FDA.reportPublic FDA data

Head and Shoulders Itchy Scalp Care

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2019-06-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:19:58

Label at a glance#

ProductHead and Shoulders Itchy Scalp Care Hair and Scalp Conditioner
Active ingredientPYRITHIONE ZINC
Label structure10 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. apply to wet hair after shampooing by gently massaging into hair and scalp, rinse well.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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

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

  • 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, cetyl alcohol, stearamidopropyl dimethylamine, fragrance, glutamic acid, dimethicone, phenoxyethanol, benzyl alcohol, citric acid, sodium chloride, mentha piperita (peppermint) oil, menthol, mentha arvensis leaf oil, eucalyptus globulus leaf extract, 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 - 400 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

head &
shoulders ®
pyrithione zinc dandruff conditioner

itchy scalp care

HAIR & SCALP

CONDITIONER

relieves scalp itch*

with eucalyptus

13.5 FL OZ
(400 mL)

HS1HS1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-16169423-161-40

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
WATER059QF0KO0RIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CETYL ALCOHOL936JST6JCNIACT
STEARAMIDOPROPYL DIMETHYLAMINEK7VEI00UFRIACT
GLUTAMIC ACID3KX376GY7LIACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZYL ALCOHOLLKG8494WBHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CHLORIDE451W47IQ8XIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
PEPPERMINT OILAV092KU4JHIACT
MENTHOLL7T10EIP3AIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT

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
8c4efdfd-6d83-7143-e053-2995a90afdff426397fa-82ef-382b-e054-00144ff8d46c2019-06-27WarningsExact identifier
spl id: 8c4efdfd-6d83-7143-e053-2995a90afdff
spl set id: 426397fa-82ef-382b-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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