FDA.reportPublic FDA data

PC-TAR

Manufacturer
Geritrex LLC
Effective date
2016-07-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:29

Label at a glance#

ProductPC-TAR
Active ingredientCOAL TAR
Label structure7 sections

Indications and uses

To provide temporary relief to itchy, dry, and/or flaky scalp conditions

Dosage and administration

Shake well before using Wet hair and scalp thoroughly Massage shampoo into hair and scalp and work into a rich lather Leave shampoo on hair for several minutes Rinse and repeat Rinse thoroughly with water

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Purpose:

Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis

Intended Uses:

INDICATIONS & USAGE SECTION

To provide temporary relief to itchy, dry, and/or flaky scalp conditions

Directions:

DOSAGE & ADMINISTRATION SECTION

Shake well before using

Wet hair and scalp thoroughly

Massage shampoo into hair and scalp and work into a rich lather

Leave shampoo on hair for several minutes

Rinse and repeat

Rinse thoroughly with water

Warnings:

WARNINGS SECTION

If condition covers a large part of the body, consult a physician before using this product
When using this shampoo protect the treated area from direct sunlight. It may increase your tendency to sunburn for up to 24 hours after using this product.
In rare instances hair discoloration may occur to gray, blonde, bleached, or tinted hair. 
Do not use for prolonged periods without consulting a physician.
If improvement does not occur, or condition worsens after regular use or as directed, consult a physician

FOR EXTERNAL USE ONLY

WARNINGS AND PRECAUTIONS SECTION

In case of accidental ingestion, seek prompt medical attention or contact a Poison Control Center immediately. 
Avoid contact with the eyes. If contact occurs, rinse thoroughly with water.  

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Purified water, Cocamide DEA, Polysorbate 20 & 80, Cocamphocarboxy Glyceride, EDTA, Fragrance, Magnesium Aluminum Silicate, PEG-75 Lanolin, Hexeylene Glycol, Sodium Polnapthalene Sulfonate, 0.5% Parachlorometaxylenol (antimicrobial preservative)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309402coal tar 1 % Medicated ShampooPSN1
309402coal tar 10 MG/ML Medicated ShampooSCD1
309402coal tar 1 % Medicated ShampooSY1
309402crude coal tar 1 % (coal tar solution 5 % ) Medicated ShampooSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54162-200-062020-01-31C16284748780-19d75b9d0-409c-f424-e053-dadaa90a57cePC-TAR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54162-200-06PC-TAR177.441 mL in 1 BOTTLESHAMPOO177.4411

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54162-200PC-TAR (COAL TAR) SHAMPOO [GERITREX LLC]1Legacy NDC, 1 package rows20160705_36eb2fe8-4e14-41e2-ade2-7687955c8db6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54162-200-06ML - Milliliter54162-200c4520cd9-397c-4115-9b7a-0245cdcd57ac12016-07-19

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54162-20054162-200-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
COAL TARR533ESO2ECACTIB
WATER059QF0KO0RIACT
COCAMIDE3YXD33R71GIACT
POLYSORBATE 207T1F30V5YHIACT
POLYSORBATE 806OZP39ZG8HIACT
EDETIC ACID9G34HU7RV0IACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
PEG-75 LANOLIN09179OX7TBIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
NAPHTHALENESULFONIC ACID (MIXED ISOMERS)VZW67VII75IACT
CHLOROXYLENOL0F32U78V2QIACT

Source Document#

Source XML

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
fea138a7-b4da-45c8-bd53-815bc27aabea36eb2fe8-4e14-41e2-ade2-7687955c8db62016-07-05WarningsExact identifier
spl id: fea138a7-b4da-45c8-bd53-815bc27aabea
spl set id: 36eb2fe8-4e14-41e2-ade2-7687955c8db6

Reported adverse events (FAERS/openFDA)#

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