FDA.reportPublic FDA data

Head and Shoulders Clinical Scalp Calming Treatment

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:18:10

Label at a glance#

ProductHead and Shoulders Clinical Scalp Calming Treatment
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 .2%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Uses

INDICATIONS & USAGE SECTION

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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, glutamic acid, benzyl alcohol, phenoxyethanol, methylparaben, dimethicone, propylparaben, fragrance, citric acid, aloe barbadensis leaf juice.

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 Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

head &
shoulders ®

PYRITHIONE ZINC DANDRUFF

TREATMENT

CLINICAL SCALP CALMING

TREATMENT

RELIEVES IRRITATION ON A SENSITIVE SCALP*

USE BETWEEN WASHES INFUSED WITH ALOE VERA

3.3 FL OZ (100 mL)

HSHS

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
69423-64169423-641-10

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
PROPYLPARABENZ8IX2SC1OHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYLPARABENA2I8C7HI9TIACT
DIMETHICONE92RU3N3Y1OIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
STEARAMIDOPROPYL DIMETHYLAMINEK7VEI00UFRIACT
GLUTAMIC ACID3KX376GY7LIACT
BENZYL ALCOHOLLKG8494WBHIACT
STEARYL ALCOHOL2KR89I4H1YIACT
ALOE VERA LEAFZY81Z83H0XIACT

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
0c92579b-5d4b-ac10-e063-6394a90aa854ec0987dd-6fad-6482-e053-2995a90a2dd12023-12-15WarningsExact identifier
spl id: 0c92579b-5d4b-ac10-e063-6394a90aa854
spl set id: ec0987dd-6fad-6482-e053-2995a90a2dd1

Reported adverse events (FAERS/openFDA)#

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