THERAPEUTIC- coal tar shampoo
Western Family Foods

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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Coal Tar Shampoo
205

Active ingredient

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

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

Proudly Distributed by

Western Family Foods, Inc.

P.O. Box 4057

Portland, OR 97208

www.westernfamily.com

principal display panel

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)

image description

THERAPEUTIC
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55312-205
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	2.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
LAURETH-4 (UNII: 6HQ855798J)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
IMIDUREA (UNII: M629807ATL)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CARAMEL (UNII: T9D99G2B1R)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55312-205-23	130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2011	04/29/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	12/01/2011	04/29/2020

Labeler - Western Family Foods (192166072)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		790752542	manufacture(55312-205)

Revised: 4/2020

Document Id: d9bbd71c-cfeb-417d-9f39-9d4939e51280

Set id: ebe1871b-ce17-44a0-90cb-a5e258c89b0c

Version: 10

Effective Time: 20200430

Western Family Foods

Coal Tar Shampoo205