TARSUM PROFESSIONAL- coal tar shampoo

TARSUM PROFESSIONAL by

Drug Labeling and Warnings

TARSUM PROFESSIONAL by is a Otc medication manufactured, distributed, or labeled by Summers Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

TARSUM PROFESSIONAL 
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11086-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11086-011-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/30/2013
2	NDC: 11086-011-02	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/30/2013

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)