FDA.reportPublic FDA data

Head and Shoulders Dual Sachets

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2020-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:02:51

Label at a glance#

ProductHead and Shoulders Dual Sachets Smooth and Silky
Active ingredientPYRITHIONE ZINC
Label structure18 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

head &
shoulders
instant relief
pyrithione zinc dandruff shampoo

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

For external use only.

When using this product

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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, sodium laureth sulfate, sodium lauryl sulfate, cocamide MEA, zinc carbonate, glycol distearate, fragrance, sodium xylenesulfonate, dimethicone, cetyl alcohol, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium chloride, sodium benzoate, magnesium carbonate hydroxide, benzyl alcohol, mentha piperita (peppermint) oil, menthol, mentha arvensis leaf oil, methylchloroisothiazolinone, methylisothiazolinone, yellow 5, blue 1.

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

head &
shoulders
instant relief
pyrithione zinc dandruff conditioner

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 0.5%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Uses

INDICATIONS & USAGE SECTION

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

WARNINGS SECTION

For external use only.

When using this product

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.
  • apply to wet hair after shampooing by gently massaging into hair and scalp, rinse well.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, stearyl alcohol, cetyl alcohol, stearamidopropyl dimethylamine, fragrance, dimethicone, glutamic acid, phenoxyethanol, benzyl alcohol, citric acid, sodium chloride, mentha piperita (peppermint) oil, menthol, mentha arvensis leaf oil, methylchloroisothiazolinone, methylisothiazolinone, yellow 5, blue 1.

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - Kit Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

head &
shoulders ®

pyrithione zinc dandruff shampoo

smooth & silky

24 hour frizz control from root to tip

FLAKE FREE.*
UP TO 100%
COLOR SAFE

0.34 FL OZ (10 mL)

head &
shoulders ®

pyrithione zinc dandruff conditioner

smooth & silky

24 hour frizz control from root to tip

0.34 FL OZ (10 mL)

HSHS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1441654{1 (10 ML) (zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]) / 1 (10 ML) (zinc pyrithione 5 MG/ML Medicated Shampoo [Head & Shoulders]) } Pack [Head & Shoulders Dual Sachets]BPCK2
1441653{1 (10 ML) (zinc pyrithione 10 MG/ML Medicated Shampoo) / 1 (10 ML) (zinc pyrithione 5 MG/ML Medicated Shampoo) } PackGPCK2
1044465head & shoulders 0.5 % Medicated ShampooPSN2
1043244head & shoulders 1 % Medicated ShampooPSN2
1441654Head & Shoulders Dual Sachets PackPSN2
1043014zinc pyrithione 0.5 % Medicated ConditionerPSN2
209884zinc pyrithione 1 % Medicated ShampooPSN2
1441653zinc pyrithione 1 % Medicated Shampoo (10 ML) / zinc pyrithione 0.5 % Medicated Conditioner (10 ML) PackPSN2
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD2
1044465zinc pyrithione 5 MG/ML Medicated Shampoo [Head & Shoulders]SBD2
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD2
1043014zinc pyrithione 5 MG/ML Medicated ShampooSCD2
1044465Head & Shoulders 0.5 % ConditionerSY2
1043244Head & Shoulders 1 % Medicated ShampooSY2
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY2
1044465Head & Shoulders 5 MG/ML Medicated ShampooSY2
1441654Head & Shoulders Dual Sachets PackSY2
1441654Head & Shoulders Dual Sachets Pack (1 (0.34 FL OZ) (zinc pyrithione 1 % Medicated Shampoo [Head & Shoulders]) / 1 (0.34 FL OZ) (zinc pyrithione 0.5 % Medicated Conditioner [Head & Shoulders]))SY2
1043014zinc pyrithione 0.5 % Medicated ShampooSY2
209884zinc pyrithione 1 % Medicated ConditionerSY2
209884zinc pyrithione 1 % Medicated ShampooSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-296-012022-01-28C16284748780-1d6a99b39-d379-a426-e053-dadaa90af4c2Head and Shoulders ® Dual Sachets Smooth and Silky

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-094-10Head and Shoulders Dual SachetsSmooth and Silky10 mL in 1 POUCHLOTION/SHAMPOO10 mL1 g in 100mL2
69423-103-10Head and Shoulders Dual SachetsSmooth and Silky10 mL in 1 POUCHLOTION10 mL0.5 g in 100mL2
69423-296-01Head and Shoulders Dual SachetsSmooth and Silky1 in 1 PACKAGE, COMBINATIONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-094HEAD AND SHOULDERS DUAL SACHETS SMOOTH AND SILKY (PYRITHIONE ZINC) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]2Current NDC, Legacy NDC20200110_7a2c32f7-182b-8959-e053-2991aa0a3a12.zip
69423-103HEAD AND SHOULDERS DUAL SACHETS SMOOTH AND SILKY (PYRITHIONE ZINC) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]2Current NDC, Legacy NDC20200110_7a2c32f7-182b-8959-e053-2991aa0a3a12.zip
69423-296HEAD AND SHOULDERS DUAL SACHETS SMOOTH AND SILKY (PYRITHIONE ZINC) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]2Legacy NDC, 3 package rows20200110_7a2c32f7-182b-8959-e053-2991aa0a3a12.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-29669423-296-01
37000-09437000-094-10
69423-10369423-103-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
WATER059QF0KO0RIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
SODIUM LAURYL SULFATE368GB5141JIACT
COCO MONOETHANOLAMIDEC80684146DIACT
ZINC CARBONATEEQR32Y7H0MIACT
GLYCOL DISTEARATE13W7MDN21WIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
DIMETHICONE92RU3N3Y1OIACT
CETYL ALCOHOL936JST6JCNIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM BENZOATEOJ245FE5EUIACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
BENZYL ALCOHOLLKG8494WBHIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
WATER059QF0KO0RIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CETYL ALCOHOL936JST6JCNIACT
STEARAMIDOPROPYL DIMETHYLAMINEK7VEI00UFRIACT
DIMETHICONE92RU3N3Y1OIACT
GLUTAMIC ACID3KX376GY7LIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZYL ALCOHOLLKG8494WBHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CHLORIDE451W47IQ8XIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Head and Shoulders Conditioner Smooth and SilkyPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company41709710-539c-3119-e054-00144ff88e882025-12-18WarningsExact identifier
ndc (package): 69423-103-10
ndc (product): 69423-103
ndc11 (package): 69423010310
9bb74582-2437-fe1d-e053-2995a90a98687a2c32f7-182b-8959-e053-2991aa0a3a122020-01-09WarningsExact identifier
spl id: 9bb74582-2437-fe1d-e053-2995a90a9868
spl set id: 7a2c32f7-182b-8959-e053-2991aa0a3a12

Reported adverse events (FAERS/openFDA)#

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