SPL v2
SPL
SPL Set ID 1469154b-47d8-00a9-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2015-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (0.01 g)
Inactive Ingredients
Cyclohexyl Cinnamate Methylchloroisothiazolinone D&c Red No. 33 Sodium Chloride Sodium Xylenesulfonate Cocamidopropyl Betaine Sodium Benzoate Dimethicone Zinc Carbonate C.i. Acid Blue 324 Water Sodium Lauryl Sulfate Sodium Laureth Sulfate Glycol Distearate Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) Hydrochloric Acid Magnesium Carbonate Hydroxide Methylisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-04-23
Description

WARNININGS 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.

Medication Information

Warnings and Precautions

WARNININGS

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.

Indications and Usage

DIRECTIONS

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

Dosage and Administration

FOR EXTERNAL USE ONLY

FOR BEST RESULTS USE A LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR

Description

WARNININGS 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.

Section 50565-1

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN

Section 51727-6

Water,sodium laureth sulfate, sodium lauryl sulfate, cocamide mea, zinc carbonate, glycol distearate, dimethicone, fragance, guarhydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, sodium chloride, methylchloroisothiazolinone,methylisothiazolinone, sodium xylenesulfonate, blue 1, D&C red 33.

Section 51945-4

Section 55105-1

PURPOSE

Anti-drandruff

Section 55106-9

PYRITHIONE ZINC 1%

Structured Label Content

Indications and Usage (34067-9)

DIRECTIONS

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

Dosage and Administration (34068-7)

FOR EXTERNAL USE ONLY

FOR BEST RESULTS USE A LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR

Warnings and Precautions (34071-1)

WARNININGS

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.

Section 50565-1 (50565-1)

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN

Section 51727-6 (51727-6)

Water,sodium laureth sulfate, sodium lauryl sulfate, cocamide mea, zinc carbonate, glycol distearate, dimethicone, fragance, guarhydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, sodium chloride, methylchloroisothiazolinone,methylisothiazolinone, sodium xylenesulfonate, blue 1, D&C red 33.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

PURPOSE

Anti-drandruff

Section 55106-9 (55106-9)

PYRITHIONE ZINC 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:18.279988 · Updated: 2026-03-14T22:54:41.714370