Drug Facts Box - Back Label

Drug Facts Box - Back Label
SPL v1
SPL
SPL Set ID 436f4db5-a7ff-4a29-99f2-3593898dda3e
Route
TOPICAL
Published
Effective Date 2010-09-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (1 mL)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-09-16
Description

PYRITHIONE ZINC 1%

Purpose

ANTI-DANDRUFF

Medication Information

Purpose
ANTI-DANDRUFF
Description

PYRITHIONE ZINC 1%

Uses
HELPS PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF
Warnings

FOR EXTERNAL USE ONLY

Directions
FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO. WET HAIR, MASSAGE ONTO SCALP AND RINSE. REPEAT IF DESIRE.
Active Ingredient

PYRITHIONE ZINC 1%

Inactive Ingredients

Water (Aqua), Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Cocamide MEA, Zinc Carbonate, Glycol Distearate, Dimethicone, Fragrance (Parfum), Cetyl Alcohol, Guar Hydroxypropyltrimonium Chloride, Magnesium Sulfate, Sodium Benzoate, Magnesium Carbonate Hydroxide, Ammonium Laureth Sulfate, Benzyl Alcohol, Sodium Chloride, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Xylene Sulfonate, Blue 1 (CI 42090), Red 4 (CI 14700), Menthol.

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THROUGHLY WITH WATER.

Stop Use and Ask A Doctor If

CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER IMMEDIATELY.



Package Front and Back Labels

eql14.jpg

Structured Label Content

Uses
HELPS PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF
Purpose (PURPOSE)
ANTI-DANDRUFF
Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Directions
FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO. WET HAIR, MASSAGE ONTO SCALP AND RINSE. REPEAT IF DESIRE.
Active Ingredient (ACTIVE INGREDIENT)

PYRITHIONE ZINC 1%

Inactive Ingredients

Water (Aqua), Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Cocamide MEA, Zinc Carbonate, Glycol Distearate, Dimethicone, Fragrance (Parfum), Cetyl Alcohol, Guar Hydroxypropyltrimonium Chloride, Magnesium Sulfate, Sodium Benzoate, Magnesium Carbonate Hydroxide, Ammonium Laureth Sulfate, Benzyl Alcohol, Sodium Chloride, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Xylene Sulfonate, Blue 1 (CI 42090), Red 4 (CI 14700), Menthol.

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THROUGHLY WITH WATER.

Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)

CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER IMMEDIATELY.



Package Front and Back Labels

eql14.jpg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:07.925832 · Updated: 2026-03-14T22:52:28.188101