FDA.reportPublic FDA data

Head and Shoulders Grooming

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2020-07-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:23:24

Label at a glance#

ProductHead and Shoulders Grooming
Active ingredientPYRITHIONE ZINC
Label structure10 sections

Indications and uses

Use to help eliminate recurrence of itching, flaking, and irritation associated with dandruff.

Dosage and administration

apply to affected areas one to four times daily or as directed by doctor apply a small amount of product in hands and work through damp or dry hair from root to tip and style as 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

Use to help eliminate recurrence of itching, flaking, and irritation 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

  • apply to affected areas one to four times daily or as directed by doctor
  • apply a small amount of product in hands and work through damp or dry hair from root to tip and style as desired.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, ceresin, cetearyl alcohol, petrolatum, cetyl alcohol, copernicia cerifera (carnauba) wax, octylacrylamide/acrylates/butylaminoethyl methacrylate copolymer, ceteareth-25, PVP, dicaprylyl maleate, mineral oil, aminomethyl propanol, carbomer, benzyl alcohol, 1,2-hexanediol, caprylyl glycol, fragrance, panthenol, niacinamide, caramel.

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 85 g Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

head &

shoulders ®

pyrithione zinc dandruff paste

GROOMING

PASTE

MEDIUM HOLD / MATTE FINISH

NET WT. 3 OZ (85 g)

HSHS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2104630Head & Shoulders 0.1 % Topical CreamPSN1
247812zinc pyrithione 0.1 % Topical CreamPSN1
2104630zinc pyrithione 1 MG/ML Topical Cream [Head & Shoulders]SBD1
247812zinc pyrithione 1 MG/ML Topical CreamSCD1
2104630Head & Shoulders 0.1 % Topical CreamSY1
2104630Head & Shoulders 1 MG/ML Topical CreamSY1
247812zinc pyrithione 0.1 % Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-480-852022-01-28C16284748780-1d6a99b39-5cfb-a426-e053-dadaa90af4c2Head and Shoulders ® Grooming Paste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-480-85Head and Shoulders Grooming85 g in 1 JARPASTE851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-480HEAD AND SHOULDERS GROOMING (PYRITHIONE ZINC) PASTE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Legacy NDC, 1 package rows20200801_aaf7c53d-251d-a0f4-e053-2995a90a0e04.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-48069423-480-85

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
NIACINAMIDE25X51I8RD4IACT
CARNAUBA WAXR12CBM0EIZIACT
CAPRYLYL GLYCOL00YIU5438UIACT
MINERAL OILT5L8T28FGPIACT
DIOCTYL MALEATEOD88G8439LIACT
BENZYL ALCOHOLLKG8494WBHIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PANTHENOLWV9CM0O67ZIACT
CETEARETH-258FA93U5T67IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
POVIDONE K12333AG72FWJIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PETROLATUM4T6H12BN9UIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CARAMELT9D99G2B1RIACT
CERESINQ1LS2UJO3AIACT
CETYL ALCOHOL936JST6JCNIACT
WATER059QF0KO0RIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB

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
aaf7e538-b949-4de9-e053-2a95a90a87ffaaf7c53d-251d-a0f4-e053-2995a90a0e042020-07-21WarningsExact identifier
spl id: aaf7e538-b949-4de9-e053-2a95a90a87ff
spl set id: aaf7c53d-251d-a0f4-e053-2995a90a0e04

Reported adverse events (FAERS/openFDA)#

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