Label: MG217 PSORIASIS MEDICATED MULTI-SYMPTOM- coal tar ointment

  • NDC Code(s): 68093-7233-1
  • 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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  • ACTIVE INGREDIENT

    Active ingredient

    Coal Tar 2% (from Coal Tar Topical Solution, USP 20%)

  • PURPOSE

    Purpose

    Psoriasis, Seborrheic Dermatitis, Dandruff Treatment

  • INDICATIONS & USAGE

    Uses For the relief of these symptoms associated with psoriasis and/or seborrheic dermatitis ■ itching ■ scaling
    ■ flaking ■ redness ■ irritation of the skin. Helps prevent recurrence.

  • WARNINGS

    Warnings
    For external use only. Use only as directed.

    Ask a doctor before use ■ for prolonged periods ■ if condition covers a large area of the body ■ around the rectum or in the genital area or groin ■ with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs ■ do not use for prolonged periods without consulting a physician.

    When using this product ■ Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water. ■ Not recommended for use on scalp unless directed by a physician, ointment may be difficult to remove from hair.

    Stop use and ask a doctor if ■ condition worsens ■ condition does not improve after regular use of this product as directed. Use caution in exposing skin to sunlight after applying this product, as it may increase your tendency to sunburn for up to 24 hours after application.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

    WARNING: This product can expose 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

  • DOSAGE & ADMINISTRATION

    Directions
    Apply to affected areas 1 to 4 times daily or as directed by a physician.

  • INACTIVE INGREDIENT

    Inactive ingredients
    Petrolatum, C12-15 Alkyl Benzoate, Bis-Diglyceryl Polyacyladipate-2, PEG/PPG-18/18 Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Vitamin E Acetate, Vitamin A (retinyl palmitate), Vitamin D 3 (cholecalciferol)

  • QUESTIONS

    Questions or comments? 1-800-635-3696

  • PRINCIPAL DISPLAY PANEL

    Labelcarton

  • INGREDIENTS AND APPEARANCE
    MG217 PSORIASIS  MEDICATED MULTI-SYMPTOM
    coal tar ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68093-7233
    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
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68093-7233-11 in 1 CARTON02/01/2018
    1107 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H02/01/2018
    Labeler - Wisconsin Pharmacal Company (800873986)
    Registrant - Wisconsin Pharmacal Company (800873986)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wisconsin Pharmacal Company800873986manufacture(68093-7233)
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