FDA.reportPublic FDA data

Head and Shoulders Calming Lavender Daily

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-03-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:33:37

Label at a glance#

ProductHead and Shoulders Calming Lavender 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.

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

  • 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 lauryl sulfate, glycol distearate, zinc carbonate, sodium chloride, fragrance, cocamidopropyl betaine, sodium xylenesulfonate, dimethicone, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, sodium laureth sulfate, methylchloroisothiazolinone, lavandula angustifolia (lavender) flower extract, methylisothiazolinone.

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 380 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

head &

shoulders ®

pyrithione zinc dandruff shampoo

CALMING

LAVENDER

DAIILY SHAMPOO

CALMING SHAMPOO

INFUSED WITH LAVENDER +

JASMINE ESSENCE

UP TO 100%

COLOR SAFE

FLAKE FREE*

12.8 FL OZ (380 mL)

HSHS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-325-382023-02-27C16284748780-19d75b9d0-5e12-f424-e053-dadaa90a57ceHead and Shoulders ® Calming Lavender Daily Shampoo
69423-325-382022-01-28C16284748780-19d75b9d0-5e12-f424-e053-dadaa90a57ceHead and Shoulders ® Calming Lavender Daily Shampoo
69423-325-382020-02-06C16284748780-19d75b9d0-5e12-f424-e053-dadaa90a57ceHead and Shoulders ® Calming Lavender Daily Shampoo
69423-325-382020-01-31C16284748780-19d75b9d0-5e12-f424-e053-dadaa90a57ceHead and Shoulders ® Calming Lavender Daily Shampoo

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
69423-32569423-325-38

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
WATER059QF0KO0RIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
DIMETHICONE92RU3N3Y1OIACT
ZINC CARBONATEEQR32Y7H0MIACT
GLYCOL DISTEARATE13W7MDN21WIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM BENZOATEOJ245FE5EUIACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
SODIUM LAURYL SULFATE368GB5141JIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT

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
f8336c4a-9e96-b8d2-e053-6394a90a5dfe7cd90cce-1aee-2d1f-e053-2a91aa0a20832023-03-31WarningsExact identifier
spl id: f8336c4a-9e96-b8d2-e053-6394a90a5dfe
spl set id: 7cd90cce-1aee-2d1f-e053-2a91aa0a2083

Reported adverse events (FAERS/openFDA)#

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