Therapeutic Anti-Dandruff by Big Lots / Vi-Jon Drug Facts

Therapeutic Anti-Dandruff by

Drug Labeling and Warnings

Therapeutic Anti-Dandruff by is a Otc medication manufactured, distributed, or labeled by Big Lots, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

THERAPEUTIC ANTI-DANDRUFF- coal tar shampoo 
Big Lots

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.

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Drug Facts

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 radiation or prescriptin 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

Questions

Call 1-888-593-0593

Disclaimer

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

Adverse Reactions

Manufactured for Big Lots by: Vi-Jon, Inc

8515 Page Avenue; St. Louis, MO 63114

V#425040 Item #000

MADE IN THE USA with US AND Foreign Components

205.003/205AH

principal display panel

SOUND

BODY

COMPARE TO NEUTROGENA

THERAPEUTIC

T/GEL SHAMPOO

Therapeutic

Shampoo

ANTI-DANDRUFF SHAMPOO

2.5% Coal Tar

Topica Solution USP

(0.5% Coal Tar)

Controls the symptoms of:

• Psoriasis
• Seborrheic Dermatitis
• Dandruff
• Fights itchy, flaky scalp
• Gentle fragrance

Leaves hair shiny and manageable

8.5 FL OZ (251 mL)

THERAPEUTIC ANTI-DANDRUFF 
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50594-205
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: 50594-205-69	1 in 1 CARTON	03/18/2016	04/14/2020
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	03/18/2016	04/14/2020

Labeler - Big Lots (017885351)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(50594-205)

Revised: 4/2020

Document Id: 137caf3a-0c36-4d47-be6d-8efaf1765978

34390-5

Set id: 48be89d4-0427-4068-9112-3cd047f6c061

Version: 4

Effective Time: 20200414

 

Big Lots