THERAPEUTIC- coal tar shampoo 
Topco Associates 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

Active ingredient

2.5% Coal Tar Topical Solution USP (0.5% Coal Tar)

Purpose

Anti-Dandruff

Use

Controls the symptoms of:

Warnings

For external use only

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 Neutrogena Corporation, distributor of Neutrogena T/Gel Shampoo

Adverse Reactions

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007-1015

1-888-423-0139

topcare@topco.com

This product is not manufactured or distributed by Neutrogena T/Gel Shampoo

principal display panel

TopCare beauty

THERAPEUTIC

ANTI-DANDRUFF SHAMPOO

with 2.5% Coal Tar Topical Solution

USP (0.5% Coal tar)

Compare to

NEUTROGENA

T/Gel Shampoo

ORIGINAL STRENGTH

Fights itchy, flaky scalp

Controls the symptoms of dandruff, psoriasis & seborrheic dermatitis

8.5 FL OZ (251 mL)

image description

THERAPEUTIC 
coal tar shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-205
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
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:36800-205-23251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/27/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H12/27/2005
Labeler - Topco Associates LLC (006935977)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(36800-205)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(36800-205)

Revised: 2/2023
Document Id: e709fcf4-b5b5-49d0-b0c0-c417cf032e81
Set id: 53253672-59fb-4e0d-b19f-d81148518e7f
Version: 12
Effective Time: 20230206
 
Topco Associates LLC