FDA.reportPublic FDA data

Head and Shoulders 2in1 Clinical Strength Dandruff Defense Advanced Oil Control

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2024-11-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:48:32

Label at a glance#

ProductHead and Shoulders 2in1 Clinical Strength Dandruff Defense Advanced Oil Control
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, ammonium laureth sulfate, ammonium lauryl sulfate, glycol distearate, cocamide MEA, ammonium xylenesulfonate, fragrance, sodium citrate, dimethicone, cetyl alcohol, citric acid, sodium chloride, sodium benzoate, disodium EDTA, stearyl alcohol, hydroxypropylmethylcellulose,methylchloroisothiazolinone, methylisothiazolinone, red 4.

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

2in1

Clinical Strength

Dandruff Defense

Extra Strength Formula

with Refreshing Citrus

13.5 FL OZ (400 mL)

HSHS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-524-402023-06-13C16284748780-1d6a99b39-ce72-a426-e053-dadaa90af4c2Head and Shoulders ® Clinical Strength 2in1 Dandruff Defense Advanced Oil Control Shampoo
69423-524-402022-01-28C16284748780-1d6a99b39-ce72-a426-e053-dadaa90af4c2Head and Shoulders ® Clinical Strength 2in1 Dandruff Defense Advanced Oil Control Shampoo

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-524HEAD AND SHOULDERS 2IN1 CLINICAL STRENGTH DANDRUFF DEFENSE ADVANCED OIL CONTROL (SELENIUM SULFIDE) LOTION/SHAMPOO [THE PROCTER & GAMBLE MANUFACTURING COMPANY]3Legacy NDC20241128_b6acfa78-3373-50d5-e053-2995a90a12bd.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-52469423-524-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETATE DISODIUM7FLD91C86KIACT
COCO MONOETHANOLAMIDEC80684146DIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CETYL ALCOHOL936JST6JCNIACT
WATER059QF0KO0RIACT
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
GLYCOL DISTEARATE13W7MDN21WIACT
SODIUM CHLORIDE451W47IQ8XIACT
AMMONIUM XYLENESULFONATE4FZY6L6XCMIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM BENZOATEOJ245FE5EUIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
SELENIUM SULFIDEZ69D9E381QACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
FD&C RED NO. 4X3W0AM1JLXIACT
SODIUM CITRATE1Q73Q2JULRIACT

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
27e70f34-9bbf-26cc-e063-6394a90ab496b6acfa78-3373-50d5-e053-2995a90a12bd2024-11-27WarningsExact identifier
spl id: 27e70f34-9bbf-26cc-e063-6394a90ab496
spl set id: b6acfa78-3373-50d5-e053-2995a90a12bd

Reported adverse events (FAERS/openFDA)#

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