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 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
Document Id: ac9e0a79-f76d-4ec3-95c0-5f635e85647b
Set id: d990a3d8-8be8-44e3-8e84-a6d8da21f3b5
Version: 1
Effective Time: 20131107
 
Summers Laboratories Inc