THERAPEUTIC- coal tar shampoo

Therapeutic by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

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

When using this product

• do not get into eyes.  If contact occurs, rinse eyes thoroughly wih water.
• use caution in exposing skin to sunlight after applying this product.  It may increase 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 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 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 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 Neutrogena Corporation, distributor of Neutrogena T/Gel Shampoo

Adverse Reactions

DISTRIBUTED BY TOPCO ASSOCIATES LLC

150 NORTHWEST POINT BLVD.

ELK GROVE BILLAGE, IL 60007-1015

1-888-423-0139

topcare@topco.com

205.003/205AH

principal display panel

Top Care beauty

THERAPEUTIC 

ANTI-DANDRUFF

SHAMPOO

with 2.5% Coal Tar

Topical Solution

UP (0.5% Coal Tar)

Compare to

NEUTROGENA

T/Gel Shampoo

ORIGINAL STRENGTH

Fights itchy, flaky scalp

Controls the symptoms

of dandruff, psoriasis &

seborrheic dermatitis

8.5 FL OZ (251 mL)

INGREDIENTS AND APPEARANCE

THERAPEUTIC 
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
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: 36800-205-23	251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/27/2005

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	12/27/2005

Labeler - Topco Associates LLC (006935977)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(36800-205)