FDA.reportPublic FDA data

Head and Shoulders Royal Oils Nighttime Scalp Tonic

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2020-12-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:01:23

Label at a glance#

ProductHead and Shoulders Royal Oils Nighttime Scalp Tonic
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. • squeeze product directly onto exposed scalp & massage in slowly. Do not rinse.

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.

• squeeze product directly onto exposed scalp & massage in slowly. Do not rinse.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, mentha piperita (peppermint) leaf extract, mentha arvensis leaf oil, menthol, cannabis sativa seed oil, dimethicone, cetyl alcohol, stearyl alcohol, stearamidopropyl dimethylamine, cetearyl alcohol, quaternium-18, fragrance, hydroxyethylcellulose, PEG-2M, glyceryl stearate, oleyl alcohol, polysorbate 60, phenoxyethanol, citric acid, benzyl alcohol, propylparaben, methylparaben.

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 100 mL bottle label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ROYAL OILS

by Head & Shoulders

PYRITHIONE ZINC DANDRUFF TREATMENT

NIGHTTIME SCALP

TONIC LOTION

WITH PEPPERMINT &

HEMP OIL

NOURISHES SCALP &

SOOTHES ITCH*

3.38 FL OZ (100 mL)

HSHS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-474-102023-06-09C16284748780-1d6a99b39-9a75-a426-e053-dadaa90af4c2Head and Shoulders ® Royal Oils Nighttime Scalp Tonic
69423-474-102022-01-28C16284748780-1d6a99b39-9a75-a426-e053-dadaa90af4c2Head and Shoulders ® Royal Oils Nighttime Scalp Tonic

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-47469423-474-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARAMIDOPROPYL DIMETHYLAMINEK7VEI00UFRIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
POLYSORBATE 60CAL22UVI4MIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLPARABENA2I8C7HI9TIACT
POLYETHYLENE OXIDE 100000V46Y6OJ5QBIACT
OLEYL ALCOHOL172F2WN8DVIACT
PROPYLPARABENZ8IX2SC1OHIACT
QUATERNIUM-18O7757NO1VLIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CETYL ALCOHOL936JST6JCNIACT
WATER059QF0KO0RIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZYL ALCOHOLLKG8494WBHIACT
MENTHA PIPERITA LEAFA389O33LX6IACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
DIMETHICONE92RU3N3Y1OIACT

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
fdb70fe0-c9fa-8628-e053-6394a90a328eb6ac1965-c724-e474-e053-2a95a90a6e472023-06-09WarningsExact identifier
spl set id: b6ac1965-c724-e474-e053-2a95a90a6e47

Reported adverse events (FAERS/openFDA)#

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