FDA.reportPublic FDA data

Head and Shoulders Clinical Strength Dandruff Defense Advanced Oil Control

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-09-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:12:41

Label at a glance#

ProductHead and Shoulders 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, hydroxypropyl methylcellulose, 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

Clinical Strength

Dandruff Defense

Advanced Oil Control

Extra Strength Formula

with Refreshing Citrus

13.5 FL OZ (400 mL)

HSHS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1549328Head & Shoulders Clinical Strength 1 % Medicated ShampooPSN4
204642selenium sulfide 1 % Medicated ShampooPSN4
1549328selenium sulfide 10 MG/ML Medicated Shampoo [Head & Shoulders Clinical Strength]SBD4
204642selenium sulfide 10 MG/ML Medicated ShampooSCD4
1549328Head & Shoulders Clinical Solutions 10 MG/ML Medicated ShampooSY4
1549328Head & Shoulders Clinical Strength 10 MG/ML Medicated ShampooSY4
204642selenium sulfide 1 % Lotion ShampooSY4
204642selenium sulfide 1 % Medicated ShampooSY4
1549328selenium sulfide 10 MG/ML Medicated Shampoo [Head & Shoulders Clinical Solutions]SY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-525-402023-05-08C16284748780-1d6a99b39-9a7b-a426-e053-dadaa90af4c2Head and Shoulders ® Clinical Strength Dandruff Defense Advanced Oil Control Shampoo
69423-525-402022-01-28C16284748780-1d6a99b39-9a7b-a426-e053-dadaa90af4c2Head and Shoulders ® Clinical Strength Dandruff Defense Advanced Oil Control Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-525-01Head and Shoulders Clinical Strength Dandruff Defense Advanced Oil Control2 in 1 CELLO PACKLOTION/SHAMPOO24
69423-525-01Head and Shoulders Clinical Strength Dandruff Defense Advanced Oil Control400 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO4004
69423-525-40Head and Shoulders Clinical Strength Dandruff Defense Advanced Oil Control400 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO4004

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
69423-52569423-525-40, 69423-525-01

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

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 Dandruff Defense Advanced Oil ControlSELENIUM SULFIDEThe Procter & Gamble Manufacturing Companyb6ad107b-024b-828f-e053-2995a90aae362025-09-04WarningsExact identifier
ndc (package): 69423-525-01
ndc (package): 69423-525-40
ndc (product): 69423-525
ndc11 (package): 69423052501
ndc11 (package): 69423052540
spl id: 3e00ce5a-97f5-466f-e063-6294a90a1d20
spl set id: b6ad107b-024b-828f-e053-2995a90aae36

Reported adverse events (FAERS/openFDA)#

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