FDA.reportPublic FDA data

THERAPEUTIC

Manufacturer
Mediceutical Laboratories, LTD
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:47:04

Label at a glance#

ProductTHERAPEUTIC
Active ingredientPYRITHIONE ZINC
Label structure8 sections

Indications and uses

HELPS CONTROL AND PREVENT FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITUS.

Dosage and administration

For best results use daily or until conditionis iunder control or as directed by a physician.  For maximum control use every time you shampoo. Cleanse with appropriate Mediceuticals® shampoo Work ample amount of Therapeutic TM Scalp and Hair Treatment Rinse evenly through hair, gently massage onto the scalp, leave on 1-2 minutes Thoroughly rinse Consult your Salon professional for additional Mediceuticals® scalp a...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 1%

Purpose

OTC - PURPOSE SECTION

anti-dandruff, anti-seborrheic, dermatitis

Uses

INDICATIONS & USAGE SECTION

HELPS CONTROL AND PREVENT FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITUS.

Warnings

WARNINGS SECTION

For external use only. If condition worsens or does not improve after regular use of this product as directed, discontinue and consult a physician. If condition covers a large area of the body, consult your physician before using this product.

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with cool water.

Keep this and all drugs 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.

Directions

DOSAGE & ADMINISTRATION SECTION

For best results use daily or until conditionis iunder control or as directed by a physician.  For maximum control use every time you shampoo.

  1. Cleanse with appropriate Mediceuticals® shampoo
  2. Work ample amount of Therapeutic TM Scalp and Hair Treatment Rinse evenly through hair, gently massage onto the scalp, leave on 1-2 minutes
  3. Thoroughly rinse

Consult your Salon professional for additional Mediceuticals® scalp and hair treatment specifically tailored for your condition.

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER (AQUA), BEHENTRIMONIUM METHOSULFATE, CETEARYL ALCOHOL, CETYL ALCOHOL, PHENOXYETHANOL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, HUMULUS LUPULUS (HOPS) EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, HYDRASTIS CANADENSIS (GOLDENSEAL) EXTRACT, HAMAMELIS VIRGINIANA (WITCH hAZEL) LEAF EXTRACT, ASCORBIC ACID, ETHYLHEXYL METHOXYCINNAMATE, TETRASODIUM EDTA, MENTHOL, GINKGO BILOBA, FRAGRANCE (PARFUM), BLUE 1 (CI 42090).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Therapeutic 250ml_FrontTherapeutic 250ml_FrontTherapeutic 250ml_BackTherapeutic 250ml_Back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN4
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD4
209884zinc pyrithione 1 % Medicated ConditionerSY4
209884zinc pyrithione 1 % Medicated ShampooSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59279-515-122024-01-30C16284748780-11030e365-2b0e-111a-e063-dadaa90a10e2Mediceutical Laboratories - THERAPEUTIC SCALP & HAIR TREATMENT RINSE (59279-515)
59279-515-332024-01-30C16284748780-11030e365-2b0e-111a-e063-dadaa90a10e2Mediceutical Laboratories - THERAPEUTIC SCALP & HAIR TREATMENT RINSE (59279-515)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59279-515-12THERAPEUTIC250 mL in 1 BOTTLE, PLASTICRINSE2504
59279-515-33THERAPEUTIC1000 mL in 1 BOTTLE, PLASTICRINSE10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59279-515THERAPEUTIC (ZINC PYRITHIONE) RINSE [MEDICEUTICAL LABORATORIES, LTD]4Legacy NDC, 2 package rows20220116_db1dfe98-6eba-4dc1-a11a-845fe19ddc61.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59279-51559279-515-33, 59279-515-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BEHENTRIMONIUM CHLORIDEX7GNG3S47TIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
HOPS01G73H6H83IACT
ROSEMARYIJ67X351P9IACT
GOLDENSEALZW3Z11D0JVIACT
WITCH HAZEL101I4J0U34IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
OCTINOXATE4Y5P7MUD51IACT
EDETATE SODIUM TETRAHYDRATEL13NHD21X6IACT
MENTHOLL7T10EIP3AIACT
GINKGO BILOBA WHOLE660486U6OIIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB

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
d580ee94-9382-1177-e053-2a95a90a99fedb1dfe98-6eba-4dc1-a11a-845fe19ddc612022-01-13WarningsExact identifier
spl id: d580ee94-9382-1177-e053-2a95a90a99fe
spl set id: db1dfe98-6eba-4dc1-a11a-845fe19ddc61

Reported adverse events (FAERS/openFDA)#

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