FDA.reportPublic FDA data

HEAD AND SHOULDER

Manufacturer
All Natural Dynamics | Procter and Gamble Manufacturara SA De CV
Effective date
2022-05-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:49:33

Label at a glance#

ProductHEAD AND SHOULDER MEN OLD SPICE
Active ingredientPYRITHIONE ZINC
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

DRUGS FACTS

ACTIVE INGREDIENTS

Pyrithione zinc 1%

OTC - PURPOSE SECTION

PURPOSE

Anti-dandruff

USER SAFETY WARNINGS SECTION

USES

Help prevent recurrence of flaking and itching associated with dan druff

WARNINGS SECTION

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

Avoid contact with eyes. if contact occurs, rinse eyes thoroughly with water.

STOP USE AND ASK A DOCTOR IF

condition worsens or does not improve after regular use of this procuct 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 rigth away.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

  • for best results use at least twice a week or as directed by doctor.
  • for maximun dandruff control, use every time you shampoo
  • shake bedore use
  • wet hair, message onto scalp, rinse, repeat if desired.

INACTIVE INGREDIENT SECTION

WATER, SODIUM LAURYL SULFATE, SODIUM LAURETH SULDATE, GLYCOL DISTEARATE , ZINC CARBONATE, SODIUM CHLORIDE, SODIUM XYLENESULFONATE, COCAMIDOPROPYL BETAINE, FRAGANCE, DIMETHICONE, SODIUM BENZOATE, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, MAGNESIUM CARBONATE HYDROXIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1, RED 33

INDICATIONS & USAGE SECTION

HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pyrithione zincpyrithione zincHEAD AND SHOULDERS MEN OLD SPICEHEAD AND SHOULDERS MEN OLD SPICE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043244head & shoulders 1 % Medicated ShampooPSN2
209884zinc pyrithione 1 % Medicated ShampooPSN2
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD2
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD2
1043244Head & Shoulders 1 % Medicated ShampooSY2
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY2
209884zinc pyrithione 1 % Medicated ConditionerSY2
209884zinc pyrithione 1 % Medicated ShampooSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51769-427-012024-01-30C16284748780-11030e365-0cc6-111a-e063-dadaa90a10e2deb250bb-4019-024a-e053-2995a90ac5b4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51769-427-01HEAD AND SHOULDERMEN OLD SPICE650 mg in 1 BOTTLE, PLASTICLOTION/SHAMPOO6502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51769-427HEAD AND SHOULDER MEN OLD SPICE (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]2Legacy NDC, 1 package rows20220511_deb250bb-4019-024a-e053-2995a90ac5b4.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51769-42751769-427-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
PYRITHIONE ZINCR953O2RHZ5ACTIB
WATER059QF0KO0RIACT
ZINC CARBONATEEQR32Y7H0MIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM BENZOATEOJ245FE5EUIACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
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
deb250d1-e9cc-ce20-e053-2a95a90a2f8ddeb250bb-4019-024a-e053-2995a90ac5b42022-05-10WarningsExact identifier
spl id: deb250d1-e9cc-ce20-e053-2a95a90a2f8d
spl set id: deb250bb-4019-024a-e053-2995a90ac5b4

Reported adverse events (FAERS/openFDA)#

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