FDA.reportPublic FDA data

Head and Shoulders Royal Oils Seal and Prep Moisture Milk

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-01-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:40:37

Label at a glance#

ProductHead and Shoulders Royal Oils Seal and Prep Moisture Milk
Active ingredientPYRITHIONE ZINC
Label structure10 sections

Indications and uses

helps prevent recurrence of flaking and itching associated with dandruff.

Dosage and administration

• apply to affected areas one to four times daily or as directed by a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 0.1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Uses

INDICATIONS & USAGE SECTION

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED 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

• apply to affected areas one to four times daily or as directed by a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, stearyl alcohol, cetyl alcohol, stearamidopropyl dimethylamine, cocos nucifera (coconut) oil, dimethicone, glutamic acid, fragrance, phenoxyethanol, benzyl alcohol, methylparaben, propylparaben, citric acid.

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 193 mL Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

head &
shoulders ®
pyrithione zinc dandruff treatment

ROYAL OILS

SEAL & PREP

MOISTURE MILK

WITH COCONUT OIL

LOCKS IN FLAKE PROTECTION*

& PREPS HAIR FOR STYLING

SULFATE & DYE FREE

6.5 FL OZ
(193 mL)

HSHS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-409-192021-11-14C16284748780-1c7ccaba7-20a9-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Seal & Prep Moisture Milk
69423-409-192021-07-23C16284748780-1c7ccaba7-20a9-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Seal & Prep Moisture Milk

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-40969423-409-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL ALCOHOL936JST6JCNIACT
STEARAMIDOPROPYL DIMETHYLAMINEK7VEI00UFRIACT
COCONUT OILQ9L0O73W7LIACT
METHYLPARABENA2I8C7HI9TIACT
GLUTAMIC ACID3KX376GY7LIACT
DIMETHICONE92RU3N3Y1OIACT
PROPYLPARABENZ8IX2SC1OHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARYL ALCOHOL2KR89I4H1YIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
BENZYL ALCOHOLLKG8494WBHIACT

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
f216ad85-ecbf-3d70-e053-2a95a90ad77295fea758-7cf4-7304-e053-2a95a90aa2d32023-01-12WarningsExact identifier
spl id: f216ad85-ecbf-3d70-e053-2a95a90ad772
spl set id: 95fea758-7cf4-7304-e053-2a95a90aa2d3

Reported adverse events (FAERS/openFDA)#

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