FDA.reportPublic FDA data

Head and Shoulders Clinical Strength Dry Scalp Rescue

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-04-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:58:59

Label at a glance#

ProductHead and Shoulders Clinical Strength Dry Scalp Rescue
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, fragrance, cocamidopropyl betaine, sodium citrate, sodium xylenesulfonate, dimethicone, citric acid, sodium benzoate, tetrasodium EDTA, menthol, mentha piperita (peppermint) flower/leaf/stemoil, 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 - BOTTLE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

head &

shoulders ®
selenium sulfide dandruff &

seborrheic dermatitis shampoo

Clinical Strength

Dry Scalp

Rescue

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
84126-108-01Head and Shoulders Clinical Strength Dry Scalp Rescue2 in 1 CARTONSHAMPOO21
84126-108-01Head and Shoulders Clinical Strength Dry Scalp Rescue400 mL in 1 BOTTLE, PLASTICSHAMPOO4001
84126-108-40Head and Shoulders Clinical Strength Dry Scalp Rescue400 mL in 1 BOTTLE, PLASTICSHAMPOO4001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-108HEAD AND SHOULDERS CLINICAL STRENGTH DRY SCALP RESCUE (SELENIUM SULFIDE) SHAMPOO [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 3 package rows20250412_3272a482-3813-63e4-e063-6394a90a43eb.zip

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
84126-10884126-108-40, 84126-108-01

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
MENTHOLL7T10EIP3AIACT
PEPPERMINTV95R5KMY2BIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
TETRASODIUM EDTAMP1J8420LUIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
GLYCOL DISTEARATE13W7MDN21WIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM BENZOATEOJ245FE5EUIACT
SELENIUM SULFIDEZ69D9E381QACTIB
SODIUM CITRATE1Q73Q2JULRIACT
CITRIC ACID2968PHW8QPIACT

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 Clinical Strength Dry Scalp RescueSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company3272a482-3813-63e4-e063-6394a90a43eb2025-04-10WarningsExact identifier
ndc (package): 84126-108-40
ndc (package): 84126-108-01
ndc (product): 84126-108
ndc11 (package): 84126010801
ndc11 (package): 84126010840
spl id: 3272a450-3e6e-643a-e063-6394a90a8aef
spl set id: 3272a482-3813-63e4-e063-6394a90a43eb

Reported adverse events (FAERS/openFDA)#

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