FDA.reportPublic FDA data

Zolidyne

Manufacturer
Topiderm, Inc. | Topix Pharmaceuticals, Inc.
Effective date
2019-11-20
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:59:33

Label at a glance#

ProductZolidyne
Active ingredientPYRITHIONE ZINC
Label structure8 sections

Indications and uses

A gentle, specially formulated shampoo for the control of flaking and itching associated with dandruff or seborrheic dermatitis.

Dosage and administration

Massage into wet scalp, lather well and rinse, leaving lather on scalp for 3-5 minutes For best results, use at least twice a week or as directed by your doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Pyrithione, 2%

Purpose

OTC - PURPOSE SECTION

Antidandruff, Seborrheic Dermatitis

Uses

INDICATIONS & USAGE SECTION

  • A gentle, specially formulated shampoo for the control of flaking and itching associated with dandruff or seborrheic dermatitis.

Warnings

WARNINGS SECTION

For external use only

  • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
  • If condition worsens or does not improve after regular use of this product as directed, consult a doctor
  • If condition covers a large area of the body, consult your doctor before using this product

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Massage into wet scalp, lather well and rinse, leaving lather on scalp for 3-5 minutes

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ammonium Lauryl Sulfate, Citric Acid, Cocamidopropyl Betaine, Ethylene Glycol Distearate, FD&C Blue #1, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Lauramide MIPA, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Laureth Sulfate, Water.

PRINCIPAL DISPLAY PANEL - 200 ml Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DERMA
TOPIX

zolidyne
shampoo

Zinc Pyrithione, 2%

Net 6.7 fl. oz. (200 ml.)

Topix Pharmaceuticals, Inc.
N. Amityville, NY 11701

PRINCIPAL DISPLAY PANEL - 200 ml Tube Label
PRINCIPAL DISPLAY PANEL - 200 ml Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244458zinc pyrithione 2 % Medicated ShampooPSN7
244458zinc pyrithione 20 MG/ML Medicated ShampooSCD7
244458zinc pyrithione 2 % Medicated ShampooSY7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51326-203-67Zolidyne200 mL in 1 TUBESHAMPOO2007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51326-203ZOLIDYNE (PYRITHIONE ZINC) SHAMPOO [TOPIDERM, INC.]7Current NDC, Legacy NDC, 1 package rows20231109_6d5eaecc-a3a1-4739-ae5b-66df4a15cd21.zip

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
51326-20351326-203-67

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
PYRITHIONE ZINCR953O2RHZ5ACTIB
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCOL DISTEARATE13W7MDN21WIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GLYCERINPDC6A3C0OXIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LAURIC ISOPROPANOLAMIDE82DUX3RRVUIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
WATER059QF0KO0RIACT

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
ZolidynePYRITHIONE ZINCTopiderm, Inc.6d5eaecc-a3a1-4739-ae5b-66df4a15cd212019-11-20WarningsExact identifier
ndc (package): 51326-203-67
ndc (product): 51326-203
ndc11 (package): 51326020367
spl id: 34c76824-3047-41a6-805a-a17e63e0c019
spl set id: 6d5eaecc-a3a1-4739-ae5b-66df4a15cd21

Reported adverse events (FAERS/openFDA)#

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