WINLEVI® (clascoterone) cream 1% 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.

WHAT IS WINLEVI®?

Know your

 

WINLEVI is the only acne cream that targets sebum (oil) production,

leading to clearer skin and more control over future breakouts.

What is SEBUM?

Sebum is an oily wax that your skin makes. Some of it’s good—it keeps your skin hydrated and protected. But when there’s too much, it becomes acne’s best friend, feeding the bacteria that cause breakouts.

All acne is hormonal

Acne hormones in your skin drive sebum production. So when hormone triggers like stress, puberty, or your menstrual cycle stir things up, your skin produces more sebum, causing acne breakouts.

WINLEVI is unique

Unlike any other topical, WINLEVI reduces sebum production by stopping those acne hormones in your skin from causing too much sebum—leading to clearer skin and more control over acne breakouts.

Unlike over-the-counter acne products, WINLEVI is an FDA-approved prescription treatment—with safety shown in males and females ages 12 and up.

Important Safety Information

The most common side effects of WINLEVI cream include reddening, scaling or dryness, and itching of the skin being treated. Please see more Important Safety Information below.

Acne control + moisturization with WINLEVI

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Some acne medications can be drying, but WINLEVI moisturizes while controlling acne.

WINLEVI doesn’t damage your skin barrier, helping your skin to stay hydrated when used twice daily.

See how to apply WINLEVI as part of your normal skincare routine.

What makes WINLEVI different?
Dr. Pimple Popper has the answers.

Welcome to WINLEVI! 

Let’s focus on how WINLEVI is different from other acne creams.

WINLEVI (clascoterone) cream 1% is a topical androgen inhibitor, and this targets the acne hormones in your skin. So, what does this mean?

This is a pore in your skin and here’s a sebaceous gland. Acne hormones known as androgens, they start the acne chain reaction by stimulating the sebaceous gland.Androgen levels fluctuate throughout our lifetimes, and this is perfectly normal.

Androgens tell the sebaceous gland to make sebum, which is an oily wax. When androgen levels increase, such as during puberty, this can lead to excess sebum.

Sebum acts as food for bacteria, so this extra sebum can cause bacteria to grow, leading to inflammation and contributing to clogged pores.

When you have all of these factors working together… Pop! We’ve got an acne breakout.

WINLEVI is an FDA-approved prescription cream that breaks this chain reaction at the hormone level before it starts.

WINLEVI is the only topical that reduces the effects of the acne hormones, androgens, in your skin. By targeting androgens, which is a root cause of acne, your skin may produce less sebum. Less sebum may mean less acne.

WINLEVI is FDA-approved for all acne patients, both females and males, aged 12 and older. The most common side effects of WINLEVI cream include reddening, scaling or dryness, and itchiness of the skin being treated. These are not all possible effects of WINLEVI cream.

Be sure to visit your dermatologist to see if WINLEVI is appropriate for you.

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Important Patient Information

Before using WINLEVI cream, tell your healthcare provider about all of your medical conditions, particularly 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

Important Safety Information

Indication

What is WINLEVI® cream?

WINLEVI (clascoterone) cream 1% 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.

Important Patient Information

Before using WINLEVI cream, tell your healthcare provider about all of your medical conditions, particularly 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

WINLEVI cream is for use on the skin only (topical). Do not use WINLEVI cream in or on your eyes, mouth, or vagina. 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.

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 cream include reddening, scaling or dryness, and itching of the skin being treated.
These are not all of the possible side effects of WINLEVI cream.

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

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or to Sun Pharmaceutical Industries, Inc. by calling 1-800-818-4555.

Please see full Prescribing Information and the Patient Information.

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