FDA.reportPublic FDA data

Head and Shoulders Supreme Detox and Hydrate

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 01:26:52

Label at a glance#

ProductHead and Shoulders Supreme Detox and Hydrate
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, argania spinosa kernel oil, zea mays (corn) silk extract, cocos nucifera (coconut) fruit extract, sodium citrate, fragrance, acrylates copolymer, polyquaternium-10, 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

DETOX &

HYDRATE

WITH ARGAN OIL

& COCONUT WATER

FREE FROM

SULFATES

PARABENS

DYES

PHOSPHATES

SILICONES

11.8 FL OZ
(350 mL)

HSHS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043244head & shoulders 1 % Medicated ShampooPSN8
209884zinc pyrithione 1 % Medicated ShampooPSN8
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD8
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD8
1043244Head & Shoulders 1 % Medicated ShampooSY8
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY8
209884zinc pyrithione 1 % Medicated ConditionerSY8
209884zinc pyrithione 1 % Medicated ShampooSY8

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
69423-343-01Head and Shoulders Supreme Detox and Hydrate2 in 1 CELLO PACKSHAMPOO28
69423-343-01Head and Shoulders Supreme Detox and Hydrate350 mL in 1 BOTTLE, PUMPSHAMPOO3508
69423-343-35Head and Shoulders Supreme Detox and Hydrate350 mL in 1 BOTTLE, PUMPSHAMPOO3508

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
69423-34369423-343-35, 69423-343-01

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
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ARGAN OIL4V59G5UW9XIACT
POLYQUATERNIUM-10 (30000 MPA.S AT 2%)C7RDC8Y4JSIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
WATER059QF0KO0RIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
COCONUT OILQ9L0O73W7LIACT
SODIUM SALICYLATEWIQ1H85SYPIACT
SODIUM CITRATE1Q73Q2JULRIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
SODIUM CHLORIDE451W47IQ8XIACT
CORN SILK7D3VB244UXIACT
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 Supreme Detox and HydratePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company8659218e-cb8d-bb44-e053-2a91aa0ae37b2025-12-18WarningsExact identifier
ndc (package): 69423-343-35
ndc (package): 69423-343-01
ndc (product): 69423-343
ndc11 (package): 69423034301
ndc11 (package): 69423034335
spl id: 46409e50-bdcf-7c1f-e063-6294a90a1602
spl set id: 8659218e-cb8d-bb44-e053-2a91aa0ae37b

Reported adverse events (FAERS/openFDA)#

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