FDA.reportPublic FDA data

Head and Shoulders 2in1 Men Vanilla and Amber

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-01-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:54:07

Label at a glance#

ProductHead and Shoulders 2in1 Men Vanilla and Amber
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

OTC - DO NOT USE 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 lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, dimethicone, fragrance, cocamidopropyl betaine, sodium xylenesulfonate, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

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 + conditioner

2in1

MEN

VANILLA & AMBER

FLAKE FREE.*
UP TO 100%
GUARANTEED

12.5 FL OZ

(370 mL)

HSHS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043244head & shoulders 1 % Medicated ShampooPSN1
209884zinc pyrithione 1 % Medicated ShampooPSN1
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD1
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD1
1043244Head & Shoulders 1 % Medicated ShampooSY1
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY1
209884zinc pyrithione 1 % Medicated ConditionerSY1
209884zinc pyrithione 1 % Medicated ShampooSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-082-37Head and Shoulders 2in1 Men Vanilla and Amber370 mL in 1 BOTTLE, PLASTICSHAMPOO3701

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-082HEAD AND SHOULDERS 2IN1 MEN VANILLA AND AMBER (PYRITHIONE ZINC) SHAMPOO [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 1 package rows20250201_2cf441e0-3ddd-0f9e-e063-6394a90a092c.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-08284126-082-37

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCOL DISTEARATE13W7MDN21WIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
ZINC CARBONATEEQR32Y7H0MIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
DIMETHICONE92RU3N3Y1OIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM BENZOATEOJ245FE5EUIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDEB16G315W7AIACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT

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 2in1 Men Vanilla and AmberPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company2cf441e0-3ddd-0f9e-e063-6394a90a092c2025-01-30WarningsExact identifier
ndc (package): 84126-082-37
ndc (product): 84126-082
ndc11 (package): 84126008237
spl id: 2cf441e0-3ddc-0f9e-e063-6394a90a092c
spl set id: 2cf441e0-3ddd-0f9e-e063-6394a90a092c

Reported adverse events (FAERS/openFDA)#

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