Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 8a7b4626-d76b-45c4-b7a3-33c91e9a0bfe
Route
TOPICAL
Published
Effective Date 2025-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (10 mg)
Inactive Ingredients
Water Sodium C14-16 Olefin Sulfonate Disodium Laureth Sulfosuccinate Disodium Cocoamphodiacetate Sodium Chloride Glycol Distearate Amodimethicone (1300 Cst) Sodium Lauryl Sulfoacetate Ppg-5-ceteth-20 Cocamide Mipa Sodium Hydrolyzed Potato Starch Dodecenylsuccinate Ceramide Np Ceramide Ap Carbomer Niacinamide Trideceth-6 Triethyl Citrate Sodium Hydride Sodium Benzoate Sodium Lauroyl Lactylate Salicylic Acid Sodium Hyaluronate Cholesterol Phenoxyethanol Propylene Glycol Coco-betaine Citric Acid Tetrasodium Glutamate Diacetate Cetrimonium Chloride Caprylyl Glycol Xanthan Gum Phytosphingosine Polyquaternium-10 (10000 Mpa.s At 2%) Benzoic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01

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 lease 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,c ocamide MIPA, potato starch modified, 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,p ropylene glycol , citric acid, tetrasodium glutamate diacetate, cetrimonium chloride, caprylyl glycol, xanthan gum, phytosphingosine, polyquaternium-10, acrylates copolymer, benzoic acid

Question 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 condition 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 lease 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

water, sodium C14-16 olefin sulfonate, disodium laureth sulfosuccinate, disodium cocoamphodiacetate,sodium chloride, glycol distearate, amodimethicone, sodium lauryl sulfoacetate, PPG-5-ceteth-20,c ocamide MIPA, potato starch modified, 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,p ropylene glycol , citric acid, tetrasodium glutamate diacetate, cetrimonium chloride, caprylyl glycol, xanthan gum, phytosphingosine, polyquaternium-10, acrylates copolymer, benzoic acid

Question Or Comments? (Question 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 (Stop use and ask a doctor)

If condition 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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