THERAPEUTIC- coal tar shampoo

Therapeutic by

Drug Labeling and Warnings

Therapeutic by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

5% Coal tar topical solution USP (1% Coal Tar)

Purpose

Anti-dandruff, Anti-seborrheic dermatitis, Anti-psoriasis

Use

Controls the symptoms of:

• dandruff
• seborrheic dermatitis
• psoriasis

Warnings

For external use only

Ask a doctor before use if you have

a condtion 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 sue 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 reqular 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

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

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 MEA, cocamidopropyl betaine, polysorbate 20, laureth-4, bis-hydroxyethyl dihydroxypropyl stearammonium chloride, PEG-120 methyl glucose dioleate, tetrasodium EDTA, citric acid, methylchloroisothiazolinone, methylisothiazolinone, fragrance, caramel, red 4

SPL UNCLASSIFIED SECTION

CVS/pharmacy Extra Strength Therapeutic Dandruff Shampoo controls redness, itching and flaking caused by severe scalp conditions. Our active ingredient continues to provide effective scalp therapy even after you rinse.
Leaves hair shiny and manageable
Safe for regular use as directed

*This product is not manufactured or distributed by the Neutorgena Corporation, distributor of the registered trademark Neutrogena T/Gel.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

2016 CVS/pharmacy

CVS.com 1-800-SHOP-CVS

Made in the U.S.A. with U. S. and foreign components

Principal display panel

CVS Health

Compare to Neutrogena T/Gel Therapeutic Shampoo*

EXTRA STRENGTH

Therapeutic Dandruff Shampoo

5% COAL TAR TOPICAL SOLUTION USP (1% COAL TAR)

Controls redness, intense itching & flaking of severe scap conditions

Controls the symptoms of dandruff, seborrheic dermatitis & psoriasis

6 FL OZ (177 mL)

497.002/497AG

INGREDIENTS AND APPEARANCE

THERAPEUTIC 
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-497
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	10.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LAURETH-4 (UNII: 6HQ855798J)
BISHYDROXYETHYL DIHYDROXYPROPYL STEARAMMONIUM CHLORIDE (UNII: 32II08O72A)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
IMIDUREA (UNII: M629807ATL)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CARAMEL (UNII: T9D99G2B1R)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-497-30	1 in 1 CARTON	05/05/2009
1		177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	05/05/2009

Labeler - CVS Pharmacy, Inc (062312574)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(59779-497)