Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID 306a1ef4-e7ed-4c8c-877c-3c34d3e6d7b7
Route
TOPICAL
Published
Effective Date 2023-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (10 mg)
Inactive Ingredients
Water Sodium Laureth Sulfate Sodium Lauryl Sulfate Glycerin Coco Monoethanolamide Glycol Distearate Sodium Chloride Hexylene Glycol Dimethicone Citric Acid Monohydrate Sodium Benzoate Sodium Hydroxide Coco-betaine Carbomer Homopolymer, Unspecified Type Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) 3-((l-menthyl)oxy)propane-1,2-diol Salicylic Acid Hydrolyzed Soy Protein (enzymatic; 2000 Mw) Eugenol Limonene, (+)- Carboxymethylcellulose Sodium, Unspecified Egg Phospholipids Fumaric Acid Phosphoric Acid Lavender Oil Methylisothiazolinone Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2006-08-17 Until 2021-12-30

Description

Pyrithione zinc 1%

Purpose

Antidandruff


Medication Information

Purpose

Antidandruff

Description

Pyrithione zinc 1%

Uses
  • for the relief of the symptoms of dandruff
  • helps prevent recurrence of the symptoms of dandruff
  • controls scalp itching, irritation, redness, flaking and scaling associated with dandruff
Section 51945-4

Warnings

For external use only

Directions
  • for best results use at least twice a week or as directed by a physician
  • shake well before each use
  • apply to wet or dry hair, massaging into scalp
  • leave on 5 minutes
  • wet hair, lather and rinse
  • can be used daily
Active Ingredient

Pyrithione zinc 1%

Inactive Ingredients

water, sodium laureth sulfate, sodium lauryl sulfate, glycerin, cocamide MEA, glycol distearate, sodium chloride, hexylene glycol, dimethicone, citric acid, fragrance, sodium benzoate, sodium hydroxide, coco-betaine, carbomer, guar hydroxypropyltrimonium chloride, menthoxypropanediol, sodium polynaphthalenesulfonate, salicylic acid, hydrolyzed soy protein, eugenol, limonene, cellulose gum, lecithin, fumaric acid, phosphoric acid, lavandula angustifolia (lavender) oil, methylisothiazolinone, tocopherol

When Using This Product

avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Keep Out of Reach of Children.

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

Stop Use and Ask A Physician If

condition worsens or does not improve after regular use


Structured Label Content

Uses
  • for the relief of the symptoms of dandruff
  • helps prevent recurrence of the symptoms of dandruff
  • controls scalp itching, irritation, redness, flaking and scaling associated with dandruff
Section 51945-4 (51945-4)

Purpose

Antidandruff

Warnings

For external use only

Directions
  • for best results use at least twice a week or as directed by a physician
  • shake well before each use
  • apply to wet or dry hair, massaging into scalp
  • leave on 5 minutes
  • wet hair, lather and rinse
  • can be used daily
Active Ingredient (Active ingredient)

Pyrithione zinc 1%

Inactive Ingredients (Inactive ingredients)

water, sodium laureth sulfate, sodium lauryl sulfate, glycerin, cocamide MEA, glycol distearate, sodium chloride, hexylene glycol, dimethicone, citric acid, fragrance, sodium benzoate, sodium hydroxide, coco-betaine, carbomer, guar hydroxypropyltrimonium chloride, menthoxypropanediol, sodium polynaphthalenesulfonate, salicylic acid, hydrolyzed soy protein, eugenol, limonene, cellulose gum, lecithin, fumaric acid, phosphoric acid, lavandula angustifolia (lavender) oil, methylisothiazolinone, tocopherol

When Using This Product (When using this product)

avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

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

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

Stop Use and Ask A Physician If (Stop use and ask a physician if)

condition worsens or does not improve after regular use


Advanced Ingredient Data


Raw Label Data

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