FDA.reportPublic FDA data

Head and Shoulders Purely Gentle Daily

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2020-02-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:41:54

Label at a glance#

ProductHead and Shoulders Purely Gentle Daily
Active ingredientPYRITHIONE ZINC
Label structure10 sections

Indications and uses

helps prevent recurrence of flaking and itching associated with dandruff.

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, rinse, repeat if 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

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

WARNINGS 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

  • 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, rinse, repeat if desired.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, sodium laureth sulfate, zinc carbonate, glycol distearate, cocamide MEA, cocamidopropyl betaine, sodium xylenesulfonate, sodium chloride, dimethicone, guar hydroxypropyltrimonium chloride, sodium benzoate, polyquaternium-10, stearyl alcohol, magnesium carbonate hydroxide, cetyl alcohol, aloe barbadensis leaf juice, 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 - 400 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

head &

shoulders

Pyrithione Zinc DANDRUFF SHAMPOO

PURELY

GENTLE

DAILY SHAMPOO

HYPOALLERGENIC,

DYE-FREE,

FRAGRANCE-FREE FORMULA

INFUSED WITH ALOE VERA

13.5 FL OZ (400 mL)

HSHS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-295-402020-02-04C16284748780-19d75b9d0-993a-f424-e053-dadaa90a57ceHead and Shoulders ® Purely Gentle Daily Shampooo
69423-295-402020-01-31C16284748780-19d75b9d0-993a-f424-e053-dadaa90a57ceHead and Shoulders ® Purely Gentle Daily Shampooo

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
69423-29569423-295-40

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
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
GLYCOL DISTEARATE13W7MDN21WIACT
ZINC CARBONATEEQR32Y7H0MIACT
SODIUM CHLORIDE451W47IQ8XIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
SODIUM BENZOATEOJ245FE5EUIACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
ALOE VERA LEAFZY81Z83H0XIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
COCO MONOETHANOLAMIDEC80684146DIACT
CETYL ALCOHOL936JST6JCNIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
STEARYL ALCOHOL2KR89I4H1YIACT
POLYQUATERNIUM-10 (30000 MPA.S AT 2%)C7RDC8Y4JSIACT

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
9dc7d5ec-df3c-fd77-e053-2a95a90a17ba7c255ccc-5caa-6c07-e053-2a91aa0ae37e2020-02-04WarningsExact identifier
spl id: 9dc7d5ec-df3c-fd77-e053-2a95a90a17ba
spl set id: 7c255ccc-5caa-6c07-e053-2a91aa0ae37e

Reported adverse events (FAERS/openFDA)#

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