Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID d337e40d-a066-4bab-8da8-b53fca29962f
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 Cetostearyl Alcohol Behentrimonium Chloride Polyethylene Glycol 8000 Amodimethicone (1300 Cst) Cetyl Esters Wax Isopropyl Alcohol Methylparaben Hydroxyethyl Cellulose, Unspecified Menthol Trideceth-6 Benzyl Benzoate Propylene Glycol Benzyl Alcohol Benzyl Salicylate Chlorhexidine Hydrochloride .beta.-citronellol, (r)- Cetrimonium Chloride 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 50567-7

do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Section 51945-4

Warnings

For external use only

Directions
  • for best results use at least twice a week or as directed by a physician
  • wet hair and apply 1 - 2 ounces throughout entire head
  • massage gently into hair and scalp
  • cover hair with plastic cap and leave on for 3 minutes
  • rinse well
  • towel dry
  • style as desired
Active Ingredient

Pyrithione zinc 1%

Inactive Ingredients

water, cetearyl alcohol, behentrimonium chloride, glycerin, PEG-180, amodimethicone, cetyl esters, isopropyl alcohol, fragrance, methylparaben, hydroxyethylcellulose, menthol, trideceth-6, benzyl benzoate, propylene glycol, benzyl alcohol, sodium polynaphthalenesulfonate, benzyl salicylate, chlorhexidine dihydrochloride, citronellol, cetrimonium chloride, geraniol, mentha piperita (peppermint) oil, alpha-isomethyl ionone, cellulose gum, cucumis sativus (cucumber) fruit extract, methylisothiazolinone

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 worsens or does not improve after regular use


Structured Label Content

Use

helps eliminate recurrence of scalp flaking, scaling, and itching associated with dandruff

Section 50567-7 (50567-7)

do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

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
  • wet hair and apply 1 - 2 ounces throughout entire head
  • massage gently into hair and scalp
  • cover hair with plastic cap and leave on for 3 minutes
  • rinse well
  • towel dry
  • style as desired
Active Ingredient (Active ingredient)

Pyrithione zinc 1%

Inactive Ingredients (Inactive ingredients)

water, cetearyl alcohol, behentrimonium chloride, glycerin, PEG-180, amodimethicone, cetyl esters, isopropyl alcohol, fragrance, methylparaben, hydroxyethylcellulose, menthol, trideceth-6, benzyl benzoate, propylene glycol, benzyl alcohol, sodium polynaphthalenesulfonate, benzyl salicylate, chlorhexidine dihydrochloride, citronellol, cetrimonium chloride, geraniol, mentha piperita (peppermint) oil, alpha-isomethyl ionone, cellulose gum, cucumis sativus (cucumber) fruit extract, methylisothiazolinone

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 worsens or does not improve after regular use


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)