THERAPEUTIC- coal tar shampoo 
DZA Brands, LLC

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

Healthy Accents

Therapeutic

Shampoo

coal tar

anti-dandruff shampoo

Active ingredients

2.5% Coal Tar Topical Solution USP

(0.5% Coal Tar)

Purpose

Anti-dandruff

Use

Controls the symptoms of:

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

Stop use and ask a doctor if

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

other information

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

Disclaimer

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

Adverse Reactions

Distributed by: DZA Brands, LLC

Salisbury, NC 28147

Scarborough, ME 0474

For product questions or concerns contact us at 1-866-322-2439.  Please include UPC number and code from package.

Principal Display Panel

healthy

accents

therapeutic

shampoo

coal tar

anti-dandruff shampoo

2.5% coal tar topical solution usp

(0.5% coal tar)

controls the symptoms of:

psoriasis, seborrheic dermatitis + dandruff

compare to the active ingredient in Neutrogena Therapeutic T/Gel Shampoo

8.5 FL OZ (251 mL)

image description

THERAPEUTIC 
coal tar shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55316-205
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 5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
LAURETH-4 (UNII: 6HQ855798J)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
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:55316-205-23 1 in 1 CARTON
1 251 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 05/08/2008
Labeler - DZA Brands, LLC (090322194)
Registrant - Vi-Jon (790752542)
Establishment
Name Address ID/FEI Business Operations
Vi-Jon 790752542 manufacture(55316-205)

Revised: 10/2013
Document Id: 71155d60-187b-4722-8332-d38f0ec5279e
Set id: 7f81698e-c656-46f8-8baa-a14c9602bb07
Version: 2
Effective Time: 20131016
 
DZA Brands, LLC