Label: PURGO SATIN FOAM- triclosan soap

  • 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 December 18, 2017

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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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