Label: PSORIATAR (COAL TAR)- coal tar aerosol, foam

  • 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 May 5, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Coal Tar 2% (from Coal Tar Topical Solution USP, 10%)

  • Purpose

    Psoriasis

  • Use

    for the relief of symptons of psoriasis

  • Warnings

    For external use only

    Flammable

    Avoid fire, flame, or smoking during and immediately following application.

    Do not use

    • for prolonged periods without consulting a doctor
    • this product in or around the rectum or in the genital area or groin except on the advice of a doctor

    Ask a doctor before use if you have a condition that covers large areas of the body.

    Ask a doctor or pharmacist before use if you are using the product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs.

    When using this product

    • avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
    • use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application.
    • Product can stain clothing, contact lenses and hair. To minimize staining, allow product to dry before contact.

    Stop use and ask doctor if condition worsens or does not improve after regular use of this product as directed.

    If pregnant or breast feeding, ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a poison control center right away.

  • Directions

    • Shake the can before use.
    • Invert the can to dispense. Upright dispensing will cause loss of propellant.
    • Apply to affected areas one to four times daily or as directed by a doctor.
  • Other Information

    • Contents under pressure. Do not puncture or incinerate.
    • Store at 68°-77°F (20°-25°C).
    • Do not expose to heat or at temperatures above 120°F (49°C).
  • Inactive Ingredients

    Alcohol denatured, caprylic/capric triglyceride, ceteareth-20, cyclopentasiloxane, dimethicone, disodium edta, glycerin, hydroxypropyl methylcellulose, isobutane, isopropyl myristate, mentha piperita (peppermint) oil, phenoxyethanol, polysorbate 80, potassium sorbate, propane, sodium chloride, sodium citrate, stearic acid, water (aqua), xantham gum

  • Questions?

    1-877-977-0687

  • PRINCIPAL DISPLAY PANEL - 100 g Can Label

    75834-101-01
    PSORIASIS FOAM

    Psoriatar™

    (Coal Tar) Foam 2%

    NIVAGEN
    PHARMACEUTICALS

    Net wt. 3.5 oz (100 g)

    PRINCIPAL DISPLAY PANEL - 100 g Can Label
  • INGREDIENTS AND APPEARANCE
    PSORIATAR (COAL TAR) 
    coal tar aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75834-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Coal Tar (UNII: R533ESO2EC) (Coal Tar - UNII:R533ESO2EC) Coal Tar20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Isopropyl Alcohol (UNII: ND2M416302)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Glycerin (UNII: PDC6A3C0OX)  
    Hypromelloses (UNII: 3NXW29V3WO)  
    Isobutane (UNII: BXR49TP611)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Propane (UNII: T75W9911L6)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Water (UNII: 059QF0KO0R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75834-101-011 in 1 CARTON05/15/2016
    1100 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H05/15/2016
    Labeler - Nivagen Pharmaceuticals, Inc. (052032418)
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