FDA.reportPublic FDA data

Head and Shoulders Root Rejuvenating Pre-Wash Mask

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2020-02-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:41:54

Label at a glance#

ProductHead and Shoulders Root Rejuvenating 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. gentlly 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

OTC - DO NOT USE SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, sodium laureth sulfate, cocamide MEA, sodium xylenesulfonate, zinc carbonate, glycol distearate, sodium lauryl sulfate, cocamidopropyl betaine, fragrance, sodium chloride, dimethicone, menthol, guar hydroxypropyltrimoniumchloride, sodium benzoate, stearyl alcohol, magnesium carbonate hydroxide, cetyl alcohol, polyquaternium-76,mentha piperita (peppermint) oil, mentha arvensis leaf oil, melaleuca alternifolia (tea tree) leaf oil, methylchloroisothiazolinone,methylisothiazolinone, yellow 5, blue 1.

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 Pouch/sachet Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

head &

shoulders ®

pyrithione zinc
dandruff treatment

ROOT

REJUVENATING

PRE-WASH MASK

with tea tree extract

1.5 FL OZ

(50 mL) HSHS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-303-502020-02-04C16284748780-19d75b9d1-1476-f424-e053-dadaa90a57ceHead and Shoulders ® Root Rejuvenating Pre-Wash Mask Men Old Spice ® Pure Sport
69423-303-502020-01-31C16284748780-19d75b9d1-1476-f424-e053-dadaa90a57ceHead and Shoulders ® Root Rejuvenating Pre-Wash Mask Men Old Spice ® Pure Sport

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-30369423-303-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
PEPPERMINT OILAV092KU4JHIACT
GLYCOL DISTEARATE13W7MDN21WIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
COCO MONOETHANOLAMIDEC80684146DIACT
CETYL ALCOHOL936JST6JCNIACT
TEA TREE OILVIF565UC2GIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
ZINC CARBONATEEQR32Y7H0MIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
DIMETHICONE92RU3N3Y1OIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM BENZOATEOJ245FE5EUIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
STEARYL ALCOHOL2KR89I4H1YIACT

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
9dc82434-4326-1853-e053-2995a90a04147aa684df-c0b1-2dbc-e053-2991aa0a665f2020-02-04WarningsExact identifier
spl id: 9dc82434-4326-1853-e053-2995a90a0414
spl set id: 7aa684df-c0b1-2dbc-e053-2991aa0a665f

Reported adverse events (FAERS/openFDA)#

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