FDA.reportPublic FDA data

Head and Shoulders Tea Tree Oil 2in1

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-02-18
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:46:25

Label at a glance#

ProductHead and Shoulders Tea Tree 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

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, glycol distearate, zinc carbonate, sodium chloride, fragrance, cocamidopropyl betaine, sodium xylenesulfonate, dimethicone, menthol, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, sodium laureth sulfate, mentha piperita (peppermint) flower/leaf/stem oil, mentha arvensis leaf/stem oil, melaleuca alternifolia (tea tree) leaf oil, yellow 5, 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

TEA TREE
OIL

2in1

12.5 FL OZ (370 mL)

HSHS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043244head & shoulders 1 % Medicated ShampooPSN8
209884zinc pyrithione 1 % Medicated ShampooPSN8
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD8
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD8
1043244Head & Shoulders 1 % Medicated ShampooSY8
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY8
209884zinc pyrithione 1 % Medicated ConditionerSY8
209884zinc pyrithione 1 % Medicated ShampooSY8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-417-01Head and Shoulders Tea Tree Oil 2in1950 mL in 1 BOTTLE, PUMPLOTION/SHAMPOO9508
69423-417-01Head and Shoulders Tea Tree Oil 2in12 in 1 CELLO PACKLOTION/SHAMPOO28
69423-417-12Head and Shoulders Tea Tree Oil 2in11280 mL in 1 BOTTLE, PUMPLOTION/SHAMPOO12808
69423-417-37Head and Shoulders Tea Tree Oil 2in1370 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO3708
69423-417-40Head and Shoulders Tea Tree Oil 2in1400 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO4008
69423-417-61Head and Shoulders Tea Tree Oil 2in1610 mL in 1 BOTTLE, PUMPLOTION/SHAMPOO6108
69423-417-83Head and Shoulders Tea Tree Oil 2in1835 mL in 1 BOTTLE, PUMPLOTION/SHAMPOO8358
69423-417-95Head and Shoulders Tea Tree Oil 2in1950 mL in 1 BOTTLE, PUMPLOTION/SHAMPOO9508

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-41769423-417-40, 69423-417-95, 69423-417-12, 69423-417-37, 69423-417-83, 69423-417-01, 69423-417-61

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
TEA TREE OILVIF565UC2GIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
GLYCOL DISTEARATE13W7MDN21WIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
ZINC CARBONATEEQR32Y7H0MIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
DIMETHICONE92RU3N3Y1OIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM BENZOATEOJ245FE5EUIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
PEPPERMINT OILAV092KU4JHIACT

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 Tea Tree Oil 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company96b37f23-230f-0652-e053-2a95a90a1f642026-02-18WarningsExact identifier
ndc (package): 69423-417-95
ndc (package): 69423-417-12
ndc (package): 69423-417-40
ndc (package): 69423-417-01
ndc (package): 69423-417-83
ndc (package): 69423-417-37
ndc (package): 69423-417-61
ndc (product): 69423-417
ndc11 (package): 69423041795
ndc11 (package): 69423041701
ndc11 (package): 69423041712
ndc11 (package): 69423041737
ndc11 (package): 69423041740
ndc11 (package): 69423041783
ndc11 (package): 69423041761
spl id: 4b1ac2b1-a468-bc60-e063-6394a90a3062
spl set id: 96b37f23-230f-0652-e053-2a95a90a1f64

Reported adverse events (FAERS/openFDA)#

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