Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 39c643ed-ee24-498e-b66f-6c9c42038f07
Route
TOPICAL
Published
Effective Date 2012-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (1.0 mL)
Inactive Ingredients
Water Ammonium Laureth-2 Sulfate Ammonium Lauryl Sulfate Sodium Chloride Glycol Distearate Dimethicone Citric Acid Monohydrate Sodium Citrate Ammonium Xylenesulfonate Coco Monoethanolamide Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) Sodium Benzoate Polyquaternium-10 (400 Cps At 2%) Polyethylene Glycol 7000 Dmdm Hydantoin Edetate Sodium Propylene Glycol Benzyl Alcohol Cucumber Cymbopogon Schoenanthus Leaf Mineral Oil Sodium 2-naphthalenesulfonate Methylchloroisothiazolinone Methylisothiazolinone Potassium Sorbate Fd&c Blue No. 1 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-02-17

Description

PYRITHIONE ZINC 1%

Purpose

ANTI-DANDRUFF


Medication Information

Purpose

ANTI-DANDRUFF

Description

PYRITHIONE ZINC 1%

Uses

FOR RELIEF OF FLAKING, AND ITCHING ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITIS AND TO HELP PREVENT THE CHANCE OF RE-OCCURENCE.

Warnings

FOR EXTERNAL USE ONLY.

Directions

APPLY SHAMPOO ON WET HAIR, RINSE THOROUGHLY. FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR.

Label Copy

Active Ingredient

PYRITHIONE ZINC 1%

Inactive Ingredients

WATER (AQUA), AMMONIUM LAURETH SULFATE, AMMONIUM LAURYL SULFATE, SODIUM CHLORIDE, GLYCOL DISTEARATE, DIMETHICONE, CITRIC ACID, SODIUM CITRATE, AMMONIUM XYLENESULFONATE, COCAMIDE MEA, FRAGRANCE (PARFUM), GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, SODIUM BENZOATE, POLYQUATERNIUM-10, PEG-7M, DMDM HYDANTOIN, TETRASODIUM EDTA, PROPYLENE GLYCOL, BENZYL ALCOHOL, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, CYMBOPOGON SCHOENANTHUS EXTRACT, MINERAL OIL, SODIUM POLYNAPHTHALENESULFONATE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, POTASSIUM SORBATE, BLUE 1 (CI 42090),  RED 33 (CI 17200).

Questions? Comments?

1-866-428-7327

When Using This Product

AVOID CONTACT WITH EYES. IF PRODUCT GETS INTO EYES, RINSE THOROUGHLY WITH WATER.

Keep Out of Reach of Children

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

Stop Using This Product and Ask A Doctor If

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


Structured Label Content

Uses (USES)

FOR RELIEF OF FLAKING, AND ITCHING ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITIS AND TO HELP PREVENT THE CHANCE OF RE-OCCURENCE.

Purpose (PURPOSE)

ANTI-DANDRUFF

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

Directions (DIRECTIONS)

APPLY SHAMPOO ON WET HAIR, RINSE THOROUGHLY. FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR.

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

PYRITHIONE ZINC 1%

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), AMMONIUM LAURETH SULFATE, AMMONIUM LAURYL SULFATE, SODIUM CHLORIDE, GLYCOL DISTEARATE, DIMETHICONE, CITRIC ACID, SODIUM CITRATE, AMMONIUM XYLENESULFONATE, COCAMIDE MEA, FRAGRANCE (PARFUM), GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, SODIUM BENZOATE, POLYQUATERNIUM-10, PEG-7M, DMDM HYDANTOIN, TETRASODIUM EDTA, PROPYLENE GLYCOL, BENZYL ALCOHOL, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, CYMBOPOGON SCHOENANTHUS EXTRACT, MINERAL OIL, SODIUM POLYNAPHTHALENESULFONATE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, POTASSIUM SORBATE, BLUE 1 (CI 42090),  RED 33 (CI 17200).

Questions? Comments? (QUESTIONS? COMMENTS?)

1-866-428-7327

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF PRODUCT GETS INTO EYES, RINSE THOROUGHLY WITH WATER.

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

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

Stop Using This Product and Ask A Doctor If (STOP USING THIS PRODUCT AND ASK A DOCTOR IF)

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


Advanced Ingredient Data


Raw Label Data

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