THERAPEUTIC- coal tar shampoo

Therapeutic by

Drug Labeling and Warnings

Therapeutic by is a Otc medication manufactured, distributed, or labeled by Western Family Foods, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

Purpose
Anti-Dandruff

INDICATIONS & USAGE

Use controls the symptoms of:
dandruff seborrheic dermatitis psoriasis

WARNINGS

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.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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

INACTIVE INGREDIENT

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

ADVERSE REACTIONS

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

SPL UNCLASSIFIED SECTION

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

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)

INGREDIENTS AND APPEARANCE

THERAPEUTIC 
coal tar shampoo

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	2.5 mL  in 100 L

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55312-205-23	.251 L in 1 BOTTLE, PLASTIC

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

Labeler - Western Family Foods (192166072)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture