FDA.reportPublic FDA data

Head and Shoulders Scalp Detoxifying Pre-Wash Mask

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2020-02-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:41:53

Label at a glance#

ProductHead and Shoulders Scalp Detoxifying Pre-Wash Mask
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. gently shake before use wet hair and massage onto scalp, focusing on the roots. rinse well.

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.
  • gently shake before use
  • wet hair and massage onto scalp, focusing on the roots.
  • rinse well.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, zinc carbonate, sodium chloride, sodium xylenesulfonate, fragrance, cocamidopropyl betaine, dimethicone, menthol, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, mentha piperita (peppermint) oil, mentha arvensis leaf oil, eucalyptus globulus leaf extract, methylchloroisothiazolinone, methylisothiazolinone.

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 50 mL Sachet/ Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

head &
shoulders ®
pyrithione zinc dandruff treatment

SCALP

DETOXIFYING

PRE-WASH MASK

WITH A EUCALYPTUS + MINT BLEND

DEEPLY CLEANS AND LIFTS AWAY IMPURITIES TO

REFRESH AND RE-START YOUR SCALP

1.7 FL OZ
(50 mL)

HSHS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-302-502020-02-04C16284748780-19d75b9d0-64f0-f424-e053-dadaa90a57ceHead and Shoulders ® Scalp Detoxifying Pre-Wash Mask
69423-302-502020-01-31C16284748780-19d75b9d0-64f0-f424-e053-dadaa90a57ceHead and Shoulders ® Scalp Detoxifying Pre-Wash Mask

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-30269423-302-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM XYLENESULFONATEG4LZF950URIACT
ZINC CARBONATEEQR32Y7H0MIACT
SODIUM CHLORIDE451W47IQ8XIACT
PEPPERMINT OILAV092KU4JHIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
GLYCOL DISTEARATE13W7MDN21WIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM LAURYL SULFATE368GB5141JIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
MENTHOLL7T10EIP3AIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
SODIUM BENZOATEOJ245FE5EUIACT

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
9dc8097e-e271-3747-e053-2995a90af3c57aa5ead3-5b77-5fa5-e053-2991aa0a575c2020-02-04WarningsExact identifier
spl id: 9dc8097e-e271-3747-e053-2995a90af3c5
spl set id: 7aa5ead3-5b77-5fa5-e053-2991aa0a575c

Reported adverse events (FAERS/openFDA)#

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