Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID bd281704-b411-4802-8dc6-8700d73fec9f
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 Cocamidopropyl Betaine Disodium Laureth Sulfosuccinate Sodium Lauryl Sulfoacetate Decyl Glucoside Sodium Lauroyl Sarcosinate Glycol Distearate Sodium Chloride Coco-betaine Amodimethicone (1300 Cst) Ppg-5-ceteth-20 Sodium Hydroxide Citric Acid Monohydrate Sodium Benzoate Carbomer 940 Propylene Glycol Polyquaternium-39 (22.5/51/26.5 Acrylic Acid/acrylamide/dadmac; 1600000 Mw) Menthol Hydrogenated Starch Hydrolysate Benzoic Acid Trideceth-6 Butylene Glycol .beta.-citronellol, (r)- Linalool, (+/-)- Limonene, (+)- Geraniol Cetrimonium Chloride Citral Carboxymethylcellulose Sodium (0.7 Carboxymethyl Substitution Per Saccharide; 150 Mpa.s At 1%) Edetate Sodium Aphanizomenon Flosaquae Azadirachta Indica Leaf Methylisothiazolinone Phenoxyethanol Potassium Sorbate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-01

Description

Pyrithone zinc 1%

Purpose

Antidandruff


Medication Information

Purpose

Antidandruff

Description

Pyrithone zinc 1%

Use

helpls 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
  • apply to wet hair by gently massaging onto scalp and hair
  • rinse well
Active Ingredient

Pyrithone zinc 1%

Inactive Ingredients

water, cocamidopropyl betaine, disodium laureth sulfosuccinate, sodium lauryl sulfoacetate, decyl glucoside, sodium lauroyl sarcosinate, glycol distearate, sodium chloride, coco-betaine, fragrance, amodimethicone, PPG-5-ceteth-20, acrylates copolymer, sodium benzoate, carbomer, PEG-55 propylene glycol oleate, propylene glycol, polyquaternium-39, menthol, hydrogenated starch hydrolysate, benzoic acid, trideceth-6, butylene glycol, citronellol, sodium polynaphthalenesulfonate, linalool, limonene, geraniol, cetrimonium chloride, citral, cellulose gum, tetrasodum EDTA, aphanizomenon flos-aquae extract, melia azadirachta leaf extract, methylisothiazolinone, phenoxyethanol, potassium sorbate

Questions Or Comments?

1-800-631-7358

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

helpls prevent recurrence of scalp flaking 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 doctor
  • apply to wet hair by gently massaging onto scalp and hair
  • rinse well
Active Ingredient (Active ingredient)

Pyrithone zinc 1%

Inactive Ingredients (Inactive ingredients)

water, cocamidopropyl betaine, disodium laureth sulfosuccinate, sodium lauryl sulfoacetate, decyl glucoside, sodium lauroyl sarcosinate, glycol distearate, sodium chloride, coco-betaine, fragrance, amodimethicone, PPG-5-ceteth-20, acrylates copolymer, sodium benzoate, carbomer, PEG-55 propylene glycol oleate, propylene glycol, polyquaternium-39, menthol, hydrogenated starch hydrolysate, benzoic acid, trideceth-6, butylene glycol, citronellol, sodium polynaphthalenesulfonate, linalool, limonene, geraniol, cetrimonium chloride, citral, cellulose gum, tetrasodum EDTA, aphanizomenon flos-aquae extract, melia azadirachta leaf extract, methylisothiazolinone, phenoxyethanol, potassium sorbate

Questions Or Comments? (Questions or comments?)

1-800-631-7358

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

All Sections (JSON)