THERAPEUTIC- coal tar shampoo 
Rite Aid

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

Claims

RITE

AID

RENEWAL

therapeutic

SHAMPOO

Active ingredient

Active ingredient

5% Coal Tar Topical Solution USP

(1% Coal Tar)

Purpose

Purpose

Anti-dandruff

Use

Use controld the symoptoms of:

Warnings

Warnings

For external use only

Ask a doctor

Ask a doctor before use if you have a condition which covers a large part of the body

When using this product

When using this product

Stop use

Stop use and ask a doctor if condition worsend or does not improve after reqular use of this product as directed.

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

Directions

Other information

Other information

Inactive ingredients

Inactive ingredients water, sodium laureth sulfate, cocamide DEA, cocamidipropl betaine, laureth-4, PEG-120 methyl glucose dioleate, polysorbate 20, fragrance, citric acid, imidazolidlhyl urea, bishydroxyethly dihydroxypropyl stearammonium chloride, tetrasodium EDTA, methylparaben, propylparaben, caramel, red-4

Disclaimer

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

Adverse reactions

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

Side panel claims

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

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)

image description

THERAPEUTIC 
coal tar shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0497
Route of Administration TOPICAL DEA Schedule     
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 DIETHANOLAMIDE (UNII: 92005F972D)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
LAURETH-4 (UNII: 6HQ855798J)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
IMIDUREA (UNII: M629807ATL)  
EDETATE SODIUM (UNII: MP1J8420LU)  
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:11822-0497-6 1 in 1 CARTON
1 177 mL in 1 BOTTLE, PLASTIC
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)

Revised: 1/2013
Document Id: 29c6e910-23ee-4d66-aa5b-6b2c083728c3
Set id: 406c424a-77a0-43d5-9246-8c67f838ba97
Version: 1
Effective Time: 20130110
 
Rite Aid