THERAPEUTIC- coal tar shampoo

Therapeutic by

Drug Labeling and Warnings

Therapeutic by is a Otc medication manufactured, distributed, or labeled by Vi-Jon, Inc.. 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 symoptoms 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 occurrs, 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 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.

California Proposition 65 Warning

This product contains chemicals know in the State of California to cause cancer.

Directions

• for best results use at least twice a week or as directed by a doctor
• wet hair thoroughly
• massage shampoo into 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 MIPA, cocamidipropl betaine, polysorbate 20, laureth-4, bishydroxyethly dihydroxypropyl stearammonium chloride,  PEG-120 methyl glucose dioleate, tetrasodium EDTA, citric acid, fragrance, imidazolidinyl urea, methylparaben, propylparaben, caramel, red-4

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by the Neutorgena T/Gel Therapeutic Shampoo Extra Strength.

Manufactured by:  Vi-Jon, Inc., St. Louis, MO 63114

Questions or Comments? 1-888-593-0593

Principal display panel

Mountain falls

Compare to Neutrogena*

Fights itchy, flaky scalp

Leaves hair shiny and manageable

Gentle fragrance

Controls the symptoms of:

• psoriasis
• seborrheic dermatitis
• dandruff

Therapeutic dandruff shampoo

5% coal tar topical solution USP (1% coal tar)

Extra strength

6 FL OZ (177 mL)

850.002/850AC-497AF

INGREDIENTS AND APPEARANCE

THERAPEUTIC 
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0869-0850
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	1.02 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)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CARAMEL (UNII: T9D99G2B1R)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0869-0850-30	1 in 1 CARTON	12/01/2017
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	12/01/2017

Labeler - Vi-Jon, Inc. (790752542)

Registrant - Vi-Jon, Inc. (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc.		790752542	manufacture(0869-0850)