THERAPEUTIC- coal tar shampoo

Therapeutic by

Drug Labeling and Warnings

Therapeutic 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

5% Coal Tar Topical Solution USP

(1% Coal Tar)

Purpose

Anti-dandruff

Use control the symoptoms of:

• dandruff
• seborrheic dermatitis
• psoriasis

WARNINGS

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.

Directions

• for best results use at least twice a week or as directed b a doctor
• wet hair thoroughly
• masage 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 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

ADVERSE REACTIONS

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

RITE AID
therapeutic shampoo extra strength
Controls redness, Intense Itching + Flaking of Severe Scalp Conditions
Controls Symptoms of: Dandruff, Psoriasis + Seborrheic Dermatitis
Coal Tar Anti-Dandruff Shampoo

RITE AID RENEWAL THERAPEUTIC SHAMPOO

DISTRIBUTED BY:

RITE AID, 30 HUMTER LANE

CAMP HILL, PA 17011

MADE IN THE USA

This product is not labeled for sale in the state of California

Principal Display Panel

Compare to the active ingredient of Neutogena T/Gel Therapeutic Shampoo*

RITE AID RENEWAL

therapeutic 

SHAMPOO EXTRA STRENGTH 

Controls Redness, Intense Itching + Flaking of Severe Scalp Conditions

Controls Symptoms of: Dandruff, Psoriasis + Seborrheic Dermatitis

Coal Tar Anti-Dandruff Shampoo

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: 11822-0497
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)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
BISHYDROXYETHYL DIHYDROXYPROPYL STEARAMMONIUM CHLORIDE (UNII: 32II08O72A)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
EDETATE SODIUM (UNII: MP1J8420LU)
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: 11822-0497-6	1 in 1 CARTON	02/14/2011
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	02/14/2011

Labeler - Rite Aid (014578892)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(11822-0497)