Label: MG217 PSORIASIS MULTI SYMPTOM- coal tar gel

  • 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 November 6, 2015

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

    Active Ingredient

    Coal Tar 2%

  • Purpose

    Psoriasis, Seborrheic Dermatitis, Dandruff Treatment (from Coal Tar Topical Solution, USP 20%)

  • Uses

    For the temporary relief of these symptoms associated with psoriasis and/or seborrheic dermatitis including,

    • itching
    • scaling
    • flaking
    • redness
    • irritation of the scalp

    Helps prevent recurrence.

  • Warnings

    For external use only. Use only as directed.

    Ask 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.
    • If condition worsens or does not improve after regular use of this product as directed, consult a physician.
    • Use caution in exposing skin to sunlight. It may increase your tendency to sunburn for up to 24 hours after application

    Stop use and ask a doctor if

    • condition worsens or 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. This product contains coal tar, a product known in the state of California to cause cancer.

    Flamable. Keep away from heat and open flames. Store at room temperature.

  • Inactive ingredients

    Purified Water, Alcohol, PEG-8, Polysorbate 80, PEG/PPG 18/18 Dimethicone, Propanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Fragrance, Aloe Barbadensis Leaf Juice, Dexpanthenol, Sodium Hydroxide, Caprylhdroxamic Acid, Alpha-Bisabolol, Calcium Disodium EDTA

  • Directions

    Adults aply to affected area 1 to 4 times daily or as directed by a physician.

  • Questions?

    1-800-635-3696

  • PRINCIPAL DISPLAY PANEL

    5301.jpg.jpgCarton and Label

  • INGREDIENTS AND APPEARANCE
    MG217 PSORIASIS  MULTI SYMPTOM
    coal tar gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68093-7226
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68093-7226-11 in 1 CARTON08/01/2014
    142.5 g in 1 TUBE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H08/01/2014
    Labeler - Wisconsin Pharmacal Company (800873986)
    Registrant - Wisconsin Pharmacal Company (800873986)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wisconsin Pharmacal Company800873986manufacture(68093-7226)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!