Label: TARSUM PROFESSIONAL- coal tar shampoo

  • NDC Code(s): 11086-011-01, 11086-011-02
  • Packager: Summers Laboratories Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 9, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    CONTAINS

    2% COAL TAR

    (10% LCD EQUIV. TO 2% COAL TAR)

  • PURPOSE

    PURPOSE

    PSORIASIS, SEBORRHEIC DERMATITIS, DANDRUFF TREATMENT

  • INDICATIONS & USAGE

    USE

    • CONTROLS ITCHING, FLAKING AND REDNESS DUE TO PSORIASIS, SEBORRHEIC DERMATITIS AND DANDRUFF
  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

  • ASK DOCTOR

    Ask a doctor before use if you have

    • condition that covers a large area of the body
    • condition in or around the rectum or genitals
  • WHEN USING

    When using this product

    • avoid contact with 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 up to 24 hours after application.
    • do not use for prolonged periods without consulting a doctor.
    • do not use this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor.
  • STOP USE

    Stop and ask a doctor if

    • condition worsens or does not improve after regular use as directed
    • excessive irritation occurs
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTCT A POISON CONTROL CENTER RIGHT AWAY.

  • OTHER SAFETY INFORMATION

    Other information

    In rare instances, temporary discoloration of gray or blonde hair may occur.

  • DOSAGE & ADMINISTRATION

    Directions

    • For use as a scalp treatment before showering: Twist open applicator tip. Apply evenly to affected areas. Leave on for 5 minutes, gradually increasing treatment time to 1 hour, or as directed by your doctor. Rinse thoroughly.
    • As a shampoo: Wet hair, apply Tarsum for several minutes, then rinse.
    • For best results use twice a week or as directed by a physician.

  • INACTIVE INGREDIENT

    Inactive ingredients

    water, TEA lauryl sulfate, cocamide DEA, sodium lauryl sulfate, ethanol (8%), salicylic acid, triethanolamine, glycerin, lauryl alcohol, diethanolamine, sodium chloride, polysorbate 80, fragrance

  • OTHER SAFETY INFORMATION

    Store at controlled room temperature

    59° to 86° F (15° to 30° C)

  • QUESTIONS

    Questions or comments?

    Call 1-800-533-7546 (USA and Canada)

    For more information go to www.sumlab.com

  • PRINCIPAL DISPLAY PANEL

    Tarsum 4oz_Unit Carton

    Tarsum 8 oz_Label

  • INGREDIENTS AND APPEARANCE
    TARSUM PROFESSIONAL 
    coal tar shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11086-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ALCOHOL (UNII: 3K9958V90M) 8 g  in 100 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURYL ALCOHOL (UNII: 178A96NLP2)  
    DIETHANOLAMINE (UNII: AZE05TDV2V)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11086-011-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/30/2013
    2NDC:11086-011-02236 mL in 1 BOTTLE; Type 0: Not a Combination Product10/30/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03210/30/2013
    Labeler - Summers Laboratories Inc (002382612)