HAND (TRICLOSAN) SOAP [PERSONAL CARE PRODUCTS]

HAND (TRICLOSAN) SOAP [PERSONAL CARE PRODUCTS]
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NDC 29500-907-77
Set ID 9cc03257-1bee-495b-8676-da83928581cf
Category HUMAN OTC DRUG LABEL
Packager Personal Care Products
Generic Name
Product Class
Product Number
Application Number PART333A
  • ACTIVE INGREDIENT



    Active ingredient

    .2% triclosan

  • PURPOSE



    Purpose  antibacterial

  • 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



    Uses for hand washing to decrease bacteria on the skin

  • WARNINGS



    Warnings

    for external use only

    When using this product avoid contact with eyes. In case of eye contact, flush with water.

    Stop use and ask a doctor if irritation and redness develops

  • DOSAGE & ADMINISTRATION

    Directions

    Pump into hands

    lather vigorously for at least 15 seconds

    rinse and dry thoroughly

  • INACTIVE INGREDIENT



    Inactive ingredients

    water (aqua), sodium laureth sulfate, sodium chloride, cocamide DEA, DMDM hydatoin, fragrance, citric acid, tetrasodium EDTA, red#33, red#4

  • PRINCIPAL DISPLAY PANEL

    label


    Personal care

    antibacterial kills 99% of germs

    Hand soap

    refill

    raspberry

    15 fl oz (444ml)

  • INGREDIENTS AND APPEARANCE
    HAND 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-907
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN.888 mL  in 444 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-907-77444 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/2011
    Labeler - Personal Care Products (966155082)
    Registrant - Personal Care Products (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Unichem Household Products Co.Ltd528196956manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi529047265manufacture

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