Label: PSORIASIN DAYTIME SKIN RELIEF- coal tar cream

  • NDC Code(s): 52389-765-04
  • Packager: Alva-Amco Pharmacal Companies, Inc
  • 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 15, 2020

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

  • Active ingredient

    Coal tar 0.5% (from Coal Tar Topical Solution, USP 20%)

  • Purpose

    Psoriasis / Seborrheic Dermatitis Treatment

  • Uses

    For the relief of symptoms associated with psoriasis and/or seborrheic dermatitis including itching, scaling, flaking, redness and irritation 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
    • around the rectum or in the genital area or groin
    • with other forms of psoriasis therapy such as ultraviolet radition or prescription drugs
  • When using this product

    avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

  • Stop use and ask a doctor if

    • condition worsens
    • condition does not improve after regular use of this product as directed.
  • PRECAUTIONS

    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 center right away.

  • Directions

    • Read all package directions and warnings before use.
    • Use only as directed.
    • Apply (gently massage in) a small amount of PSORIASIN to affected areas.
    • Apply one to four times daily or as directed by a doctor.
    • Apply to thoroughly dry skin.
    • The active ingredient, coal tar, in PSORIASIN may affect very light hair color; test first on a small patch of hair before broader application to areas where light colored hair is present.
    • Wash affected areas at least daily with mild soap and warm water and dry thoroughly.
    • Intended 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 directed by a doctor.
  • Other information

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

  • Inactive ingredients

    Aloe barbadensis leaf juice, Artemisia mogolia leaf extract, Butylene glycol, Caprylic/capric triglyceride, Caprylyl glycol, Centella asiatica (Gotu kola) extract, Ceteareth-20, Cetearyl alcohol, Chlorphenesin, Citric acid, Cocos nucifera (coconut) oil, Disodium EDTA, Ethanol, Ginkgo biloba leaf extract, Glycerin, Glyceryl stearate, Glycyrrhiza glabra (licorice) root extract, Mahonia aquifolium (Oregon grape) extract, Phenoxyethanol, Polysorbate 80, Rosa canina fruit oil, Sodium citrate, Tamarindus indica fruit extract, Vaccinium corymbosum (Blueberry) fruit, Vitamin D3, Water and Zea mays (corn) oil.

  • Questions?

    1-800-792-2582

  • PRINCIPAL DISPLAY PANEL

    Psoriasin Daytime Skin Relief PDP

  • INGREDIENTS AND APPEARANCE
    PSORIASIN DAYTIME SKIN RELIEF 
    coal tar cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-765
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ARTEMISIA MONGOLICA LEAF (UNII: WY03A2288R)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    VACCINIUM CORYMBOSUM WHOLE (UNII: G1DGA0BS6T)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CORN OIL (UNII: 8470G57WFM)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TAMARIND JUICE (UNII: 5P6V8403U4)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALCOHOL (UNII: 3K9958V90M)  
    GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAHONIA AQUIFOLIUM FRUITING TOP (UNII: P119855ERN)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52389-765-041 in 1 CARTON12/26/2018
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/26/2018
    Labeler - Alva-Amco Pharmacal Companies, Inc (042074856)