FDA.reportPublic FDA data

Therapeutic

Manufacturer
CVS Pharmacy, Inc. | Consumer Product Partners, LLC
Effective date
2024-08-07
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
legacy-cache
Hydrated at
2026-08-01 20:57:04

Label at a glance#

ProductTherapeutic
Active ingredientCOAL TAR
Label structure14 sections

Dosage and administration

for best results use at least twice a week or as directed by a doctor wet hair thoroughly masage shampoo into scalp lather. Leave on hair and scalp for several minutes rinse and repeat

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

5% Coal Tar Topical Solution USP (1% Coal Tar)

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Use

INDICATIONS & USAGE SECTION

controls the symoptoms of:

  • dandruff
  • seborrheic dermatitis
  • psoriasis

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

a condition which covers a large part of the body

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

condition worsens or does not improve after reqular use of this product as directed.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

California Proposition 65 Warning

OTHER SAFETY INFORMATION

This product contains chemicals know in the State of California to cause cancer.

Directions

DOSAGE & ADMINISTRATION SECTION

  • for best results use at least twice a week or as directed by a doctor
  • wet hair thoroughly
  • masage shampoo into scalp
  • lather. Leave on hair and scalp for several minutes
  • rinse and repeat

Other information

SPL UNCLASSIFIED SECTION

  • store away from direct sunlight
  • in rare instances, discoloration of gray, blonde, bleached or tinted hair may occur

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by the Johnson & Johnson Corporation, owner of the registered trademark Neutrogena T/Gel.

Distributed by: CVS Pharmacy, Inc.

One CVS/pharmacy

CVS.com 1-800-SHOP-CVS

Made in the U.S.A. with U.S. and foreign compents.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health

Compare to Neutrogena T/Gel Therapeutic Shampoo*

EXTRA STRENGTH

Therapeutic Dandruff Shampoo

5% COAL TAR TOPICAL SOLUTION USP (1% COAL TAR)

Controls redness, intense itching & flaking of severe scalp conditions

Controls the symptoms of dandruff, sevorrheic dermatitis & psoriasis

6 FL OZ (177 mL)

image descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-850THERAPEUTIC (COAL TAR) SHAMPOO [CVS PHARMACY, INC.]13Legacy NDC20240809_db9941fd-8861-4e8c-b564-cc01cf3abb82.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59779-85059779-850-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCO MONOISOPROPANOLAMIDE21X4Y0VTB1IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
POLYSORBATE 207T1F30V5YHIACT
LAURETH-46HQ855798JIACT
BISHYDROXYETHYL DIHYDROXYPROPYL STEARAMMONIUM CHLORIDE32II08O72AIACT
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
EDETATE SODIUMMP1J8420LUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
IMIDUREAM629807ATLIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
CARAMELT9D99G2B1RIACT
FD&C RED NO. 4X3W0AM1JLXIACT
COAL TARR533ESO2ECACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3debd414-143d-69d3-e063-6394a90a7184db9941fd-8861-4e8c-b564-cc01cf3abb822025-09-03WarningsExact identifier
spl set id: db9941fd-8861-4e8c-b564-cc01cf3abb82

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.