FDA.reportPublic FDA data

PYRITHIONE ZINC

Manufacturer
BRANDS INTERNATIONAL
Effective date
2023-08-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:55:49

Label at a glance#

ProductPYRITHIONE ZINC
Active ingredientPYRITHIONE ZINC
Label structure10 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

For maximum dandruff control, use every time you shampoo.
Wet hair, massage unto scalp, rinse, and repeat if desired.

For best results use at least twice a week or as directed by a doctor.

WARNINGS SECTION

For external use only.

INACTIVE INGREDIENT SECTION

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Glycol Distearate, Aloe vera Leaf Extract, Parfum, Vitamin E, Methylchloroisothiazolinone,Methylisothiazolinone, FD&C Blue#1 ,FD&C Red#33.

INDICATIONS & USAGE SECTION

Helps prevent recurrence of flaking and itching associated with dandruff.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of children’s reach.

OTC - PURPOSE SECTION

Anti-dandruff

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 0.3%

OTC - STOP USE SECTION

Condition worsens or does not improve after regular use of this product as directed

OTC - WHEN USING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052932zinc pyrithione 0.3 % Medicated ShampooPSN3
1052932zinc pyrithione 3 MG/ML Medicated ShampooSCD3
1052932zinc pyrithione 0.3 % Medicated ShampooSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50157-125-102025-01-30C16284748780-12cef2736-5ba3-d83d-e063-dadaa90ab31fNext Gen Dandruff Shampoo
50157-125-352025-01-30C16284748780-12cef2736-5ba3-d83d-e063-dadaa90ab31fNext Gen Dandruff Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50157-125-10PYRITHIONE ZINC295 mL in 1 BOTTLESHAMPOO2953
50157-125-35PYRITHIONE ZINC355 mL in 1 BOTTLESHAMPOO3553

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50157-125PYRITHIONE ZINC SHAMPOO [BRANDS INTERNATIONAL]3Legacy NDC, 2 package rows20230805_e65f69d2-233f-9ebf-e053-2995a90a720e.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50157-12550157-125-10, 50157-125-35

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
SODIUM CHLORIDE451W47IQ8XIACT
GLYCOL DISTEARATE13W7MDN21WIACT
EDETATE SODIUMMP1J8420LUIACT
ALOE VERA LEAFZY81Z83H0XIACT
D&C RED NO. 339DBA0SBB0LIACT
BASIC BLUE 192N74OA24DIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
SODIUM LAURYL SULFATE368GB5141JIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB

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
021dabae-fd63-b5a6-e063-6294a90ac2aae65f69d2-233f-9ebf-e053-2995a90a720e2023-08-04WarningsExact identifier
spl id: 021dabae-fd63-b5a6-e063-6294a90ac2aa
spl set id: e65f69d2-233f-9ebf-e053-2995a90a720e

Reported adverse events (FAERS/openFDA)#

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