FDA.reportPublic FDA data

Head and Shoulders Shea Butter

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:30:55

Label at a glance#

ProductHead and Shoulders Shea Butter
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, dimethicone, cocamidopropyl betaine, fragrance, sodium xylenesulfonate, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, sodium laureth sulfate, butyrospermum parkii (shea) butter, yellow 5, red 33, blue 1

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

MADE IN U.S.A. of U.S. and/or Imported Ingredients

Dist. by PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 370 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

head &
shoulders ®

PYRITHIONE ZINC DANDRUFF SHAMPOO

SHEA BUTTER

SHAMPOO

Moisturize & cleanse

without stripping hair

FOR CURLY TO COILY HAIR

12.5 FL OZ (370 mL)

HSHS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043244head & shoulders 1 % Medicated ShampooPSN3
209884zinc pyrithione 1 % Medicated ShampooPSN3
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD3
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD3
1043244Head & Shoulders 1 % Medicated ShampooSY3
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY3
209884zinc pyrithione 1 % Medicated ConditionerSY3
209884zinc pyrithione 1 % Medicated ShampooSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-671-37Head and Shoulders Shea Butter370 mL in 1 BOTTLE, PLASTICSHAMPOO3703
69423-671-83Head and Shoulders Shea Butter835 mL in 1 BOTTLE, PUMPSHAMPOO8353

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-67169423-671-37, 69423-671-83

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM LAURETH SULFATEBPV390UAP0IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
SHEA BUTTERK49155WL9YIACT
SODIUM LAURYL SULFATE368GB5141JIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
ZINC CARBONATEEQR32Y7H0MIACT
GLYCOL DISTEARATE13W7MDN21WIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM BENZOATEOJ245FE5EUIACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
D&C RED NO. 339DBA0SBB0LIACT

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
Head and Shoulders Shea ButterPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyf80a1580-38ba-3dae-e053-6394a90aff5d2025-12-31WarningsExact identifier
ndc (package): 69423-671-37
ndc (package): 69423-671-83
ndc (product): 69423-671
ndc11 (package): 69423067183
ndc11 (package): 69423067137
spl id: 4745f4ce-210e-db9b-e063-6294a90a5807
spl set id: f80a1580-38ba-3dae-e053-6394a90aff5d

Reported adverse events (FAERS/openFDA)#

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