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Head and Shoulders Dual Pack

Head and Shoulders Dual Kit Smooth and Silky

Approved
Approval ID

a9500735-c938-0ad5-e053-2995a90afa50

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 14, 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 Code69423-210
Application NumberM032
Product Classification
M
Marketing Category
C200263
G
Generic Name
Pyrithione Zinc
Product Specifications
Effective DateMay 14, 2025
FDA Product Classification

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/31/2016

PRINCIPAL DISPLAY PANEL - Kit Package

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)

HS

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/31/2016

Uses

helps prevent recurrence of flaking and itching associated with dandruff.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/31/2016

Directions

  • 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.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/31/2016

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/31/2016

Active ingredient

Pyrithione zinc 0.5%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/31/2016

Purpose

Anti-dandruff

WARNINGS SECTION

LOINC: 34071-1Updated: 5/31/2016

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.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/31/2016

Inactive ingredients

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.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/31/2016

Questions (or comments)?

1-800-723-9569

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Head and Shoulders Dual Pack - FDA Drug Approval Details