FDA.reportPublic FDA data

Head and Shoulders Lemon Oil 2in1

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:30:45

Label at a glance#

ProductHead and Shoulders Lemon Oil 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

SPL UNCLASSIFIED 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, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, dimethicone, cocamidopropyl betaine, sodium xylenesulfonate, fragrance, sodium benzoate, menthol, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, yellow5, blue 1

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

LEMON

OIL

2IN1

12.5 FL OZ (370 mL)

HSHS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043244head & shoulders 1 % Medicated ShampooPSN4
209884zinc pyrithione 1 % Medicated ShampooPSN4
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD4
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD4
1043244Head & Shoulders 1 % Medicated ShampooSY4
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY4
209884zinc pyrithione 1 % Medicated ConditionerSY4
209884zinc pyrithione 1 % Medicated ShampooSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-620-37Head and Shoulders Lemon Oil 2in1370 mL in 1 BOTTLE, PLASTICSHAMPOO3704
69423-620-40Head and Shoulders Lemon Oil 2in1400 mL in 1 BOTTLE, PLASTICSHAMPOO4004
69423-620-83Head and Shoulders Lemon Oil 2in1835 mL in 1 BOTTLE, PUMPSHAMPOO8354
69423-620-95Head and Shoulders Lemon Oil 2in1950 mL in 1 BOTTLE, PLASTICSHAMPOO9504

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
69423-62069423-620-40, 69423-620-95, 69423-620-37, 69423-620-83

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
BLUE 1H3R47K3TBDIACT
YELLOW 5I753WB2F1MIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
WATER059QF0KO0RIACT
ZINC CARBONATEEQR32Y7H0MIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCOL DISTEARATE13W7MDN21WIACT
DIMETHICONE92RU3N3Y1OIACT
MENTHOLL7T10EIP3AIACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDEB16G315W7AIACT
SODIUM BENZOATEOJ245FE5EUIACT
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 Lemon Oil 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Companye7903f3d-9c5a-f397-e053-2995a90a78952025-12-31WarningsExact identifier
ndc (package): 69423-620-40
ndc (package): 69423-620-95
ndc (package): 69423-620-83
ndc (package): 69423-620-37
ndc (product): 69423-620
ndc11 (package): 69423062040
ndc11 (package): 69423062037
ndc11 (package): 69423062095
ndc11 (package): 69423062083
spl id: 47450633-bcd4-6f07-e063-6294a90a96b1
spl set id: e7903f3d-9c5a-f397-e053-2995a90a7895

Reported adverse events (FAERS/openFDA)#

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