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Winlevi (Clascoterone): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
1 g/100 g
Drug class:
Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Winlevi

What is WINLEVI cream?

WINLEVI cream is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years of age and older.

It is not known if WINLEVI cream is safe and effective in children under 12 years of age.

  • Before using WINLEVI cream, tell your healthcare provider about all of your medical conditions, including if you:
  • have skin problems, including eczema, cuts or sunburn

  • are pregnant or plan to become pregnant. It is not known if WINLEVI cream will harm your unborn baby.

  • are breastfeeding or plan to breastfeed. It is not known if WINLEVI cream passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with WINLEVI cream.

Tell your healthcare provider about the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use WINLEVI cream?

  • Use WINLEVI cream exactly as your healthcare provider tells you to use it.
  • Before applying WINLEVI cream, gently wash and dry the affected skin area.
  • After the skin is dry, apply a thin even layer of WINLEVI cream to the affected areas 2 times each day, in the morning and the evening.
  • Wash your hands after applying WINLEVI cream.

What should I avoid while using WINLEVI cream?

  • Avoid using WINLEVI cream on skin areas with cuts, abrasions, eczema, or on sunburned skin.
  • Avoid getting WINLEVI cream into your eyes, lips, mouth, corners of the nose, or mucous membranes. If contact with mucous membranes happens, rinse well with water.

  • Avoid using skin products that may dry or irritate your skin such as:

    • medicated or abrasive soaps and cleansers
    • soaps, cleansers, and cosmetics that have strong skin drying effects
    • products that contain high amounts of alcohol
    • astringents, spices, or lime

What are the possible side effects of WINLEVI cream?

WINLEVI cream can cause serious side effects, including:

  • Local skin reactions.WINLEVI cream may cause local skin irritation including itching, burning, skin redness or peeling.
  • Symptoms of a disorder where the adrenal gland does not make enough of certain hormones (adrenal insufficiency) during treatment with WINLEVI.Your healthcare provider may stop your treatment with WINLEVI if you develop any adrenal problems.

The most common side effects of WINLEVI creaminclude reddening, scaling or dryness, and itching of the skin being treated.

These are not all of the possible side effects of WINLEVI cream.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Sun Pharmaceutical Industries, Inc. by calling 1-800-818-4555.

How should I store WINLEVI cream?

  • Store WINLEVI cream at room temperature between 68°F and 77°F (20°C to 25°C). Do not freeze.
  • Throw away (discard) the unused portion 180 days after the date of dispensing or 1 month after first opening, whichever is sooner.

Keep WINLEVI cream and all medicines out of the reach of children.

General Information about the safe and effective use of WINLEVI cream.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use WINLEVI cream for a condition for which it was not prescribed. Do not give WINLEVI cream to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about WINLEVI cream that is written for health professionals.

What are the ingredients in WINLEVI cream?

Active ingredient:clascoterone

Inactive ingredients:cetyl alcohol, citric acid monohydrate, edetate disodium, mineral oil, mono- and di-glycerides, polysorbate 80, propylene glycol, purified water, and vitamin E.

Manufactured in Italy for: Sun Pharmaceutical Industries Limited

Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512

WINLEVI is a licensed trademark of Cassiopea, S.p.A. exclusively licensed by Sun Pharmaceutical Industries, Ltd.

US Patents: https://www.cassiopea.com/patents

©2022 Sun Pharmaceutical Industries Limited, All right reserved.

This Patient Information has been approved by the U.S. Food and Drug Administration

Issued: 07/2022

2000405-3

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 213433 · View the label on DailyMed

Revision date stated in the text: July 2022

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Winlevi

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Androgen Receptor Inhibitor
Active ingredient Clascoterone 1 g/100 g
Dosage form Cream
Route Topical
Marketing status listed in the FDA NDC Directory
Company (applicant) SUN PHARM
FDA approval NDA 213433New Drug Application (NDA) Approved August 26, 2020
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
1 g/100 g – 60 g in 1 tube / 1 in 1 carton NDC 47335-994-36
1 g/100 g – 2 g in 1 tube / 1 in 1 carton / 12 in 1 case NDC 47335-994-40

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.