TARSUM PROFESSIONAL- coal tar shampoo 
Summers Laboratories Inc

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.

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CONTAINS

2% COAL TAR

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

PURPOSE

PSORIASIS, SEBORRHEIC DERMATITIS, DANDRUFF TREATMENT

USE

WARNINGS

FOR EXTERNAL USE ONLY

Ask a doctor before use if you have

When using this product

Stop and ask a doctor if

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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:11086-011
Route of Administration TOPICAL DEA Schedule     
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:11086-011-11 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)

Revised: 10/2014
Document Id: 061dad65-c4c5-0be7-e054-00144ff88e88
Set id: d990a3d8-8be8-44e3-8e84-a6d8da21f3b5
Version: 3
Effective Time: 20141023
 
Summers Laboratories Inc