Label: ANTIBACTERIAL HAND- triclosan liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 1, 2012

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  • SPL UNCLASSIFIED SECTION

    ShopRite Antibacterial Liquid Hand Soap is made with an antibacterial formula that eliminates the dirt yo see and the germs you don't.  ShopRite Antibacterial Liquid Hand Soap actually helps kill
    germs and bacteria on contact so its perfect for use at both bathroom and kitchen sink.  ShopRite Antibacterial Liquid Hand Soap is effective, yet gentle and mild, so it's great for the entire family.
  • ACTIVE INGREDIENT

    Active Ingredient
    Triclosan 0.15%

    Purpose
    Antibacterial
  • INDICATIONS & USAGE

    Uses for handwashing to decrease bacteria on the skin
  • WARNINGS

    Warnings
    For external use only.

    When using this product •do not get into eyes.  If contact occurs rinse eyes thoroughly with water.

    Stop use and ask a doctor if •irritation or redness develops.

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

    Directions • wet hands •apply palmful to hands •scrub thoroughly •rinse
  • INACTIVE INGREDIENT

    Inactive ingredients  water, sodium laureth sulfate, sodium, lauryl sulfate, cocamidopropyl betaine, sodium chloride, decyl glucoside, glycerin,
    PEG-18 glyceryl oleate/cocoate, fragrance, cocamide MEA, DMDM hydantoin, tetrasodium EDTA, citric acid, yellow 5, red 4
  • ADVERSE REACTIONS

    Quality Guarantee
    We welcome your questions and comments.
    Call: 1-800-ShopRite (8am-8pm EST)
    E-mail: www.shoprite.com
    Write: Wakefern Food Corp. Consumer Affairs P7-103
    600 York St Elizabeth, NJ07207
    Please provide product UPC and code stamped on product
    Distributed by Wakefern Food Corporation
    5000 Riverside Drive
    Keasbey, NJ 08832
  • PRINCIPAL DISPLAY PANEL

    ShopRite
    Antibacterial
    Liquid
    Hand
    Soap
    Refill
    64 FL OZ (2QT) 1.89 L
    image of principal display panel
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41190-243
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.15 kg  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-18 GLYCERYL OLEATE/COCOATE (UNII: VD2D270332)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41190-243-96.221 L in 1 BOTTLE, PLASTIC
    2NDC:41190-243-571.18 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333A01/06/2009
    Labeler - Wakefern Food Corporation (069722418)
    Registrant - Vi-Jon (088520668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture
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