FDA.reportPublic FDA data

Royal Oils by Head and Shoulders Sulfate Free Scalp Care

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-01-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:51:37

Label at a glance#

ProductRoyal Oils by Head and Shoulders Sulfate Free Scalp Care
Active ingredientPYRITHIONE ZINC
Label structure10 sections

Indications and uses

helps prevent recurrence of flaking and itching associated with dandruff.

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Uses

INDICATIONS & USAGE SECTION

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens or does not improve after regular use of this product as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, lauramidopropyl betaine, sodium cocoyl isethionate, sodium lauroyl sarcosinate, sodium citrate, fragrance, sodium chloride, cocos nucifera (coconut) oil, vinegar†, acrylates copolymer, polyquaternium-10, dimethiconol, sodium benzoate, citric acid, sodium salicylate.

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 380 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ROYAL OILS

by head & shoulders ®

PYRITHIONE ZINC DANDRUFF SHAMPOO

SULFATE FREE

SCALP CARE

SHAMPOO

WITH COCONUT OIL

& APPLE CIDER VINEGAR

12.8 FL OZ (380 mL)

HSHS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043244head & shoulders 1 % Medicated ShampooPSN3
209884zinc pyrithione 1 % Medicated ShampooPSN3
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD3
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD3
1043244Head & Shoulders 1 % Medicated ShampooSY3
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY3
209884zinc pyrithione 1 % Medicated ConditionerSY3
209884zinc pyrithione 1 % Medicated ShampooSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-608-38Royal Oils by Head and Shoulders Sulfate Free Scalp Care380 mL in 1 BOTTLE, PLASTICSHAMPOO3803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-608ROYAL OILS BY HEAD AND SHOULDERS SULFATE FREE SCALP CARE (PYRITHIONE ZINC) SHAMPOO [THE PROCTER & GAMBLE MANUFACTURING COMPANY]3Current NDC, Legacy NDC, 1 package rows20250110_d73ab807-027f-7581-e053-2995a90ada83.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-60869423-608-38

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCONUT OILQ9L0O73W7LIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
DIMETHICONOL GUM4MJ9GU3T1PIACT
LAURAMIDOPROPYL BETAINE23D6XVI233IACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
SODIUM SALICYLATEWIQ1H85SYPIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM BENZOATEOJ245FE5EUIACT
APPLE CIDER VINEGAR0UE22Q87VCIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
POLYQUATERNIUM-10 (30000 MPA.S AT 2%)C7RDC8Y4JSIACT
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Royal Oils by Head and Shoulders Scalp Care Dual PackPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company1aa02661-4381-4f01-e063-6294a90aec622025-12-18WarningsExact identifier
ndc (package): 69423-608-38
ndc11 (package): 69423060838
Royal Oils by Head and Shoulders Sulfate Free Scalp CarePYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyd73ab807-027f-7581-e053-2995a90ada832025-01-08WarningsExact identifier
ndc (package): 69423-608-38
ndc (product): 69423-608
ndc11 (package): 69423060838
spl id: 2b36cce4-0a6e-779d-e063-6294a90a32f9
spl set id: d73ab807-027f-7581-e053-2995a90ada83

Reported adverse events (FAERS/openFDA)#

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