FDA.reportPublic FDA data

Head and Shoulders Bare Minimal Ingredients Itchy Scalp Relief

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-01-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:53:52

Label at a glance#

ProductHead and Shoulders Bare Minimal Ingredients Itchy Scalp Relief
Active ingredientPYRITHIONE ZINC
Label structure10 sections

Indications and uses

fights recurrence of the symptoms of dandruff.

Dosage and administration

for best results use at least twice a week or as directed by a doctor. shake before use, wet hair, massage onto scalp, rinse, repeat if desired.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Uses

INDICATIONS & USAGE SECTION

fights recurrence of the symptoms of 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.
  • shake before use, wet hair, massage onto scalp, rinse, repeat if desired.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, lauramidopropyl betaine, sodium cocoyl isethionate, acrylates copolymer, polyquaternium-10, mentha piperita (peppermint) oil, sodium benzoate, citric acid

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 SHAMPOO

BARE

MINIMAL INGREDIENTS SHAMPOO

ITCHY SCALP RELIEF

0% SULFATES

DYES

SILICONES

13.5 FL OZ
(400 mL)

HSHS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043244head & shoulders 1 % Medicated ShampooPSN1
209884zinc pyrithione 1 % Medicated ShampooPSN1
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD1
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD1
1043244Head & Shoulders 1 % Medicated ShampooSY1
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY1
209884zinc pyrithione 1 % Medicated ConditionerSY1
209884zinc pyrithione 1 % Medicated ShampooSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-074-40Head and Shoulders Bare Minimal Ingredients Itchy Scalp Relief400 mL in 1 BOTTLE, PLASTICSHAMPOO4001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-074HEAD AND SHOULDERS BARE MINIMAL INGREDIENTS ITCHY SCALP RELIEF (PYRITHIONE ZINC) SHAMPOO [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 1 package rows20250130_2cc7724c-a1f1-a42d-e063-6394a90a83cf.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-07484126-074-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHA PIPERITA (PEPPERMINT) OILAV092KU4JHIACT
POLYQUATERNIUM-10 (30000 MPA.S AT 2%)C7RDC8Y4JSIACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID2968PHW8QPIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
WATER059QF0KO0RIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
LAURAMIDOPROPYL BETAINE23D6XVI233IACT

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 Bare Minimal Ingredients Itchy Scalp ReliefPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company2cc7724c-a1f1-a42d-e063-6394a90a83cf2025-01-28WarningsExact identifier
ndc (package): 84126-074-40
ndc (product): 84126-074
ndc11 (package): 84126007440
spl id: 2cc77222-4e92-390e-e063-6294a90a6a50
spl set id: 2cc7724c-a1f1-a42d-e063-6394a90a83cf

Reported adverse events (FAERS/openFDA)#

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