1398 Antidandruff Shampoo Ndc 67777-139-80

1398 Antidandruff Shampoo Ndc 67777-139-80
SPL v8
SPL
SPL Set ID 7fad58a3-5537-f87a-e053-2991aa0a7cdb
Route
TOPICAL
Published
Effective Date 2018-10-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (5 g)
Inactive Ingredients
Glycol Distearate Glyceryl Monooleate Polyquaternium-10 (1000 Mpa.s At 2%) Triethanolamine Dodecylbenzenesulfonate Benzyl Alcohol Methylchloroisothiazolinone Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Sodium Laureth Sulfate Coco Monoethanolamide Sodium Chloride Methylisothiazolinone .alpha.-amylcinnamaldehyde Water Styrene/acrylamide Copolymer (mw 500000) Dimethiconol (2000 Cst) Citric Acid Monohydrate Sodium Benzoate Salicylic Acid Sodium Hydroxide Fd&c Blue No. 1 Cocamidopropyl Betaine Coco Glucoside

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-10-11
Description

Pyrithione Zinc 0.5%

Purpose

Anti-Dandruff

Medication Information

Purpose

Anti-Dandruff

Description

Pyrithione Zinc 0.5%

Use

Helps eliminate irritation and flaking associated with dandruff

Label

Dandruff Shampoo

Warnings

For External Use Only

Directions
  • wet hair
  • lather
  • massage onto scalp
  • rinse well
  • repeat if desired
  • for best results, use regularly
Active Ingredient

Pyrithione Zinc 0.5%

Inactive Ingredients

Acrylates Copolymer, Amyl Cinnamal, Benzyl Alcohol, Benzyl Salicylate, CI 42090, Citric Acid, Cocamide MEA, Cocamidopropyl Betaine, Coco-Glucoside, Dimethiconol, Glyceryl Oleate, Glycol Distearate, Methylchloroisothiazolinone, Methylisothiazolinone, Perfume, Polyquaternium-10, Sodium Benzoate, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Styrene/Acrylamide Copolymer, TEA-Dodecylbenzenesulfonate, Water

When Using This Product
  • Avoid contact with eyes
  • If contact occurs, rinse eyes with plenty of water
Stop Use and Ask A Doctor If

condition does not improve or worsens after regular use of this product as directed.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately.

Structured Label Content

Use

Helps eliminate irritation and flaking associated with dandruff

Label

Dandruff Shampoo

Purpose

Anti-Dandruff

Warnings

For External Use Only

Directions
  • wet hair
  • lather
  • massage onto scalp
  • rinse well
  • repeat if desired
  • for best results, use regularly
Active Ingredient (Active ingredient)

Pyrithione Zinc 0.5%

Inactive Ingredients (Inactive ingredients)

Acrylates Copolymer, Amyl Cinnamal, Benzyl Alcohol, Benzyl Salicylate, CI 42090, Citric Acid, Cocamide MEA, Cocamidopropyl Betaine, Coco-Glucoside, Dimethiconol, Glyceryl Oleate, Glycol Distearate, Methylchloroisothiazolinone, Methylisothiazolinone, Perfume, Polyquaternium-10, Sodium Benzoate, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Styrene/Acrylamide Copolymer, TEA-Dodecylbenzenesulfonate, Water

When Using This Product (When using this product)
  • Avoid contact with eyes
  • If contact occurs, rinse eyes with plenty of water
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition does not improve or worsens after regular use of this product as directed.

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center immediately.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:27.194619 · Updated: 2026-03-14T23:12:39.597935