FDA.reportPublic FDA data

Head and Shoulders Scalp Restore

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:27:01

Label at a glance#

ProductHead and Shoulders Scalp Restore
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

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, sodium lauryl sulfate, glycol distearate, zinc carbonate, sodium chloride, fragrance, cocamidopropyl betaine, sodium xylenesulfonate, dimethicone, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, sodium laureth sulfate, menthol, mentha piperita (peppermint) flower/leaf/stem oil, mentha arvensis leaf/stem oil, melaleuca alternifolia (tea tree) leaf oil, eucalyptus globulus leaf extract, methylchloroisothiazolinone, methylisothiazolinone

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

MADE IN U.S.A. of U.S. and/or Imported Ingredients

Dist. by PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 1150 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

head &
shoulders ®

pyrithione zinc dandruff shampoo

scalp restore

SHAMPOO

WITH TEA TREE OIL &

ANTIOXIDANTS

38.8 FL OZ (1.15 L)

HSHS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043244head & shoulders 1 % Medicated ShampooPSN4
209884zinc pyrithione 1 % Medicated ShampooPSN4
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD4
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD4
1043244Head & Shoulders 1 % Medicated ShampooSY4
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY4
209884zinc pyrithione 1 % Medicated ConditionerSY4
209884zinc pyrithione 1 % Medicated ShampooSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix21049779HS.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-646-11Head and Shoulders Scalp Restore1150 mL in 1 BOTTLE, PUMPSHAMPOO11504

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-64669423-646-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
SODIUM LAURYL SULFATE368GB5141JIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDEB16G315W7AIACT
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
ZINC CARBONATEEQR32Y7H0MIACT
GLYCOL DISTEARATE13W7MDN21WIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM BENZOATEOJ245FE5EUIACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
MENTHOLL7T10EIP3AIACT
PEPPERMINTV95R5KMY2BIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
DIMETHICONE92RU3N3Y1OIACT

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 Scalp RestorePYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyecfd66a4-81f4-3463-e053-2a95a90a18b12025-12-18WarningsExact identifier
ndc (package): 69423-646-11
ndc (product): 69423-646
ndc11 (package): 69423064611
spl id: 46423141-e171-e62e-e063-6394a90a5f27
spl set id: ecfd66a4-81f4-3463-e053-2a95a90a18b1

Reported adverse events (FAERS/openFDA)#

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