FDA.reportPublic FDA data

Royal Oils by Head and Shoulders Scalp Care Dual Pack

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:26:44

Label at a glance#

ProductRoyal Oils by Head and Shoulders Scalp Care Dual Pack
Active ingredientPYRITHIONE ZINC
Label structure18 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

ROYAL OILS

by head & shoulders
SULFATE FREE

SCALP CARE

SHAMPOO

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.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with 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 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

ROYAL OILS

by head & shoulders
MOISTURE RENEWAL SCALP BALANCING CONDITIONER

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 0.5%

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.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with 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 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.
  • apply to wet hair after shampooing by gently massaging into hair and scalp, rinse well.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, stearyl alcohol, dimethicone, behentrimonium chloride, cetyl alcohol, cocos nucifera (coconut) fruit extract, vinegar†, zea mays (corn) silk extract, fragrance, phenoxyethanol, benzyl alcohol, citric acid, methylchloroisothiazolinone, methylisothiazolinone.

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - Kit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ROYAL OILS

by head & shoulders ®

Shampoo & Conditioner Inside

pyrithione zinc dandruff shampoo

ROYAL OILS

by head & shoulders

SULFATE FREE

SCALP CARE

SHAMPOO

ROYAL OILS

by head & shoulders

pyrithione zinc dandruff conditioner

MOISTURE RENEWAL

SCALP BALANCING

CONDITIONER

1 PYRITHIONE ZINC DANDRUFF

SHAMPOO 12.8 FL OZ (380 mL)

1 PYRITHIONE ZINC DANDRUFF

CONDITIONER 13.5 FL OZ (400 mL)

HSHS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1044465head & shoulders 0.5 % Medicated ShampooPSN3
1043244head & shoulders 1 % Medicated ShampooPSN3
1043014zinc pyrithione 0.5 % Medicated ConditionerPSN3
209884zinc pyrithione 1 % Medicated ShampooPSN3
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD3
1044465zinc pyrithione 5 MG/ML Medicated Shampoo [Head & Shoulders]SBD3
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD3
1043014zinc pyrithione 5 MG/ML Medicated ShampooSCD3
1044465Head & Shoulders 0.5 % ConditionerSY3
1043244Head & Shoulders 1 % Medicated ShampooSY3
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY3
1044465Head & Shoulders 5 MG/ML Medicated ShampooSY3
1043014zinc pyrithione 0.5 % Medicated ShampooSY3
209884zinc pyrithione 1 % Medicated ConditionerSY3
209884zinc pyrithione 1 % Medicated ShampooSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-571-40Royal Oils by Head and Shoulders Scalp Care Dual Pack400 mL in 1 BOTTLE, PLASTICLOTION400 mL0.5 g in 100mL3
69423-608-38Royal Oils by Head and Shoulders Scalp Care Dual Pack380 mL in 1 BOTTLE, PLASTICSHAMPOO380 mL1 g in 100mL3
84126-003-01Royal Oils by Head and Shoulders Scalp Care Dual Pack1 in 1 CELLO PACKKIT13

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-00384126-003-01
69423-60869423-608-38
69423-57169423-571-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
SODIUM CITRATE1Q73Q2JULRIACT
ACETIC ACIDQ40Q9N063PIACT
SODIUM SALICYLATEWIQ1H85SYPIACT
POLYQUATERNIUM-10 (30000 MPA.S AT 2%)C7RDC8Y4JSIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
WATER059QF0KO0RIACT
LAURAMIDOPROPYL BETAINE23D6XVI233IACT
SODIUM CHLORIDE451W47IQ8XIACT
DIMETHICONOL (50000 CST)R2285D73YTIACT
SODIUM BENZOATEOJ245FE5EUIACT
COCONUT OILQ9L0O73W7LIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
STEARYL ALCOHOL2KR89I4H1YIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZYL ALCOHOLLKG8494WBHIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
DIMETHICONE92RU3N3Y1OIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
COCONUT3RT3536DHYIACT
CORN SILK7D3VB244UXIACT
BEHENTRIMONIUM CHLORIDEX7GNG3S47TIACT
ACETIC ACIDQ40Q9N063PIACT

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Royal Oils by head and shoulders Moisture Renewal Scalp Balancing ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyc95e82e4-74fb-9dbf-e053-2a95a90a93e52025-12-18WarningsExact identifier
ndc (package): 69423-571-40
ndc (product): 69423-571
ndc11 (package): 69423057140
Royal Oils by Head and Shoulders Scalp Care Dual PackPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company1aa02661-4381-4f01-e063-6294a90aec622025-12-18WarningsExact identifier
ndc (package): 84126-003-01
ndc (package): 69423-608-38
ndc (package): 69423-571-40
ndc (product): 84126-003
ndc11 (package): 84126000301
ndc11 (package): 69423057140
ndc11 (package): 69423060838
spl id: 4642951a-e287-a8c2-e063-6294a90a61ec
spl set id: 1aa02661-4381-4f01-e063-6294a90aec62
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

Reported adverse events (FAERS/openFDA)#

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