FDA.reportPublic FDA data

Head and Shoulders Supreme Soothe and Strengthen

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:26:52

Label at a glance#

ProductHead and Shoulders Supreme Soothe and Strengthen
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. for maximum dandruff control, use every time you shampoo. 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

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.
  • for maximum dandruff control, use every time you shampoo.
  • shake before use.
  • wet hair, massage onto scalp, rinse, repeat if desired.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, lauramidopropyl betaine, sodium cocoyl isethionate, sodium lauroyl sarcosinate, sodium chloride, rosa gallica flower extract, argania spinosa kernel oil, sodium citrate, acrylates copolymer, polyquaternium-10, fragrance, dimethiconol, citric acid, sodium benzoate, sodium salicylate.

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 350 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

head &
shoulders ®
PYRITHIONE ZINC DANDRUFF

SCALP & HAIR SHAMPOO

SUPREME

SOOTHE &

STRENGTHEN

WITH ARGAN OIL

& ROSE ESSENCE

FREE FROM

SULFATES

DYES

PARABENS

PHOSPHATES

PHTHALATES

11.8 FL OZ
(350 mL)

HSHS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043244head & shoulders 1 % Medicated ShampooPSN6
209884zinc pyrithione 1 % Medicated ShampooPSN6
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD6
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD6
1043244Head & Shoulders 1 % Medicated ShampooSY6
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY6
209884zinc pyrithione 1 % Medicated ConditionerSY6
209884zinc pyrithione 1 % Medicated ShampooSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-345-35Head and Shoulders Supreme Soothe and Strengthen350 mL in 1 BOTTLE, PUMPSHAMPOO3506
69423-345-83Head and Shoulders Supreme Soothe and Strengthen835 mL in 1 BOTTLE, PUMPSHAMPOO8356

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-34569423-345-35, 69423-345-83

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM SALICYLATEWIQ1H85SYPIACT
ARGAN OIL4V59G5UW9XIACT
POLYQUATERNIUM-10 (30000 MPA.S AT 2%)C7RDC8Y4JSIACT
ROSA GALLICA FLOWERX8W61WUV70IACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
WATER059QF0KO0RIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
SODIUM CHLORIDE451W47IQ8XIACT
LAURAMIDOPROPYL BETAINE23D6XVI233IACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
SODIUM CITRATE1Q73Q2JULRIACT
DIMETHICONOL GUM4MJ9GU3T1PIACT

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 Supreme Soothe and StrengthenPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company86972263-dcef-358f-e053-2991aa0a734f2025-12-18WarningsExact identifier
ndc (package): 69423-345-35
ndc (package): 69423-345-83
ndc (product): 69423-345
ndc11 (package): 69423034535
ndc11 (package): 69423034583
spl id: 4640ae81-0efa-0677-e063-6394a90a5a89
spl set id: 86972263-dcef-358f-e053-2991aa0a734f

Reported adverse events (FAERS/openFDA)#

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