Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 8564f2cf-b680-4e2c-8451-f345c9852c1a
Route
TOPICAL
Published
Effective Date 2024-07-18
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 Menthol Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) Limonene, (+)- Salicylic Acid .alpha.-hexylcinnamaldehyde Coumarin Benzyl Alcohol Linalool, (+/-)- .alpha.-amylcinnamaldehyde Pentylene Glycol Mentha X Piperita Whole Carboxymethylcellulose Sodium, Unspecified Fumaric Acid Methylisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-05-01

Description

Pyrithione zinc 1%

Purpose

Antidandruff


Medication Information

Purpose

Antidandruff

Description

Pyrithione zinc 1%

Use

fights scalp scaling, itching and flaking due to 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; apply evenly onto scalp

- leave on 1 - 3 minutes; rinse

- repeat if necessary

Active Ingredient

Pyrithione zinc 1%

Inactive Ingredients

water, sodium laureth sulfate, sodium lauryl sulfate, glycerin, cocamide MEA, glycol distearate, sodium chloride, hexylene glycol, dimethicone, fragrance, citric acid, sodium benzoate, sodium hydroxide, coco-betaine, carbomer, menthol, guar hydroxypropyltrimonium chloride, limonene, sodium polynaphthalenesulfonate, salicylic acid, hexyl cinnamal, coumarin, benzyl alcohol, linalool, amyl cinnamal, pentylene glycol, mentha piperita (peppermint) extract, cellulose gum, fumaric acid, methylisothiazolinone

When Using This Product

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

Stop Use and Ask A Doctor If

condition worsens or does not improve after regular use

Keep Out of Reach of Children.

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


Structured Label Content

Use

fights scalp scaling, itching and flaking due to 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; apply evenly onto scalp

- leave on 1 - 3 minutes; rinse

- repeat if necessary

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, fragrance, citric acid, sodium benzoate, sodium hydroxide, coco-betaine, carbomer, menthol, guar hydroxypropyltrimonium chloride, limonene, sodium polynaphthalenesulfonate, salicylic acid, hexyl cinnamal, coumarin, benzyl alcohol, linalool, amyl cinnamal, pentylene glycol, mentha piperita (peppermint) extract, cellulose gum, fumaric acid, methylisothiazolinone

When Using This Product (When using this product)

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

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.


Advanced Ingredient Data


Raw Label Data

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