FDA.reportPublic FDA data

Head and Shoulders Royal Oils Frizz Tamer

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-06-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:30:12

Label at a glance#

ProductHead and Shoulders Royal Oils Frizz Tamer
Active ingredientPYRITHIONE ZINC
Label structure10 sections

Indications and uses

to help eliminate recurrence of itching, flaking, and irritation 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

to help eliminate recurrence of itching, flaking, and irritation 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, glycerin, ceresin, petrolatum, octylacrylamide/acrylates/butylaminoethyl methacrylate copolymer, copernicia cerifera (carnauba) wax, PVP, cetyl alcohol, cetearyl alcohol, ceteareth-25, mineral oil, dicaprylyl maleate, aloe barbadensis leaf juice, cannabis sativa seed oil, panthenol, niacinamide, fragrance, aminomethyl propanol, carbomer, benzyl alcohol, caprylyl glycol, 1,2-hexanediol.

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 85g jar

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ROYAL OILS

by head & shoulders ®
pyrithione zinc dandruff

treatment

FRIZZ TAMER

WITH ALOE WATER &

HEMP OIL

SMOOTHS & TAMES

EMERGING HAIR

3 OZ (85 g)

HSHS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-473-852023-06-09C16284748780-1c7ccaba7-1854-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Frizz Tamer
69423-473-852022-01-28C16284748780-1c7ccaba7-1854-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Frizz Tamer
69423-473-852021-11-14C16284748780-1c7ccaba7-1854-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Frizz Tamer
69423-473-852021-07-23C16284748780-1c7ccaba7-1854-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Frizz Tamer

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-47369423-473-85

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE K12333AG72FWJIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
GLYCERINPDC6A3C0OXIACT
MINERAL OILT5L8T28FGPIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CERESINQ1LS2UJO3AIACT
PETROLATUM4T6H12BN9UIACT
ALOE VERA LEAFZY81Z83H0XIACT
DIOCTYL MALEATEOD88G8439LIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
WATER059QF0KO0RIACT
BENZYL ALCOHOLLKG8494WBHIACT
CAPRYLYL GLYCOL00YIU5438UIACT
NIACINAMIDE25X51I8RD4IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PANTHENOLWV9CM0O67ZIACT
CETEARETH-258FA93U5T67IACT
CARNAUBA WAXR12CBM0EIZIACT
CETYL ALCOHOL936JST6JCNIACT

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
fdb6d687-ccb4-af3f-e053-6294a90a16c9ae55fab3-3176-383e-e053-2995a90a17a02023-06-09WarningsExact identifier
spl id: fdb6d687-ccb4-af3f-e053-6294a90a16c9
spl set id: ae55fab3-3176-383e-e053-2995a90a17a0

Reported adverse events (FAERS/openFDA)#

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