Your browser does not support JavaScript! TARSUM PROFESSIONAL (COAL TAR) SHAMPOO [SUMMERS LABORATORIES INC]
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TARSUM PROFESSIONAL (coal tar) shampoo
[Summers Laboratories Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

CONTAINS

2% COAL TAR

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

PURPOSE

PSORIASIS, SEBORRHEIC DERMATITIS, DANDRUFF TREATMENT

USE

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

WARNINGS

FOR EXTERNAL USE ONLY

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 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 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. IF SWALLOWED, GET MEDICAL HELP OR CONTCT A POISON CONTROL CENTER RIGHT AWAY.

Other information

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

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 ingredients

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

Store at controlled room temperature

59° to 86° F (15° to 30° C)

Questions or comments?

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

For more information go to www.sumlab.com

Tarsum 4oz_Unit Carton

Tarsum 8 oz_Label

TARSUM PROFESSIONAL 
coal tar shampoo
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11086-011
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COAL TAR (COAL TAR) COAL TAR2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
TRIETHANOLAMINE LAURYL SULFATE 
COCO DIETHANOLAMIDE 
SODIUM LAURYL SULFATE 
ALCOHOL8 g  in 100 mL
SALICYLIC ACID 
TROLAMINE 
GLYCERIN 
LAURYL ALCOHOL 
DIETHANOLAMINE 
SODIUM CHLORIDE 
POLYSORBATE 80 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11086-011-111 in 1 BOX
1NDC:11086-011-01118 mL in 1 BOTTLE
2NDC:11086-011-02236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H10/30/2013
Labeler - Summers Laboratories Inc (002382612)
Establishment
NameAddressID/FEIBusiness Operations
Summers Laboratories Inc002382612manufacture(11086-011), pack(11086-011)

Revised: 11/2013
 
Summers Laboratories Inc

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