Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 422e743b-fd77-40ed-8c5d-7f05112a447f
Route
TOPICAL
Published
Effective Date 2025-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (10 mg)
Inactive Ingredients
Water Sodium C14 Olefin Sulfonate Disodium Cocoamphodiacetate Sodium Chloride Glycol Distearate Amodimethicone (1300 Cst) Triethyl Citrate Sodium Lauryl Sulfoacetate Ppg-5-ceteth-20 Sodium Hydrolyzed Potato Starch Dodecenylsuccinate Cocamide Mipa Ceramide Np Ceramide Ap Carbomer Niacinamide Trideceth-6 Sodium Hydroxide Sodium Benzoate Sodium Lauroyl Lactylate Salicylic Acid Sodium Hyaluronate Cholesterol Phenoxyethanol Coco-betaine Propylene Glycol Citric Acid Cetrimonium Chloride Caprylyl Glycol Xanthan Gum 3-phytase A (aspergillis Niger) Polyquaternium-10 (1000 Mpa.s At 2%) Acrylamidopropyltrimonium Chloride/acrylamide Copolymer (400 Mpa.s)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-11

Description

Pyrithione zinc 1%

Purpose

Anti-dandruff


Medication Information

Purpose

Anti-dandruff

Description

Pyrithione zinc 1%

Use

helps prevent recurrence of scalp flaking 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 doctor
  • wet hair and massage onto scalp
  • rinse and repeat if desired
Active Ingredient

Pyrithione zinc 1%

Inactive Ingredients

water, sodium C14-16 olefin sulfonate, disodium laureth sulfosuccinate, disodium cocoamphodiacetate, sodium chloride, glycol distearate, amodimethicone, sodium lauryl sulfoacetate, PPG-5-ceteth-20, potato starch modified, cocamide MIPA, ceramide NP, ceramide AP, ceramide EOP, carbomer, niacinamide, trideceth-6, triethyl citrate, sodium hydroxide, sodium benzoate, sodium lauroyl lactylate, salicylic acid, sodium polynaphthalenesulfonate, sodium hyaluronate, cholesterol, phenoxyethanol, coco-betaine, propylene glycol, citric acid, cetrimonium chloride, caprylyl glycol, xanthan gum, phytosphingosine, polyquaternium-10, acrylates copolymer, benzoic acid

Questions Or Comments?

Toll-free number 1-888-768-2915

When Using This Product

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

Stop Use and Ask A Doctor If

conditions worsens or does not improve 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 right away.


Structured Label Content

Use

helps prevent recurrence of scalp flaking and itching associated with dandruff

Section 51945-4 (51945-4)

Purpose

Anti-dandruff

Warnings

For external use only

Directions
  • for best results use at least twice a week or as directed by a doctor
  • wet hair and massage onto scalp
  • rinse and repeat if desired
Active Ingredient (Active ingredient)

Pyrithione zinc 1%

Inactive Ingredients (Inactive ingredients)

water, sodium C14-16 olefin sulfonate, disodium laureth sulfosuccinate, disodium cocoamphodiacetate, sodium chloride, glycol distearate, amodimethicone, sodium lauryl sulfoacetate, PPG-5-ceteth-20, potato starch modified, cocamide MIPA, ceramide NP, ceramide AP, ceramide EOP, carbomer, niacinamide, trideceth-6, triethyl citrate, sodium hydroxide, sodium benzoate, sodium lauroyl lactylate, salicylic acid, sodium polynaphthalenesulfonate, sodium hyaluronate, cholesterol, phenoxyethanol, coco-betaine, propylene glycol, citric acid, cetrimonium chloride, caprylyl glycol, xanthan gum, phytosphingosine, polyquaternium-10, acrylates copolymer, benzoic acid

Questions Or Comments? (Questions or Comments?)

Toll-free number 1-888-768-2915

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)

conditions worsens or does not improve 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 right away.


Advanced Ingredient Data


Raw Label Data

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