Label: PSORIASIN IN-SHOWER TREATMENT- coal tar lotion/shampoo

  • NDC Code(s): 52389-670-05
  • Packager: Alva-Amco Pharmacal Companies, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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

  • Active Ingredient

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

  • Purpose

    Psoriasis / Seborrheic Dermatitis Treatment

  • Uses

    For the relief of symptoms of psoriasis and/or seborrheic dermatitis including itching, scaling, flaking, redness and irriation of the skin. Helps prevent recurrence.

  • Warnings

    For external use only.

  • Ask a doctor before use

    • for prolonged periods
    • if condition covers a large area of the body
    • 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 thoroughly with water.

  • 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.

    Warning: This product contains chemicals known to the State of California to cause cancer.

  • Keep out of reach of children.

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

  • Directions

    After cleansing, apply Psoriasin In-Shower Treatment to affected areas on body and scalp. Avoid applying to bottom of feet. Leave on for at least 2 minutes, then rinse off and gently towel dry. For best results, use at least twice a week or as directed by a doctor. The active ingredient, coal tar, in Psoriasin may affect very light hair color; test first on a few strands of hair before broader application to areas where light-colored hair is present. For use by normally healthy adults only; persons under 18 years of age or those with highly sensitive or allergic skin should use only as idrected by a doctor.

  • Other Information

    You may report serious side effects to the phone number provided under Questions? below.

  • Inactive ingredients

    Aloe vera gel, capylic/capric triglycerides, cetearyl alcohol, citric acid anhydrous, Dead Sea salts, ethanol, glycerin, glyceryl stearate SE, lavender oil, myristyl alcohol, oatmeal extract, olive oil, PEG-100 stearate, petrolatum, phenoxyethanol, polysorbate 80, shea oil, stearyl alcohol, sweet almond oil, water.

  • Questions?

    1-800-792-2582

  • PRINCIPAL DISPLAY PANEL

    PsoriasinShowerPDP

  • INGREDIENTS AND APPEARANCE
    PSORIASIN IN-SHOWER  TREATMENT
    coal tar lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-670
    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
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CETEARYL BEHENATE (UNII: 7ARI9LTH0U)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517)  
    CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    OATMEAL (UNII: 8PI54V663Y)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SHEANUT OIL (UNII: O88E196QRF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52389-670-05140 g in 1 TUBE; Type 0: Not a Combination Product03/03/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03203/03/2021
    Labeler - Alva-Amco Pharmacal Companies, LLC (042074856)