FDA.reportPublic FDA data

Head and Shoulders Royal Oils Instant Soothe Scalp

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:26:51

Label at a glance#

ProductHead and Shoulders Royal Oils Instant Soothe Scalp
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. • section hair if needed. Remove cap and place nozzle directly onto the scalp. • pump to cover entire section of exposed scalp (may take 3 or more pumps.) Massage into scalp. • repeat to cover entire scalp. 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.

• section hair if needed. Remove cap and place nozzle directly

onto the scalp.

• pump to cover entire section of exposed scalp (may take 3 or

more pumps.) Massage into scalp.

• repeat to cover entire scalp. Do not rinse.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, niacinamide, PEG-40 hydrogenated castor oil, menthol, mentha piperita (peppermint) oil, mentha arvensis leaf oil, phenoxyethanol, caffeine, bis-PEG/PPG-16/16 PEG/PPG-16/16 dimethicone, glycerin, fragrance, benzyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, panthenol, tetrahydroxypropyl ethylenediamine, ethylhexylglycerin.

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 125 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

head &
shoulders ®
pyrithione zinc dandruff treatment

ROYAL OILS

INSTANT SOOTHE

SCALP ELIXIR

with COOLING MENTHOL

& PEPPERMINT OIL

RELIEVES ITCHY*, DRY SCALP

ALL DAY, NO-RINSE

SCALP PROTECTION*

SULFATE, PARABEN &

DYE FREE

4.2 FL OZ
(125 mL)

HSHS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2104634Head & Shoulders 0.1 % Topical LotionPSN8
1052676pyrithione zinc 0.1 % Topical LotionPSN8
2104634zinc pyrithione 1 MG/ML Topical Lotion [Head & Shoulders]SBD8
1052676zinc pyrithione 1 MG/ML Topical LotionSCD8
2104634Head & Shoulders 0.1 % Topical LotionSY8
2104634Head & Shoulders 1 MG/ML Topical LotionSY8
1052676zinc pyrithione 0.1 % Topical LotionSY8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-309-122024-01-30C16284748780-1c7ccaba7-1bd5-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-502024-01-30C16284748780-1c7ccaba7-1bd5-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-122022-11-17C16284748780-1c7ccaba7-1bd5-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-502022-11-17C16284748780-1c7ccaba7-1bd5-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-122022-01-28C16284748780-1c7ccaba7-1bd5-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-502022-01-28C16284748780-1c7ccaba7-1bd5-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-122021-11-14C16284748780-1c7ccaba7-1bd5-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-502021-11-14C16284748780-1c7ccaba7-1bd5-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-122021-07-23C16284748780-1c7ccaba7-1bd5-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-502021-07-23C16284748780-1c7ccaba7-1bd5-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Instant Soothe Scalp Elixir

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-309-12Head and Shoulders Royal Oils Instant Soothe Scalp125 mL in 1 BOTTLE, PUMPLOTION1258
69423-309-12Head and Shoulders Royal Oils Instant Soothe Scalp1 in 1 CARTONLOTION18
69423-309-50Head and Shoulders Royal Oils Instant Soothe Scalp50 mL in 1 BOTTLE, PUMPLOTION508

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-30969423-309-12, 69423-309-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
NIACINAMIDE25X51I8RD4IACT
WATER059QF0KO0RIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZYL ALCOHOLLKG8494WBHIACT
PEPPERMINT OILAV092KU4JHIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
CAFFEINE3G6A5W338EIACT
BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE55A74AJ3KBIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
COCONUT OILQ9L0O73W7LIACT
PANTHENOLWV9CM0O67ZIACT
EDETOLQ4R969U9FRIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
Head and Shoulders Royal Oils Instant Soothe ScalpPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a2025-12-18WarningsExact identifier
ndc (package): 69423-309-50
ndc (package): 69423-309-12
ndc (product): 69423-309
ndc11 (package): 69423030950
ndc11 (package): 69423030912
spl id: 464059e8-1f3b-f3ba-e063-6294a90a2dab
spl set id: 7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a

Reported adverse events (FAERS/openFDA)#

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