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
  • 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 March 3, 2021

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)  
    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)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    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 finalpart358H03/03/2021
    Labeler - Alva-Amco Pharmacal Companies, LLC (042074856)