FDA.reportPublic FDA data

TARSUM PROFESSIONAL

Manufacturer
Summers Laboratories Inc
Effective date
2023-10-09
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 23:56:37

Label at a glance#

ProductTARSUM PROFESSIONAL
Active ingredientCOAL TAR
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

CONTAINS

2% COAL TAR

(10% LCD EQUIV. TO 2% COAL TAR)

OTC - PURPOSE SECTION

PURPOSE

PSORIASIS, SEBORRHEIC DERMATITIS, DANDRUFF TREATMENT

INDICATIONS & USAGE SECTION

USE

  • CONTROLS ITCHING, FLAKING AND REDNESS DUE TO PSORIASIS, SEBORRHEIC DERMATITIS AND DANDRUFF

WARNINGS SECTION

WARNINGS

FOR EXTERNAL USE ONLY

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • condition that covers a large area of the body
  • condition in or around the rectum or genitals

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes. If contact occurs rinse eyes thoroughly with water.
  • use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn up to 24 hours after application.
  • do not use for prolonged periods without consulting a doctor.
  • do not use this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor.

OTC - STOP USE SECTION

Stop and ask a doctor if

  • condition worsens or does not improve after regular use as directed
  • excessive irritation occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTCT A POISON CONTROL CENTER RIGHT AWAY.

OTHER SAFETY INFORMATION

Other information

In rare instances, temporary discoloration of gray or blonde hair may occur.

DOSAGE & ADMINISTRATION SECTION

Directions

  • For use as a scalp treatment before showering: Twist open applicator tip. Apply evenly to affected areas. Leave on for 5 minutes, gradually increasing treatment time to 1 hour, or as directed by your doctor. Rinse thoroughly.
  • As a shampoo: Wet hair, apply Tarsum for several minutes, then rinse.
  • For best results use twice a week or as directed by a physician.

INACTIVE INGREDIENT SECTION

Inactive ingredients

water, TEA lauryl sulfate, cocamide DEA, sodium lauryl sulfate, ethanol (8%), salicylic acid, triethanolamine, glycerin, lauryl alcohol, diethanolamine, sodium chloride, polysorbate 80, fragrance

OTHER SAFETY INFORMATION

Store at controlled room temperature

59° to 86° F (15° to 30° C)

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-800-533-7546 (USA and Canada)

For more information go to www.sumlab.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tarsum 4oz_Unit CartonTarsum 4oz_Unit Carton

Tarsum 8 oz_LabelTarsum 8 oz_Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204836crude coal tar 2 % Medicated ShampooPSN9
1997161TARSUM 2 % Medical ShampooPSN9
1997161coal tar 20 MG/ML Medicated Shampoo [Tarsum Reformulated]SBD9
204836coal tar 20 MG/ML Medicated ShampooSCD9
204836crude coal tar 2 % (coal tar solution 10 % ) Medicated ShampooSY9
1997161Tarsum Reformulated 20 MG/ML Medicated ShampooSY9

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11086-011-012025-01-30C16284748780-12cef2736-6c32-d83d-e063-dadaa90ab31fSUMMERS LABS (as PLD) - TARSUM (11086-011)
11086-011-022025-01-30C16284748780-12cef2736-6c32-d83d-e063-dadaa90ab31fSUMMERS LABS (as PLD) - TARSUM (11086-011)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11086-011-01TARSUM PROFESSIONAL118 mL in 1 BOTTLESHAMPOO1189
11086-011-02TARSUM PROFESSIONAL236 mL in 1 BOTTLESHAMPOO2369

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11086-011TARSUM PROFESSIONAL (COAL TAR) SHAMPOO [SUMMERS LABORATORIES INC]9Legacy NDC, 2 package rows20231011_d990a3d8-8be8-44e3-8e84-a6d8da21f3b5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11086-011-01ML - Milliliter11086-011c42d1ce9-1977-4f11-8df2-429674f74f9b12013-12-02
11086-011-02ML - Milliliter11086-011e8e72cbd-3b2d-46a6-86b3-02a7640be92512013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
COAL TARACTIVE INGREDIENTR533ESO2EC3
COAL TARACTIVE MOIETYR533ESO2EC3
ALCOHOLINACTIVE INGREDIENT3K9958V90M3
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972D3
DIETHANOLAMINEINACTIVE INGREDIENTAZE05TDV2V3
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
LAURYL ALCOHOLINACTIVE INGREDIENT178A96NLP23
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H3
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZ3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J3
TRIETHANOLAMINE LAURYL SULFATEINACTIVE INGREDIENTE8458C1KAA3
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11086-01111086-011-01, 11086-011-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
TRIETHANOLAMINE LAURYL SULFATEE8458C1KAAIACT
COCO DIETHANOLAMIDE92005F972DIACT
SODIUM LAURYL SULFATE368GB5141JIACT
ALCOHOL3K9958V90MIACT
SALICYLIC ACIDO414PZ4LPZIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
LAURYL ALCOHOL178A96NLP2IACT
DIETHANOLAMINEAZE05TDV2VIACT
SODIUM CHLORIDE451W47IQ8XIACT
POLYSORBATE 806OZP39ZG8HIACT
COAL TARR533ESO2ECACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 420 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGEL / DENTAL1.47 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / ORAL148 mgExact identifier — unii candidate
134 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, FILM COATED / ORAL100 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, EXTENDED RELEASE / ORAL166 mgExact identifier — unii candidate
42 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRASYNOVIAL0.2 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / PERIDURAL8.07 mgExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / OPHTHALMIC1 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL34 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HGEL / TOPICAL12 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / RESPIRATORY (INHALATION)1 mgExact identifier — unii candidate
78 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / INTRAMUSCULAR17 mgExact identifier — unii candidate
134 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM, AUGMENTED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSHAMPOO / TOPICAL150 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRA-ARTICULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSPONGE / TOPICAL5 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS900 mgExact identifier — unii candidate
78 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET / SUBLINGUAL0.08 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRA-ARTICULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGRANULE, FOR SUSPENSION / ORAL162 mgExact identifier — unii candidate
134 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL11 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, CHEWABLE / ORAL20 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HELIXIR / ORAL2.5 mg/15mlExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, DENTIFRICE / DENTAL0.03 mg/mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSYRUP / ORAL40 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, DELAYED RELEASE / ORAL46 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JDROPS / ORALNAExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCAPSULE, EXTENDED RELEASE / ORAL41 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, FOR SUSPENSION / ORAL98 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRATHECAL1.35 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSPRAY / NASAL30 mgExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
42 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAVENOUS90 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / PARENTERAL584 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGEL / OPHTHALMIC0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, FILM COATED / ORAL240 mgExact identifier — unii candidate
42 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
78 equally ranked IID candidates

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
074cfb96-7002-5f8d-e063-6394a90af30bd990a3d8-8be8-44e3-8e84-a6d8da21f3b52023-10-09WarningsExact identifier
spl id: 074cfb96-7002-5f8d-e063-6394a90af30b
spl set id: d990a3d8-8be8-44e3-8e84-a6d8da21f3b5

Reported adverse events (FAERS/openFDA)#

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