Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 335ba153-f1d0-4ee3-9cee-604d85e86187
Route
TOPICAL
Published
Effective Date 2012-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (1 mL)
Inactive Ingredients
Water Sodium Laureth Sulfate Sodium Lauryl Sulfate Coco Monoethanolamide Glycol Distearate Sodium Chloride Dimethicone Zinc Sulfate Polyquaternium-10 (400 Cps At 2%) Cetyl Alcohol Trolamine Benzyl Alcohol Methylchloroisothiazolinone Methylisothiazolinone Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-07-15
Description

Active Ingredient Pyrithione zinc 1%

Medication Information

Warnings and Precautions
W arnings

 For external use only

Indications and Usage

Uses • helps to treat flakes, itch, irritation, oilness or dryness caused by dandruff.

Dosage and Administration

Directions •wet hair, •squeeze small amount into palm •lather, •rinse well

Description

Active Ingredient Pyrithione zinc 1%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if condition does not improve or worsen after regular use of this product as directed

Section 50567-7

When using this product •avoid contact with eyes • if contact occurs, rinse eyes with plenty of water.

Section 51727-6
Inactive Ingredients   water, sodium laureth sulfate, sodium lauryl sulfate, cocamide MEA, glycol distearate, sodium chloride, acrylates copolymer, dimethicone, zinc sulfate, fragrance, polyquaterinum-10, cetyl alcohol, triethanolamine, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, FDC blue no.1
Section 51945-4

package label

Section 55105-1
Purpose

Anti-dandruff
Section 55106-9

Active Ingredient

Pyrithione zinc 1%

Structured Label Content

Indications and Usage (34067-9)

Uses • helps to treat flakes, itch, irritation, oilness or dryness caused by dandruff.

Dosage and Administration (34068-7)

Directions •wet hair, •squeeze small amount into palm •lather, •rinse well

Warnings and Precautions (34071-1)
W arnings

 For external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition does not improve or worsen after regular use of this product as directed

Section 50567-7 (50567-7)

When using this product •avoid contact with eyes • if contact occurs, rinse eyes with plenty of water.

Section 51727-6 (51727-6)
Inactive Ingredients   water, sodium laureth sulfate, sodium lauryl sulfate, cocamide MEA, glycol distearate, sodium chloride, acrylates copolymer, dimethicone, zinc sulfate, fragrance, polyquaterinum-10, cetyl alcohol, triethanolamine, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, FDC blue no.1
Section 51945-4 (51945-4)

package label

Section 55105-1 (55105-1)
Purpose

Anti-dandruff
Section 55106-9 (55106-9)

Active Ingredient

Pyrithione zinc 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:29.876329 · Updated: 2026-03-14T22:53:14.066899