FDA.reportPublic FDA data

Head and Shoulders Detox and Refresh

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2020-06-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:23:38

Label at a glance#

ProductHead and Shoulders Detox and Refresh
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

SPL UNCLASSIFIED SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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 laureth sulfate, zinc carbonate,glycol distearate, cocamide MEA, cocamidopropyl betaine, fragrance, sodium xylenesulfonate, sodium chloride, dimethicone, menthol, guar hydroxypropyltrimonium chloride, sodium benzoate, polyquaternium-10, stearyl alcohol, magnesium carbonate hydroxide, cetyl alcohol, mentha piperita (peppermint) oil,

mentha arvensis leaf oil, methylchloroisothiazolinone, methylisothiazolinone, yellow 5, blue1.

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 380 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

head &

shoulders

PYRITHIONE ZINC DANDRUFF SHAMPOO

DETOX & REFRESH

SHAMPOO

REINVIGORATES SCALP AND DEEPLY

CLEANSES HAIR TO RESTORE SHINE

WITH CUCUMBER ESSENCE

AND MENTHOL

FLAKE FREE

UP TO 100%

GUARANTEED

12.8 FL OZ (380 mL)

HSHS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-321-382020-02-06C16284748780-19d75b9cf-e921-f424-e053-dadaa90a57ceHead and Shoulders ® Detox & Refresh Shampoo
69423-321-382020-01-31C16284748780-19d75b9cf-e921-f424-e053-dadaa90a57ceHead and Shoulders ® Detox & Refresh Shampoo

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-32169423-321-38

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARYL ALCOHOL2KR89I4H1YIACT
WATER059QF0KO0RIACT
COCO MONOETHANOLAMIDEC80684146DIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
GLYCOL DISTEARATE13W7MDN21WIACT
ZINC CARBONATEEQR32Y7H0MIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM BENZOATEOJ245FE5EUIACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
MENTHOLL7T10EIP3AIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
POLYQUATERNIUM-10 (30000 MPA.S AT 2%)C7RDC8Y4JSIACT
CETYL ALCOHOL936JST6JCNIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
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
a953bc39-0e2c-8710-e053-2a95a90a4b527cd755b7-58f1-16f6-e053-2a91aa0ac6122020-06-30WarningsExact identifier
spl id: a953bc39-0e2c-8710-e053-2a95a90a4b52
spl set id: 7cd755b7-58f1-16f6-e053-2a91aa0ac612

Reported adverse events (FAERS/openFDA)#

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