FDA.reportPublic FDA data

Pyrithione zinc

Manufacturer
Old East Main Co. | Nice-Pak Products, LLC
Effective date
2026-03-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:48:29

Label at a glance#

ProductPyrithione zinc
Active ingredientPYRITHIONE ZINC
Label structure13 sections

Dosage and administration

shake well for maximum dandruff controll, 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

Multiple Benefit formula to help:

  • Fight dry scalp
  • Calm itch
  • Relieve irritation
  • Soothe and reduce redness
  • Reduce oiliness
  • Prevent flakes
  • Leave hair healthy looking

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 controll, 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

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Head & Shoulders ® Tea Tree Oil 2in1 Dandruff Shampoo + Conditioner.

Adverse Reactions

ADVERSE REACTIONS SECTION

100% Satisfaction Guaranteed!

(888)309-9030

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STUDIO

SELECTION ®

TEA TREE

DANDRUFF SHAMPOO + CONDITIONER

PYRITHIONE ZINC 1%

Compare to Head & Shoulders ® Tea Tree Oil 2 in 1 Dandruff Shampoo & Conditioner*

  • Cooling relief from scalp itch
  • Paraben free

2in1

Paraben + Phthalate Free

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75712-470-32Pyrithione 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
75712-47075712-470-32

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 ZINCOld East Main Co.f17154e2-1bcf-43f9-b201-e84d374a05912026-03-02Warnings, Adverse reactionsExact identifier
ndc (package): 75712-470-32
ndc (product): 75712-470
ndc11 (package): 75712047032
spl id: 4c0fa07b-b80f-095d-e063-6394a90a8d88
spl set id: f17154e2-1bcf-43f9-b201-e84d374a0591

Reported adverse events (FAERS/openFDA)#

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