Label: PEAR BLOSSOM ANTIBACTERIAL GEL HAND WASH- triclosan liquid

  • 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 February 3, 2016

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  • Drug Facts

    Active Ingredient

    Triclosan 0.115%

  • Purpose

    Antibacterial

  • WARNINGS

    For external use only - hands only

  • WHEN USING

    When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

  • STOP USE

    Stop use and ask a doctor if

    • Irritation or redness develops
    • condition persists for more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • wet hands
    • apply palmful to hands
    • scrub throughly
    • rinse throughly
  • Inactive Ingredients

    Water, Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Betaine, Fragrance (Parfum), Sodium Lauroamphoacetate, Polyquaternium 7, Glycerin, Citric Acid, Aloe Barbadensis Leaf Extract, Pyrus Communis (Pear) Fruit Extract, Tocopheryl (Vitamin E) Acetate, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5 (Cl 19140), Blue 1 (Cl 42090)

  • Uses

    for handwashing or decrease bacteria to the skin

  • PRINCIPAL DISPLAY PANEL

    Pear Blossom Gel Hand WashPEAR BLOSSOM

    ANTIBACTERIAL

    Gel Hand Wash

    Kills 99.99% of Germs

    14 FL OZ (414 mL)

  • INGREDIENTS AND APPEARANCE
    PEAR BLOSSOM ANTIBACTERIAL GEL HAND WASH 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN1.15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 2600000 MW) (UNII: U1G23TFV1K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PEAR (UNII: 2ZN8DWC0YF)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-118-14414 mL in 1 BOTTLE; Type 0: Not a Combination Product02/03/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/03/2016
    Labeler - Brands International (243748238)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brands International243748238manufacture(50157-118)
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