FDA.reportPublic FDA data

Head and Shoulders 2in1 Clinical Strength Cooling Itch Relief

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-10-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:15:46

Label at a glance#

ProductHead and Shoulders 2in1 Clinical Strength Cooling Itch Relief
Active ingredientSELENIUM SULFIDE
Label structure10 sections

Indications and uses

helps prevent recurrence of flaking, itching, irritation, scaling and redness associated with dandruff and seborrheic dermatitis.

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. caution: if used on bleached, tinted, grey, or permed hair, rinse for 5 minutes.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Selenium Sulfide 1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff, anti-seborrheic dermatitis

Uses

INDICATIONS & USAGE SECTION

helps prevent recurrence of flaking, itching, irritation, scaling and redness associated with dandruff and seborrheic dermatitis.

Warnings

WARNINGS SECTION

For external use only.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have a condition that covers a large area of the body.

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.
  • caution: if used on bleached, tinted, grey, or permed hair, rinse for 5 minutes.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, sodium lauryl sulfate, glycol distearate, sodium chloride, cocamidopropyl betaine, sodium citrate, dimethicone, sodium
xylenesulfonate, fragrance, menthol, citric acid, sodium benzoate, tetrasodium EDTA, mentha piperita (peppermint) flower/leaf/stem oil, mentha arvensis leaf/stem oil

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 400 mL BOTTLE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

head &

shoulders ®
selenium sulfide dandruff &

seborrheic dermatitis shampoo

2in1

Clinical Strength

Cooling

Itch Relief

13.5 FL OZ (400 mL)

HSHS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1549328Head & Shoulders Clinical Strength 1 % Medicated ShampooPSN1
204642selenium sulfide 1 % Medicated ShampooPSN1
1549328selenium sulfide 10 MG/ML Medicated Shampoo [Head & Shoulders Clinical Strength]SBD1
204642selenium sulfide 10 MG/ML Medicated ShampooSCD1
1549328Head & Shoulders Clinical Solutions 10 MG/ML Medicated ShampooSY1
1549328Head & Shoulders Clinical Strength 10 MG/ML Medicated ShampooSY1
204642selenium sulfide 1 % Lotion ShampooSY1
204642selenium sulfide 1 % Medicated ShampooSY1
1549328selenium sulfide 10 MG/ML Medicated Shampoo [Head & Shoulders Clinical Solutions]SY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-184-40Head and Shoulders 2in1 Clinical Strength Cooling Itch Relief400 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO4001

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
84126-18484126-184-40

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
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
PEPPERMINT OILAV092KU4JHIACT
TETRASODIUM EDTAMP1J8420LUIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
GLYCOL DISTEARATE13W7MDN21WIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM BENZOATEOJ245FE5EUIACT
SELENIUM SULFIDEZ69D9E381QACTIB
SODIUM CITRATE1Q73Q2JULRIACT
CITRIC ACID2968PHW8QPIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT

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 Clinical Strength Cooling Itch ReliefSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company4046c345-e1ac-0ecc-e063-6294a90a59fa2025-10-03WarningsExact identifier
ndc (package): 84126-184-40
ndc (product): 84126-184
ndc11 (package): 84126018440
spl id: 4046e575-4226-cf65-e063-6394a90a4cd7
spl set id: 4046c345-e1ac-0ecc-e063-6294a90a59fa

Reported adverse events (FAERS/openFDA)#

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