THERAPEUTIC DANDRUFF- coal tar shampoo

Therapeutic Dandruff by

Drug Labeling and Warnings

Therapeutic Dandruff by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Vi-Jon. 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

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 prescription dugs 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.

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 MIPA, laureth-4, fragrance, cocamidopropyl betaine, citric acid, sodium chloride, tetrasodium EDTA, methylparaben, propylparaben, imidazolidinyl urea, caramel, red 4

Questions

Call 1-800-748-3243

SPL UNCLASSIFIED SECTION

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*This product is not manufactured or distributed by the Neutorgena Corp., distributor of Neutrogena T/Gel Therapeutic Shampoo

MADE IN THE U.S.A. WITH FOREIGN AND DOMESTIC COMPONENTS

DISTRIBUTED BY: RITE AID

30 HUNTER LANE

CAMP HILL, PA 17011

principal display panel

daylogic

COAL TAR therapeutic DANDRUFF SHAMPOO

ORIGINAL STRENGTH

Controls the Symptoms of Dandruff, Psoriasis & Seborrheic Dermatitis

With 2.5% Coal Tar Topical Solution USP

(0.5% Coal Tar)

Compare to Neutrogena T/Gel

16 FL OZ (473mL)

INGREDIENTS AND APPEARANCE

THERAPEUTIC DANDRUFF 
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-9973
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)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
IMIDUREA (UNII: M629807ATL)
CARAMEL (UNII: T9D99G2B1R)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-9973-0	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/13/2009
2	NDC: 11822-9973-1	251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/13/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	05/13/2009

Labeler - Rite Aid (014578892)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(11822-9973)