Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID 482e11db-c886-4ad3-b378-0839a0715ea7
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 Coco-betaine Glycol Distearate Dimethicone Sodium Chloride Glycerin Disodium Cocoamphodiacetate Sodium Benzoate Sodium Hydroxide Citric Acid Monohydrate Polyquaternium-10 (1000 Mpa.s At 2%) Methylparaben Coco Monoisopropanolamide Carbomer Homopolymer, Unspecified Type Salicylic Acid Menthol Ethylparaben Benzyl Benzoate Propylene Glycol Benzyl Alcohol Benzyl Salicylate .beta.-citronellol, (r)- Geraniol Peppermint Oil Isomethyl-.alpha.-ionone Carboxymethylcellulose Sodium, Unspecified Cucumber Methylisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2008-06-01

Description

Pyrithione zinc 1%

Purpose

Antidandruff


Medication Information

Purpose

Antidandruff

Description

Pyrithione zinc 1%

Use

helps eliminate recurrence of scalp flaking, scaling, and itching 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

• wet hair and apply 1 - 2 ounces throughout entire head

• massage vigorously

• leave on scalp 1 to 3 minutes

• rinse well

• repeat if necessary

Active Ingredient

Pyrithione zinc 1%

Inactive Ingredients

water, sodium laureth sulfate, sodium lauryl sulfate, coco-betaine, glycol distearate, dimethicone, sodium chloride, glycerin, disodium cocoamphodiacetate, fragrance, sodium benzoate, sodium hydroxide, citric acid, polyquaternium-10, methylparaben, cocamide MIPA, carbomer, salicylic acid, menthol, ethylparaben, benzyl benzoate, propylene glycol, benzyl alcohol, sodium polynaphthalenesulfonate, benzyl salicylate, citronellol, geraniol, mentha piperita (peppermint) oil, alpha-isomethyl ionone, cellulose gum, cucumis sativus (cucumber) fruit extract, methylisothiazolinone

When Using This Product

do not getinto 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 Consult A Physician If

condition worsents or does not improve after regular use


Structured Label Content

Use

helps eliminate recurrence of scalp flaking, scaling, and itching 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

• wet hair and apply 1 - 2 ounces throughout entire head

• massage vigorously

• leave on scalp 1 to 3 minutes

• rinse well

• repeat if necessary

Active Ingredient (Active ingredient)

Pyrithione zinc 1%

Inactive Ingredients (Inactive ingredients)

water, sodium laureth sulfate, sodium lauryl sulfate, coco-betaine, glycol distearate, dimethicone, sodium chloride, glycerin, disodium cocoamphodiacetate, fragrance, sodium benzoate, sodium hydroxide, citric acid, polyquaternium-10, methylparaben, cocamide MIPA, carbomer, salicylic acid, menthol, ethylparaben, benzyl benzoate, propylene glycol, benzyl alcohol, sodium polynaphthalenesulfonate, benzyl salicylate, citronellol, geraniol, mentha piperita (peppermint) oil, alpha-isomethyl ionone, cellulose gum, cucumis sativus (cucumber) fruit extract, methylisothiazolinone

When Using This Product (When using this product)

do not getinto 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 Consult A Physician If (Stop use and consult a physician if)

condition worsents or does not improve after regular use


Advanced Ingredient Data


Raw Label Data

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