Label: TARSUM PROFESSIONAL- coal tar shampoo

  • NDC Code(s): 11086-011-01, 11086-011-02, 11086-011-11
  • Packager: Summers Laboratories Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/14

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

  • ACTIVE INGREDIENT

    CONTAINS

    2% COAL TAR

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

    Close
  • PURPOSE

    PURPOSE

    PSORIASIS, SEBORRHEIC DERMATITIS, DANDRUFF TREATMENT

    Close
  • INDICATIONS & USAGE

    USE

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

    WARNINGS

    FOR EXTERNAL USE ONLY

    Close
  • 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
    Close
  • 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.
    Close
  • STOP USE

    Stop and ask a doctor if

    • condition worsens or does not improve after regular use as directed
    • excessive irritation occurs
    Close
  • 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.

    Close
  • OTHER SAFETY INFORMATION

    Other information

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

    Close
  • 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.

    Close
  • 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

    Close
  • OTHER SAFETY INFORMATION

    Store at controlled room temperature

    59° to 86° F (15° to 30° C)

    Close
  • QUESTIONS

    Questions or comments?

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

    For more information go to www.sumlab.com

    Close
  • INGREDIENTS AND APPEARANCE
    TARSUM PROFESSIONAL 
    coal tar shampoo
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11086-011
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    COAL TAR (COAL TAR) COAL TAR 2 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    TRIETHANOLAMINE LAURYL SULFATE  
    COCO DIETHANOLAMIDE  
    SODIUM LAURYL SULFATE  
    ALCOHOL 8 g  in 100 mL
    SALICYLIC ACID  
    TROLAMINE  
    GLYCERIN  
    LAURYL ALCOHOL  
    DIETHANOLAMINE  
    SODIUM CHLORIDE  
    POLYSORBATE 80  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11086-011-11 1 in 1 BOX
    1 NDC:11086-011-01 118 mL in 1 BOTTLE
    2 NDC:11086-011-02 236 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 10/30/2013
    Labeler - Summers Laboratories Inc (002382612)
    Establishment
    Name Address ID/FEI Business Operations
    Summers Laboratories Inc 002382612 manufacture(11086-011), pack(11086-011)
    Close