THERAPEUTIC- coal tar shampoo

Therapeutic by

Drug Labeling and Warnings

Therapeutic by is a Otc medication manufactured, distributed, or labeled by Wal-Mart, Vi-Jon, LLC. 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 symptoms of:

• dandruff
• seborrheic dermatitis
• psoriasis

WARNINGS

Warnings

For external use only

Ask a doctor before use

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

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

• for best results use at least twice a week or as directed by a doctor
• wet hair thoroughly
• massage shampoo into the 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 MEA, cocamidopropyl betaine, polysorbate 20, laureth-4, bis-hydroxyethyl dihydroxypropyl stearammonium chloride, PEG-120 methyl glucose dioleate, tetrasodium EDTA, citric acid, methylchloroisothiazolinone, methylisothiazolinone, fragrance, caramel, red 4

Questions or comments?

Call: 1-888-287-1915

SPL UNCLASSIFIED SECTION

Benefits

Equate Therapeutic Shampoo helps to control the scalp itching and flaking caused by chronic scalp psoriasis, seborrheic dermatitis and common dandruff. The active ingredient in EquateTherapeutic Shampoo continues to work even after hair has been rinsed.

The clear formula is formulated to be pleasant to use and gentle on hair. This uniquely formulated shampoo is gentle and safe for regular use as directed. The luxuriously rich lather has a fresh scent and will leave your hair shiny and manageable.

This product is not manufactured or distributed byNeutrogena Corporation, Distributor of T/Gel Shampoo
This product is not labeled for sale in the State of California

Distributed by: Wal-Mart Stores Inc.
Bentonville, AR 72216

Principal Display panel

NDC: 49035-497-30

Equate

Compare to Neutrogneia T/Gel Therapeutic Shampoo Extra Strength*

Extra Strength Anti-Dandruff Formula Therapeutic Shampoo

5% Coal Tar Topical Solution USP (1% Coal Tar)

Long-Lasting Relief for Itchy, Flaky Scalp

• Keeps working even after hair has been rinsed
• Controls symptoms of dandruff, psoriasis and seborrheic dermatitis
• Transparent formula
• Gentle Fragrance

6 FL OZ (177 mL)

497.002/497AG

INGREDIENTS AND APPEARANCE

THERAPEUTIC 
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-497
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 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LAURETH-4 (UNII: 6HQ855798J)
BISHYDROXYETHYL DIHYDROXYPROPYL STEARAMMONIUM CHLORIDE (UNII: 32II08O72A)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CARAMEL (UNII: T9D99G2B1R)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-497-30	1 in 1 PACKAGE	08/31/2011
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	08/31/2011

Labeler - Wal-Mart (051957769)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(49035-497)