FDA.reportPublic FDA data

Head and Shoulders Clinical Itch Relief Scalp Mist

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-01-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:30:06

Label at a glance#

ProductHead and Shoulders Clinical Itch Relief Scalp Mist
Active ingredientPYRITHIONE ZINC
Label structure10 sections

Dosage and administration

apply to affected areas one to four times daily or as directed by a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 0.1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Use

INDICATIONS & USAGE SECTION

for the relief of 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

  • apply to affected areas one to four times daily or as directed by a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, niacinamide, PEG-40 hydrogenated castor oil, phenoxyethanol, caffeine, bis-PEG/PPG-16/16 PEG/PPG-16/16 dimethicone, glycerin, benzyl alcohol, fragrance, menthol, acrylates/C10-30 alkyl acrylate crosspolymer, panthenol, tetrahydroxypropyl ethylenediamine, ethylhexylglycerin, mentha piperita (peppermint) oil, mentha arvensis leaf oil.

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 125 mL bottle label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

head &
shoulders ®
pyrithione zinc dandruff treatment

CLINICAL

ITCH RELIEF

SCALP MIST

SOOTHES DANDRUFF ITCH

USE BETWEEN WASHES

WITH INTENSE

COOLING MENTHOL

4.2 FL OZ (125 mL)

HSHS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-529-122024-01-30C16284748780-1c7ccaba7-156c-fd44-e053-dadaa90aa01bHead and Shoulders ® Clinical Itch Relief Scalp Mist
69423-529-122023-06-13C16284748780-1c7ccaba7-156c-fd44-e053-dadaa90aa01bHead and Shoulders ® Clinical Itch Relief Scalp Mist
69423-529-122022-01-28C16284748780-1c7ccaba7-156c-fd44-e053-dadaa90aa01bHead and Shoulders ® Clinical Itch Relief Scalp Mist
69423-529-122021-11-14C16284748780-1c7ccaba7-156c-fd44-e053-dadaa90aa01bHead and Shoulders ® Clinical Itch Relief Scalp Mist
69423-529-122021-07-23C16284748780-1c7ccaba7-156c-fd44-e053-dadaa90aa01bHead and Shoulders ® Clinical Itch Relief Scalp Mist

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-52969423-529-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
WATER059QF0KO0RIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
BENZYL ALCOHOLLKG8494WBHIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
NIACINAMIDE25X51I8RD4IACT
PANTHENOLWV9CM0O67ZIACT
CAFFEINE3G6A5W338EIACT
BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE55A74AJ3KBIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
EDETOLQ4R969U9FRIACT
PEPPERMINT OILAV092KU4JHIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT

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
1c5c2df5-5be3-e1d0-e063-6394a90acc53b6aec5b7-b278-4248-e053-2995a90aa9c92024-07-03WarningsExact identifier
spl set id: b6aec5b7-b278-4248-e053-2995a90aa9c9

Reported adverse events (FAERS/openFDA)#

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