FDA.reportPublic FDA data

Head and Shoulders Clinical Solutions Leave-On Dandruff Treatment

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2020-01-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:42:26

Label at a glance#

ProductHead and Shoulders Clinical Solutions Leave-On Dandruff Treatment
Active ingredientPYRITHIONE ZINC
Label structure10 sections

Dosage and administration

entire scalp. apply to affected areas one to four times daily or as directed by a doctor. place package tip close to scalp on damp or dry hair and use 15 sprays to cover the

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

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

WARNINGS SECTION

FLAMMABLE. DO NOT USE NEAR FLAME OR WHILE SMOKING. USE ONLY IN
VENTILATED AREAS.

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

entire scalp.

  • apply to affected areas one to four times daily or as directed by a doctor.
  • place package tip close to scalp on damp or dry hair and use 15 sprays to cover the

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol denat., water/eau, niacinamide, caffeine, BIS-PEG/PPG-16/16 PEG/PPG-16/16 dimethicone, glycerin, fragrance/parfum, acrylates/C10-30 alkyl acrylate crosspolymer, panthenol, tetrahydroxypropyl ethylenediamine.

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 ®

CLINICAL

SOLUTIONS



pyrithione zinc

dandruff treatment

LEAVE-ON DANDRUFF TREATMENT

24hr Protection

Dandruff * Itch * Irritation

CLINICALLY PROVEN

125 mL (4.2 FL OZ)
HS1HS1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-15269423-152-50, 69423-152-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
NIACINAMIDE25X51I8RD4IACT
GLYCERINPDC6A3C0OXIACT
CAFFEINE3G6A5W338EIACT
BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE55A74AJ3KBIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
PANTHENOLWV9CM0O67ZIACT
EDETOLQ4R969U9FRIACT

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
7d50a266-44b5-4b74-e053-2a91aa0a73d841963d1c-8dda-08ef-e054-00144ff8d46c2018-12-18WarningsExact identifier
spl set id: 41963d1c-8dda-08ef-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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