FDA.reportPublic FDA data

Pyrithione zinc

Manufacturer
Topco Associates LLC | Nice-Pak Products, LLC
Effective date
2026-02-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:44:07

Label at a glance#

ProductPyrithione zinc
Active ingredientPYRITHIONE ZINC
Label structure13 sections

Dosage and administration

shake well for maximum dandruff control, use every time you shampoo wet hair, massage onto scalp, rinse, repeat if desired for best results use at least twice a week or as directed by a doctor

Label contents#

Full prescribing information#

claims

SPL UNCLASSIFIED SECTION

QUALITY GUARANTEED

This TopCare ®product is laboratory tested to guarantee its highest quality.

Your total satisfaction is guaranteed.

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Use

INDICATIONS & USAGE SECTION

helps prevent recurrence of flaking and itching associated with dandruff

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes.  If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep 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

  • shake well
  • for maximum dandruff control, use every time you shampoo
  • wet hair, massage onto scalp, rinse, repeat if desired
  • for best results use at least twice a week or as directed by a doctor

inactive ingredients

INACTIVE INGREDIENT SECTION

water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, Mentha piperita (peppermint) oil, Mentha arvensis leaf oil, Melaleuca alternifolia (tea tree) leaf oil, citric acid, methylchloroisothiazolinone, methylisothiazolinone, hydroxycitronellal, linalool, blue 1, yellow 5

Adverse Reactions

ADVERSE REACTIONS SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143 ©TOPCO VIJA0624

QUESTIONS? 1-888-423-0139

topcare@topco.com www.topcarebrand.com

Scan here for more information or call 1-888-423-0139

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders ®Dandruff 2-in-1 Shampoo & Conditioner Tea Tree Oil.

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to HEAD & SHOULDERS ®Dandruff 2-in-1 Shampoo & Conditioner Tea Tree Oil*

Top Care ®

beauty

2-in-1

Dandruff Shampoo + Conditioner

with Pyrithione Zinc

With tea tree oil

Cooling relief

Gentle and pH balanced for everyday use

12.5 FL OZ (370 mL)

image descriptionimage descriptionimage descriptionimage description

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130036800015456GTIN-13: 0036800015456
EAN-13: 0036800015456
GTIN-12: 036800015456
UPC-A: 036800015456
GTIN storage (14 digits): 00036800015456		mm02.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-970-32Pyrithione zinc370 mL in 1 BOTTLE, PLASTICSHAMPOO3704

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-97076162-970-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
GLYCOL DISTEARATE13W7MDN21WIACT
SODIUM CHLORIDE451W47IQ8XIACT
ZINC CARBONATEEQR32Y7H0MIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
AMODIMETHICONE (800 CST)363Z2T48P7IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM BENZOATEOJ245FE5EUIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
PEPPERMINT OILAV092KU4JHIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
TEA TREE OILVIF565UC2GIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
HYDROXYCITRONELLAL8SQ0VA4YURIACT
LINALOOL, (+/-)-D81QY6I88EIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
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
Pyrithione zincPYRITHIONE ZINCTopco Associates LLC2c1420a8-404f-4fd7-8f07-cd441b390ac22026-02-13Warnings, Adverse reactionsExact identifier
ndc (package): 76162-970-32
ndc (product): 76162-970
ndc11 (package): 76162097032
spl id: 4ab95f11-c8a5-04b5-e063-6294a90a79d9
spl set id: 2c1420a8-404f-4fd7-8f07-cd441b390ac2

Reported adverse events (FAERS/openFDA)#

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