THERAPEUTIC- coal tar shampoo

Therapeutic by

Drug Labeling and Warnings

Therapeutic by is a Otc medication manufactured, distributed, or labeled by DZA Brands, LLC, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Claims

Healthy Accents

Therapeutic

Shampoo

coal tar

anti-dandruff shampoo

Active ingredients

2.5% Coal Tar Topical Solution USP

(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 throoughly
• massage shampoo into the 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 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 MEA, laureth-4, fragrance, sodium chloride, cocamidopropyl betaine, methylchloroisothiazolinone, methylisothiazolinone, citric acid, tetrasodium EDTA, caramel, red 4

Disclaimer

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

Adverse Reactions

Distributed by: DZA Brands, LLC

Salisbury, NC 28147

Scarborough, ME 0474

For product questions or concerns contact us at 1-866-322-2439.  Please include UPC number and code from package.

205.003/205AH

principal display panel

healthy

accents

therapeutic

shampoo

coal tar

anti-dandruff shampoo

2.5% coal tar topical solution usp

(0.5% coal tar)

compare to the active

ingredient in Neutrogena

Therapeutic T/Gel Shampoo

8.5 FL OZ (251 mL)

INGREDIENTS AND APPEARANCE

THERAPEUTIC 
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
LAURETH-4 (UNII: 6HQ855798J)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
CARAMEL (UNII: T9D99G2B1R)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-205-23	1 in 1 CARTON	05/08/2008
1		251 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	05/08/2008

Labeler - DZA Brands, LLC (090322194)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(55316-205)