Medication info

Winlevi Cream (Clascoterone)

Prescription medicationCream
Ingredient · strength
Clascoterone›10mg / 1g
Manufacturer / importer
현대약품(주)
Appearance
A homogeneous cream that is white or almost white
Packaging
30 grams/tube
Approval status
Active

MFDS item code 202502573 · Approved 2025.09.29

Summary

Main use
Improvement of moderate to severe acne vulgaris
Who uses it
Adults
Adult dosage
Clean and dry the affected skin, and apply a thin, even layer of the cream twice daily, in the morning and evening. The recommended single application amount is about 1g maximum.

Ingredients

Importer
현대약품(주)

Efficacy & effects

Improvement of moderate to severe acne vulgaris

  • Moderate to severe acne vulgaris
View approved original text

This medication is used for the treatment of moderate to severe acne vulgaris occurring in patients over 12 years of age. It is applied directly to the skin to improve acne, reduce inflammation, and help normalize skin conditions. Regular use can be expected to yield results.

Dosage and Administration

Adult dosage

Clean and dry the affected skin, and apply a thin, even layer of the cream twice daily, in the morning and evening. The recommended single application amount is about 1g maximum.

Precautions

This medication must only be used as a topical agent applied to the skin. Do not use if you have had allergies or hypersensitivity to this medication or any of its ingredients. Do not apply to damaged skin, such as wounds, abrasions, eczema, or burns. Take care to avoid contact with mucous membranes such as the eyes, mouth, and nose, and if contact occurs, wash thoroughly with clean water immediately. Pregnant women must consult a doctor before using this medication. This product contains propylene glycol; individuals with allergies or hypersensitivity to this ingredient should use it with caution. Local irritation symptoms such as redness, itching, swelling, dryness, or stinging may occur during the use of this medication. Using this medication over large areas for extended periods or in conjunction with other corticosteroid preparations may increase systemic absorption, so caution is advised. Particularly, children may be more sensitive to systemic toxicity, requiring careful use. Using this medication may lead to hypothalamic-pituitary-adrenal (HPA) axis suppression; if symptoms arise, discontinue use and consult a healthcare provider. It is advisable not to use with other topical medications or irritating cosmetics, soaps, etc. Studies on drug interactions with this medication are limited, so if you are taking other medications, consult a doctor or pharmacist. Pregnant or breastfeeding women must consult a specialist prior to use, as safety has not been adequately established. Safety and efficacy have not been established for children under 12 years of age, and use is not recommended. There is also insufficient data on the safety and efficacy of this medication for elderly patients over 65 years, so caution is advised. After applying this medication, wash your hands thoroughly to avoid contact with other areas. Unused medication should be stored at room temperature below 25 degrees Celsius, should not be frozen, and should be used within 1 month after opening. Store out of reach of children to prevent accidental ingestion.

Side effects and when to seek care immediately

Serious side effects

Hypothalamic-pituitary-adrenal (HPA) axis suppression

Mild side effects

  • Erythema/Redness
  • scaling/dry skin
  • itching
  • stinging/burning sensation
  • swelling
  • redness of stretch marks
  • skin atrophy
  • telangiectasia
  • hyperkalemia
  • polycystic ovaries
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  • amenorrhea

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to light and must be stored in a container that protects it from light. Additionally, to maintain freshness, it should be stored in a refrigerator at a temperature between 2 to 8 degrees Celsius. Storing it this way helps to prolong the effectiveness of the medication.

Appearance and packaging

Appearance

A homogeneous cream that is white or almost white

Package unit

30 grams/tube

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.