FDA.reportPublic FDA data

Head and Shoulders Molding Clay

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:18:06

Label at a glance#

ProductHead and Shoulders Molding Clay
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, cetyl alcohol, cetearyl alcohol, petrolatum, octylacrylamide/acrylates/butylaminoethyl methacrylate copolymer, copernicia cerifera (carnauba) wax, PVP, ceteareth-25,mineral oil, dicaprylyl maleate, aminomethyl propanol, carbomer, benzyl alcohol, caprylyl glycol, 1,2-hexanediol, fragrance, niacinamide, panthenol, 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 clay

MOLDING

CLAY

HIGH HOLD / MATTE FINISH

NET WT. 3 OZ (85 g)

HSHS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-418-852022-04-08C16284748780-1d6a99b39-5234-a426-e053-dadaa90af4c2Head and Shoulders ® Molding Clay
69423-418-852022-01-28C16284748780-1d6a99b39-5234-a426-e053-dadaa90af4c2Head and Shoulders ® Molding Clay

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
69423-41869423-418-85

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

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
0c91d188-b54e-86a9-e063-6394a90adeee9626f8dc-0778-a4bb-e053-2a95a90acf642023-12-15WarningsExact identifier
spl id: 0c91d188-b54e-86a9-e063-6394a90adeee
spl set id: 9626f8dc-0778-a4bb-e053-2a95a90acf64

Reported adverse events (FAERS/openFDA)#

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