Label: PACIFIC- antibaceterial hand soap rose soap

  • 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 March 4, 2010

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  • ACTIVE INGREDIENT

    Triclosan 0.15%......................................................................Antibacterial
  • PURPOSE

    Uses For handwashing to eliminate bacteria and germs on the skin.
  • WARNINGS

    For external use only.
  • WHEN USING

    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.
  • KEEP OUT OF REACH OF CHILDREN

    Keep away from children, except under adult supervision.  If swallowed, get medical help or contact a Poison Control Center right away.
  • INDICATIONS & USAGE

    Directions * Wet Hands * Apply palmful to hands * Scrub thoroughly * Rinse
  • INACTIVE INGREDIENT

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Decyl Glucoside, Glycerin, DMDM Hydantoin, PEG-18 Glyceryl Oleate/Cocoate, Fragrance, Cocamide MEA, Tetrasodium EDTA, Citric Acid, FD and C Red No. 33.
  • PRINCIPAL DISPLAY PANEL

    MM1

    Label for 64 oz


    MM2

    Label for 8 oz
  • INGREDIENTS AND APPEARANCE
    PACIFIC  
    antibaceterial hand soap rose soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29860-213
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN318.975 mL  in 2126.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sodium Laureth Sulfate (UNII: BPV390UAP0)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Glycerin (UNII: PDC6A3C0OX)  
    GLYCERYL MONOOLEATE (UNII: 4PC054V79P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    Colorpink (pink) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29860-213-131089 mL in 1 BOTTLE, PLASTIC
    2NDC:29860-213-15236.5 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33303/04/2010
    Labeler - Ningbo United (544900137)
    Registrant - Ningbo United (544900137)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo United 544900137manufacture
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