SPL v2
SPL
SPL Set ID 33b17b18-2f2b-4f6a-9d01-d4c81dd5186a
Route
TOPICAL
Published
Effective Date 2010-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (.01 g)
Inactive Ingredients
Water Sodium Laureth Sulfate Sodium Lauryl Sulfate Coco Monoethanolamide Cocamidopropyl Betaine Dimethicone Cocoa Butter Laureth-4 Laureth-7 Sodium Chloride Citric Acid Sodium Hydroxide Almond Oil Olive Oil Equisetum Arvense Top Larrea Tridentata Top Tussilago Farfara Horse Chestnut Filipendula Ulmaria Flower Red Clover Methylchloroisothiazolinone Methylisothiazolinone Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2008-04-20
Description

Active Ingredient Pyrithione Zinc  1%

Medication Information

Warnings and Precautions

Warnings -       For external use only

Indications and Usage

Use - helps prevent recurrence of flaking and itching associated with dandruff.

Dosage and Administration

Directions:

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

Description

Active Ingredient Pyrithione Zinc  1%

Section 50565-1
Keep 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

  • if condition worsens or does not improve after regular use as directed.



Section 50567-7
When using this product



  • do not get into eyes.  If contact occurs, rinse eyes thoroughly with water.

Section 51727-6

Inactive Ingredients:   Aqua (Water), Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Cocamide MEA, Coco Glucoside, Acrylates Copolymer, Cocamidopropyl Betaine, Fragrance (Parfum), Sodium Hydroxide, Olea Europaea (Olive) Fruit Oil, Olea Europaea (Olive) Leaf Extract, Herbal Extract Blend:  Equisetum Arvense (Horsetail) Leaf Extract, Larrea Divaricata (Chaparral) Extract, Tussilago Farfara (Coltsfoot) Flower Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Spiraea Ulmaria (Meadowsweet) Flower Extract, Trifolium Pratense (Clover) Flower Extract, PEG-8 Amodimethicone, Methylchloroisothiazolinone/Methylisothiazolinone, Blue #1 (CI 42090), Yellow #5 (CI 19140).

Section 51945-4




Section 55105-1
Purpose

Anti-dandruff
Section 55106-9
Active Ingredient



Pyrithione Zinc  1%

Structured Label Content

Indications and Usage (34067-9)

Use - helps prevent recurrence of flaking and itching associated with dandruff.

Dosage and Administration (34068-7)

Directions:

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

Warnings and Precautions (34071-1)

Warnings -       For external use only

Section 50565-1 (50565-1)
Keep 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

  • if condition worsens or does not improve after regular use as directed.



Section 50567-7 (50567-7)
When using this product



  • do not get into eyes.  If contact occurs, rinse eyes thoroughly with water.

Section 51727-6 (51727-6)

Inactive Ingredients:   Aqua (Water), Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Cocamide MEA, Coco Glucoside, Acrylates Copolymer, Cocamidopropyl Betaine, Fragrance (Parfum), Sodium Hydroxide, Olea Europaea (Olive) Fruit Oil, Olea Europaea (Olive) Leaf Extract, Herbal Extract Blend:  Equisetum Arvense (Horsetail) Leaf Extract, Larrea Divaricata (Chaparral) Extract, Tussilago Farfara (Coltsfoot) Flower Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Spiraea Ulmaria (Meadowsweet) Flower Extract, Trifolium Pratense (Clover) Flower Extract, PEG-8 Amodimethicone, Methylchloroisothiazolinone/Methylisothiazolinone, Blue #1 (CI 42090), Yellow #5 (CI 19140).

Section 51945-4 (51945-4)




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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:08.608394 · Updated: 2026-03-14T22:52:29.225907