIBACTERIAL RASPBERRY HAND CLEANSE 
    triclosan gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50438-106
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRICLOSAN (TRICLOSAN) TRICLOSAN 1.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM C14-16 OLEFIN SULFONATE  
    SODIUM LAURETH SULFATE  
    COCO DIETHANOLAMIDE  
    SODIUM CHLORIDE  
    PEG-150 DISTEARATE  
    CITRIC ACID MONOHYDRATE  
    GLYCERIN  
    EDETATE DISODIUM  
    .ALPHA.-TOCOPHEROL ACETATE  
    METHYLCHLOROISOTHIAZOLINONE  
    FD&C YELLOW NO. 5  
    METHYLISOTHIAZOLINONE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50438-106-01 500 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 09/17/2013
    Labeler - Filo America (943873703)
    Establishment
    Name Address ID/FEI Business Operations
    Ningbo Pulisi Daily Chemical Products Co., Ltd. 529047265 manufacture(50438-106)
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