FDA.reportPublic FDA data

Dandruff

Manufacturer
Retail Business Services, LLC | Nice-Pak Products, LLC
Effective date
2026-02-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:37:21

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
  • Calm Itch
  • Relieve irritation
  • Soothe and reduce redness
  • Reduce oiliness
  • Prevents 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 or 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, the owner of the registered trademark Head & Shoulders 2 in 1 Classic Clean Dandruff Shampoo + Conditioner.

Adverse reactions

ADVERSE REACTIONS SECTION

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions or concerns, contact us at 1-833-992-3872

Quality guaranteed or your money back.

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAREone ®

Compare to Head & Shoulders ®Classic Clean Dandruff Shampoo + Conditioner*

2 IN 1

EVERYDAY CLEAN

DANDRUFF SHAMPOO & CONDITIONER

Dandruff Fighting Formula

  • Moisturizes to help relieve dry scalp
  • Pyrithione Zinc

20.7 FL OZ (1.29 PT) 612 mL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN5
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD5
209884zinc pyrithione 1 % Medicated ConditionerSY5
209884zinc pyrithione 1 % Medicated ShampooSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-311-15Dandruff420 mL in 1 BOTTLE, PLASTICSHAMPOO4205
72476-311-32Dandruff370 mL in 1 BOTTLE, PLASTICSHAMPOO3705
72476-311-35Dandruff700 mL in 1 BOTTLE, PLASTICSHAMPOO7005
72476-311-40Dandruff612 mL in 1 BOTTLE, PLASTICSHAMPOO6125
72476-311-86Dandruff1000 mL in 1 BOTTLE, PLASTICSHAMPOO10005

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
72476-31172476-311-32, 72476-311-15, 72476-311-40, 72476-311-35, 72476-311-86

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 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
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42026-01-13monthly-update2026-06-03 17:52:42

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 ZINCRetail Business Services, LLCc8c82495-f09a-4ec1-9036-e464845e02f92026-02-06Warnings, Adverse reactionsExact identifier
ndc (package): 72476-311-86
ndc (package): 72476-311-15
ndc (package): 72476-311-32
ndc (package): 72476-311-35
ndc (package): 72476-311-40
ndc (product): 72476-311
ndc11 (package): 72476031186
ndc11 (package): 72476031135
ndc11 (package): 72476031140
ndc11 (package): 72476031115
ndc11 (package): 72476031132
spl id: 4a2b79c2-3d48-4fe7-e063-6394a90a3acb
spl set id: c8c82495-f09a-4ec1-9036-e464845e02f9

Reported adverse events (FAERS/openFDA)#

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