PURGO SATIN FOAM (TRICLOSAN) SOAP [CERTUS MEDICAL, INC.]

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PURGO SATIN FOAM (TRICLOSAN) SOAP [CERTUS MEDICAL, INC.]
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NDC 75990-793-06, 75990-793-08
Set ID 67317668-57f7-4602-90ff-c5a3ba8983f1
Category HUMAN OTC DRUG LABEL
Packager Certus Medical, Inc.
Generic Name
Product Class
Product Number
Application Number
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  • Drug Facts Box OTC-Active Ingredient Section

    Triclosan 0.3%

  • Drug Facts Box OTC-Purpose Section

    Antiseptic

  • Drug Facts Box OTC-Indications & Usage Section

    for hand-washing to decrease bacteria on the skin

  • Drug Facts Box OTC-Warnings Section

    For external use only

  • Drug Facts Box OTC-When Using Section

    do not get into eyes

    if contact occurs, rinse eyes thoroughly with water

  • Drug Facts Box OTC-Stop Use Section

    irritation and redness develop

  • Drug Facts Box OTC-Keep Out of Reach of Children Section

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

  • Drug Facts Box OTC-Dosage & Administration Section


    wet hands and forearms

    apply 5 milliliters (teaspoonful) or palmful to hands and forearms

    scrub thoroughly for 1 minute and rinse

  • Drug Facts Box OTC-Inactive Ingredient Section

    water, propylene glycol, alcohol denat., disodium cocoamphodipropionate, lauric acid, ethanolamine, lactic acid, isopropyl alcohol, tetrasodium EDTA, polyquaternium 10,  PEG-4, fragrance, methylparaben, propylparaben, FDC red 4, acid red 1

  • 6793 Purgo Satin Foam Drug Facts and Label

    6793 Purgo Satin Foam Drug Facts and Label    6793 product label6793 product label

  • INGREDIENTS AND APPEARANCE
    PURGO SATIN FOAM 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75990-793
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN3.0 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75990-793-061 in 1 BOX12/15/2017
    1800 mL in 1 BAG; Type 0: Not a Combination Product
    2NDC:75990-793-081 in 1 BOX12/15/2017
    21000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/15/2017
    Labeler - Certus Medical, Inc. (966433653)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture(75990-793)
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