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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Coal Tar Shampoo
205.004/205AH

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 MEA, laureth-4, fragrance, sodium chloride, cocamidopropyl betaine, methylchloroisothiazolinone, methylisothiazolinone, citric acid, tetrasodium EDTA, 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)

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-205
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
LAURETH-4 (UNII: 6HQ855798J)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CARAMEL (UNII: T9D99G2B1R)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-205-231 in 1 CARTON05/08/2008
1251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H05/08/2008
Labeler - DZA Brands, LLC (090322194)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(55316-205)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(55316-205)

Revised: 2/2023
Document Id: 4a18e503-48f8-447a-bff0-dcd0d2bdb50f
Set id: 7f81698e-c656-46f8-8baa-a14c9602bb07
Version: 22
Effective Time: 20230206
 
DZA Brands, LLC