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Head and Shoulders

Head and Shoulders Smooth and Silky 2in1

Approved
Approval ID

6d1de62a-b1ab-4ae1-8b8d-e9f0b85beb59

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 27, 2025

Manufacturers
FDA

The Procter & Gamble Manufacturing Company

DUNS: 004238200

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Pyrithione Zinc

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code37000-095
Application NumberM032
Product Classification
M
Marketing Category
C200263
G
Generic Name
Pyrithione Zinc
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 27, 2025
FDA Product Classification

INGREDIENTS (14)

COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
ZINC CARBONATEInactive
Code: EQR32Y7H0M
Classification: IACT
GLYCOL DISTEARATEInactive
Code: 13W7MDN21W
Classification: IACT
SODIUM XYLENESULFONATEInactive
Code: G4LZF950UR
Classification: IACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)Inactive
Code: B16G315W7A
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
MAGNESIUM CARBONATE HYDROXIDEInactive
Code: YQO029V1L4
Classification: IACT
METHYLISOTHIAZOLINONEInactive
Code: 229D0E1QFA
Classification: IACT
PYRITHIONE ZINCActive
Quantity: 1 g in 100 mL
Code: R953O2RHZ5
Classification: ACTIB
METHYLCHLOROISOTHIAZOLINONEInactive
Code: DEL7T5QRPN
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 11/11/2017

PRINCIPAL DISPLAY PANEL - 380 mL Bottle Label

head &
** shoulders****®**

pyrithione zincdandruff

shampoo + conditioner

SMOOTH & SILKY

2in1

24 hour frizz control from root to tip

FLAKE FREE.*


** UP TO 100%**


** GUARANTEED^**

12.5 FL OZ (370 mL)
HS

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/22/2014

Uses

helps prevent recurrence of flaking and itching associated with dandruff.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/22/2014

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/22/2014

Active ingredient

Pyrithione zinc 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/22/2014

Purpose

Anti-dandruff

WARNINGS SECTION

LOINC: 34071-1Updated: 9/22/2014

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 product as directed.

**Keep this and all drugs out of reach of children.**If swallowed, get medical help or contact a Poison Control Center right away.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/22/2014

Questions (or comments)?

1-800-723-9569

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/22/2014

Directions

  • 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 INGREDIENT SECTION

LOINC: 51727-6Updated: 2/1/2025

Inactive ingredients

Water, sodium lauryl sulfate, glycol distearate, zinc carbonate, sodium chloride, cocamidopropyl betaine, fragrance, sodium xylenesulfonate, dimethicone, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, methylchloroisothiazolinone, methylisothiazolinone

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Head and Shoulders - FDA Drug Approval Details