FDA.reportPublic FDA data

Dandruff

Manufacturer
Nice-Pak Products, LLC
Effective date
2026-03-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:49:58

Label at a glance#

ProductDandruff
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

Multiple benefit formula to help:

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

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, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders ® Classic Clean Dandruff Shampoo.

Adverse Reaction

ADVERSE REACTIONS SECTION

Distributed by: Consumer Product Partners, LLC

St. Louis, MO 63114

1-888-593-0593

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SIMPLY U ®

DANDRUFF

SHAMPOO

PYRITHIONE ZINC

EVERYDAY CLEAN

  • Helps relieve scalp dryness, itch and irritaion
  • Gentle and pH balanced for everyday use

Compare to Head & Shoulders ® Classic Clean Dandruff Shampoo*

12.5 FL OZ (370 mL)

mm01mm01mm02mm02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN2
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD2
209884zinc pyrithione 1 % Medicated ConditionerSY2
209884zinc pyrithione 1 % Medicated ShampooSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11344-153-32Dandruff370 mL in 1 BOTTLE, PLASTICSHAMPOO3702

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
11344-15311344-153-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
ZINC CARBONATEEQR32Y7H0MIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GLYCOL DISTEARATE13W7MDN21WIACT
D&C RED NO. 339DBA0SBB0LIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
AMODIMETHICONE (800 CST)363Z2T48P7IACT
SODIUM BENZOATEOJ245FE5EUIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
SODIUM LAURYL SULFATE368GB5141JIACT

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
DandruffPYRITHIONE ZINCNice-Pak Products, LLC3c55b70f-7627-8667-e063-6394a90a5cf82026-03-12Warnings, Adverse reactionsExact identifier
ndc (package): 11344-153-32
ndc (product): 11344-153
ndc11 (package): 11344015332
spl id: 4cd63c29-0bf3-9973-e063-6294a90af2fb
spl set id: 3c55b70f-7627-8667-e063-6394a90a5cf8

Reported adverse events (FAERS/openFDA)#

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