FDA.reportPublic FDA data

Head and Shoulders MEN Advanced Series Bourbon 2in1

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:26:53

Label at a glance#

ProductHead and Shoulders MEN Advanced Series Bourbon 2in1
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, cocamidopropyl betaine, sodium xylenesulfonate, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, blue 1, red 33

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

ADVANCED SERIES

BOURBON

12.5 FL OZ

(370 mL)

HSHS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043244head & shoulders 1 % Medicated ShampooPSN5
209884zinc pyrithione 1 % Medicated ShampooPSN5
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD5
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD5
1043244Head & Shoulders 1 % Medicated ShampooSY5
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY5
209884zinc pyrithione 1 % Medicated ConditionerSY5
209884zinc pyrithione 1 % Medicated ShampooSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-412-382022-10-05C16284748780-1d6a99b39-39b1-a426-e053-dadaa90af4c2Head and Shoulders MEN ADVANCED SERIES BOURBON 2in1
69423-412-382022-01-28C16284748780-1d6a99b39-39b1-a426-e053-dadaa90af4c2Head and Shoulders MEN ADVANCED SERIES BOURBON 2in1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-412-37Head and Shoulders MEN Advanced Series Bourbon 2in1370 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO3705
69423-412-38Head and Shoulders MEN Advanced Series Bourbon 2in1380 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO3805
69423-412-83Head and Shoulders MEN Advanced Series Bourbon 2in1835 mL in 1 BOTTLE, PUMPLOTION/SHAMPOO8355
69423-412-93Head and Shoulders MEN Advanced Series Bourbon 2in1930 mL in 1 BOTTLE, PUMPLOTION/SHAMPOO9305

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-41269423-412-38, 69423-412-93, 69423-412-37, 69423-412-83

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
WATER059QF0KO0RIACT
D&C RED NO. 339DBA0SBB0LIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
GLYCOL DISTEARATE13W7MDN21WIACT
ZINC CARBONATEEQR32Y7H0MIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM BENZOATEOJ245FE5EUIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB

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 MEN Advanced Series Bourbon 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company98480eaa-6798-4efe-e053-2a95a90a869f2025-12-18WarningsExact identifier
ndc (package): 69423-412-38
ndc (package): 69423-412-93
ndc (package): 69423-412-37
ndc (package): 69423-412-83
ndc (product): 69423-412
ndc11 (package): 69423041238
ndc11 (package): 69423041237
ndc11 (package): 69423041293
ndc11 (package): 69423041283
spl id: 4640d93b-5d54-ea27-e063-6294a90ab4cf
spl set id: 98480eaa-6798-4efe-e053-2a95a90a869f

Reported adverse events (FAERS/openFDA)#

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