Label: MG217 PSORIASIS THERAPEUTIC SCALP TREATMENT- coal tar shampoo

  • NDC Code(s): 68093-5206-1
  • Packager: Wisconsin Pharmacal Company
  • 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 December 10, 2018

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  • Drug Facts

    Active Ingredient

    Coal Tar 3%

    (from Coal Tar Topical Solution, USP 20%)

  • Purpose

    Psoriasis, Seborrheic Dermatitis, Dandruff Treatment

  • INDICATIONS & USAGE

    Uses For the temporary relief of these symptoms associated with psoriasis, seborrheic dermatitis or dandruff

    • itching
    • scaling
    • flaking
    • redness
    • irritation ofthe scalp.

    Helps prevent recurrence.

  • WARNINGS

    Warnings

    For external use only.

    Ask doctor before use

    if condition covers a large area of the body.

    When using this product

    • avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
    • use caution in exposing skin to sunlight. It may increase your tendency to sunburn for up to 24 hours after application.
    • do not use with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed by a physician.
    • do not use for prolonged periods without consulting a physician.

    Stop use and ask a doctor if

    • condition worsens.
    • condition does not improve after regular use of this product as directed.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

    WARNING This product can gose you to chemicals including Coal Tar, which is known to the State of California to cause cancer.
    For more information go to www.P65Warnings.ca.gov

  • Directions

    • shake well before using.
    • wet hair then massage liberal amount of MG217 into the scalp and leave on for several minutes. Rinse thoroughly.
    • for best results, use at least twice a week or as directed by a physician.
  • Inactive ingredients

    Deionized water, Sodium Alkyl Ether Sulfate, Cocamidopropyl Betaine, Lauramidopropyl Hydroxysultaine, Palmitic Betaine, Guar Hydroxypropyltrimonium Chloride, Hydrolyzed Collagen, Phenoxyethanol, Methyl Paraben, n-Butyl Paraben, Ethyl Paraben, Isobutyl Paraben, Propyl Paraben, Fragrance FD and C No. 1

  • Questions?

    1-800-635-3696

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    MG217 PSORIASIS  THERAPEUTIC SCALP TREATMENT
    coal tar shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68093-5206
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURAMIDOPROPYL HYDROXYSULTAINE (UNII: VPE363894V)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETYL BETAINE (UNII: E945X08YA9)  
    GUAR GUM (UNII: E89I1637KE)  
    PORK COLLAGEN (UNII: I8442U2G7J)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68093-5206-11 in 1 CARTON07/01/2014
    1120 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H07/01/2014
    Labeler - Wisconsin Pharmacal Company (800873986)
    Registrant - Wisconsin Pharmacal Company (800873986)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wisconsin Pharmacal Company800873986manufacture(68093-5206)
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