FDA.reportPublic FDA data

True Plus Real Therapeutic T PLUS EXTRA STRENGTH COAL TAR TAR DANDRUFF

Manufacturer
Garcoa, Inc. | Sigan America, LLC
Effective date
2024-05-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:17:01

Label at a glance#

ProductTrue Plus Real Therapeutic T PLUS EXTRA STRENGTH COAL TAR TAR DANDRUFF Anti-dandruff, anti-seborrheic dermatitis, ant...
Active ingredientCOAL TAR
Label structure11 sections

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Solubilized Coal Tar Extract 5.00% (Coal Tar, 1.00%)

Purpose

OTC - PURPOSE SECTION

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

Use

INDICATIONS & USAGE SECTION

controls the symptom of:

  • dandruff
  • seborrheic dermatitis
  • psoriasis

Warnings

WARNINGS SECTION

For external use only.

OTC - ASK DOCTOR SECTION

Ask a doctor before using this product if condition covers a large area of the body.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the 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 for 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 use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING 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, cocamidopropyl betaine, cocamide MEA, laureth-4, polysorbate 20, bis-hydroxyethyl dihydroxypropyl stearammonium chloride, PEG-120 methyl glucose dioleate, disodium EDTA, citric acid, phenoxyethanol, fragrance, methylchloroisothiazolinone, methylisothiazolinone, red 40, blue 1, yellow 5, yellow 6, sodium chloride.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-567-8600

SPL UNCLASSIFIED SECTION

Distributed by:
True+Real™ Products
Calabasas, CA 91302

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

True+Real™

THERAPEUTIC
T+PLUS
EXTRA STRENGTH

COAL TAR 1.00%
TAR GEL DANDRUFF
SHAMPOO

Controls the symptoms of
dandruff, seborrheic
dermatitis and psoriasis

For the relief of scalp itching
and flaking

FLAKE FREE
ANTI-DANDRUFF

6 FL OZ (177 mL)

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309402coal tar 1 % Medicated ShampooPSN2
309402coal tar 10 MG/ML Medicated ShampooSCD2
309402coal tar 1 % Medicated ShampooSY2
309402crude coal tar 1 % (coal tar solution 5 % ) Medicated ShampooSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67385-260-01True Plus Real Therapeutic T PLUS EXTRA STRENGTH COAL TAR TAR DANDRUFFAnti-dandruff, anti-seborrheic dermatitis, anti-psoriasis177 mL in 1 BOTTLESHAMPOO1772

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67385-26067385-260-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
COAL TARR533ESO2ECACTIB
Water059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
Cocamidopropyl Betaine5OCF3O11KXIACT
COCO MONOETHANOLAMIDEC80684146DIACT
Laureth-46HQ855798JIACT
Polysorbate 207T1F30V5YHIACT
Bis-Hydroxyethyl Dihydroxypropyl Stearammonium Chloride32II08O72AIACT
PEG-120 Methyl Glucose DioleateYM0K64F20VIACT
EDETATE DISODIUM7FLD91C86KIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PhenoxyethanolHIE492ZZ3TIACT
MethylchloroisothiazolinoneDEL7T5QRPNIACT
Methylisothiazolinone229D0E1QFAIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
Sodium Chloride451W47IQ8XIACT

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
True Plus Real Therapeutic T PLUS EXTRA STRENGTH COAL TAR TAR DANDRUFF Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARGarcoa, Inc.20116e1e-56f1-4018-99ef-758de7fc24642024-05-10WarningsExact identifier
ndc (package): 67385-260-01
ndc (product): 67385-260
ndc11 (package): 67385026001
spl id: 2be54bc2-c37c-43bc-9ed2-0103bcf3d880
spl set id: 20116e1e-56f1-4018-99ef-758de7fc2464

Reported adverse events (FAERS/openFDA)#

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