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Therapeutic by Western Family Foods

Dosage form: shampoo
Ingredients: COAL TAR 2.5mL in 100L
Labeler: Western Family Foods
NDC Code: 55312-205

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.

Drug Facts

Active ingrident
2.5% Coal Tar Topical Solution
(0.5% Coal Tar)

Purpose
Anti-Dandruff

Use controls the symptoms of:
•dandruff •seborrheic dermatitis •psoriasis

Warnings
For external use only

Ask a doctor before use if you have a condition which covers a large part of the body

When using this product
•do not get into 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 for up to 24 hours after application
•do not use for prolonged periods without consulting a doctor
•do not use with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor.

Stop use and ask a doctor if condition worsens or does not improve
after regular use of this product as directed.

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions
•wet hair thoroughly
•massage shampoo into scalp
•lather.  Leave on hair and scalp for several minutes
•rinse and repeat
•for best results use at least twice a week or as directed by a doctor

Other information
•store away from direct sunlight
•in rare instances, discoloration of gray, blonde, bleached, or tinted hair may occur

Inactive ingredients water, sodium laureth sulfate, cocamide DEA, laureth-4,
ccocamidopropyl betaine, fragrance, sodium chloride, citric acid, imidazolidinyl urea,
tetrasodium EDTA, methylparaben, propylparaben, caramel, FD+C red #4

Proudly Distributed by
Western Family Foods, Inc.
P.O. Box 4057
Portland, OR 97208
www.westernfamily.com

This product is not manufactured or distributed by the Neutrogena
Corporation, distributor of Neutrogena Therapeutic T/Gel Shampoo

WESTERN FAMILY
Therapeutic Coal Tar
Anti-Dandruff Shampoo
original formula
Long-Lasting
relief of itching
and flaking
controls the symptoms of:
dandruff, psoriasis, and seborrheic dermatitis
WITH 2.5% COAL TAR TOPICAL SOLUTION USP
COMPARE TO NEUTROGENA
THERAPEUTIC T-GEL SHAMPOO
4.4 FL OZ (130 mL)
THERAPEUTIC 
coal tar shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-205
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COAL TAR (COAL TAR) COAL TAR2.5 mL  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURETH SULFATE 
COCO DIETHANOLAMIDE 
LAURETH-4 
COCAMIDOPROPYL BETAINE 
SODIUM CHLORIDE 
CITRIC ACID MONOHYDRATE 
IMIDUREA 
EDETATE SODIUM 
METHYLPARABEN 
PROPYLPARABEN 
CARAMEL 
FD&C RED NO. 4 
Packaging
#Item CodePackage Description
1NDC:55312-205-23.251 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H12/01/2011
Labeler - Western Family Foods (192166072)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture

Revised: 06/2012
 
Western Family Foods

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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