THERAPEUTIC PLUS- coal tar shampoo
C.D.M.A., INC

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.

----------

Quality Choice 205.003/205AG/AH

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

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 rediation or prescription dugs 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 leat 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 Neutrgena Corporation, distributor of Neutrogena T/Gel Shampoo

Adverse Reactions

Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MIO 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

205.003/205AH

principal display panel

QUALITY

CHOICE

Compare to

NEUTROGENA

Therapeutic T/Gel

Shampoo

Therapeutic

T-Plus

Dandruff Shampoo

Coal Tar Dandruff Shampoo

Original Strength

Controls Symptoms of:

Psoriasis

Seborrheic Dermatitis

Dandruff

Fights:

Itchy, Flaky Scalp

2.5% Coal Tar Topical Solution USP

(0.5% Coal Tar)

16 FL OZ (1 PT) 473 mL

image description

THERAPEUTIC PLUS
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-205
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63868-205-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/26/2004	02/08/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	05/26/2004	02/08/2021

Labeler - C.D.M.A., INC (011920774)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(63868-205)

Revised: 2/2021

Document Id: fcc8a1ed-b0cd-4779-af61-708d90a5f209

Set id: bc2c096d-7694-4765-9e6b-8ced5ce5afa0

Version: 6

Effective Time: 20210209

C.D.M.A., INC