FDA.reportPublic FDA data

Head and Shoulders Repair and Protect

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2019-06-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:20:22

Label at a glance#

ProductHead and Shoulders Repair and Protect
Active ingredientPYRITHIONE ZINC
Label structure10 sections

Dosage and administration

for best results use at least twice a week or as directed by a doctor. for maximum dandruff control, use every time you shampoo. shake before use. wet hair, massage onto scalp. Leave on for several minutes. Rinse. Repeat if desired.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Selenium sulfide 1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff,Anti-seborrheic dermatitis

Use

INDICATIONS & USAGE SECTION

for the relief of scalp itch, irritation, redness and flaking associated with dandruff and seborrheic dermatitis.

Warnings

WARNINGS SECTION

For external use only.

Ask a doctor before use if you have a condition that covers a large area of the body.

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 OR PRIOR TO USE IN
    CHILDREN UNDER 2 YEARS.

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.
  • for maximum dandruff control, use every time you shampoo.
  • shake before use.
  • wet hair, massage onto scalp. Leave on for several minutes. Rinse.
    Repeat if desired.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, ammonium laureth sulfate, ammonium lauryl sulfate, glycol distearate, cocamide MEA, ammonium xylenesulfonate, sodium citrate, fragrance, dimethicone, cetyl alcohol, sodium chloride, citric acid, sodium benzoate, stearyl alcohol, disodium EDTA, hydroxypropyl methylcellulose, mentha piperita (peppermint) oil, menthol, mentha arvensis leaf oil, methylchloroisothiazolinone, methylisothiazolinone.

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 130 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

head &

shoulders ®

CLINICAL SOLUTIONS

SELENIUM SULFIDE

DANDRUFF & SEBORRHEIC DERMATITIS SHAMPOO

DANDRUFF SHAMPOO

Up to 7-Day Protection

Dandruff * Flaking * Seborrheic Dermatitis


CLINICALLY PROVEN

130 mL (4.3 FL OZ)

HS1HS1

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-15369423-153-13, 69423-153-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCO MONOETHANOLAMIDEC80684146DIACT
WATER059QF0KO0RIACT
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
GLYCOL DISTEARATE13W7MDN21WIACT
DIMETHICONE92RU3N3Y1OIACT
AMMONIUM XYLENESULFONATE4FZY6L6XCMIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM BENZOATEOJ245FE5EUIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
CETYL ALCOHOL936JST6JCNIACT
SODIUM CITRATE1Q73Q2JULRIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
STEARYL ALCOHOL2KR89I4H1YIACT
EDETATE DISODIUM7FLD91C86KIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
PEPPERMINT OILAV092KU4JHIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
MENTHOLL7T10EIP3AIACT

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
8c278b6f-d343-b750-e053-2995a90ad7e94197325c-8026-36d6-e054-00144ff8d46c2019-06-25WarningsExact identifier
spl id: 8c278b6f-d343-b750-e053-2995a90ad7e9
spl set id: 4197325c-8026-36d6-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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