Indication and Use
Wynzora® (calcipotriene and betamethasone dipropionate) Cream is indicated for plaque
psoriasis in adults. It is not known if Wynzora Cream is safe and effective in
Important Safety Information
- Wynzora Cream is for topical use only.
- Patients should not use more than 100g of Wynzora Cream per week.
- Wynzora Cream should not be used near or in the mouth, eyes, or intravaginally.
- Patients should avoid using Wynzora Cream on the face, groin, or armpits, or if
they have atrophy at the treatment site.
- Patients should apply Wynzora Cream to the affected areas of the skin once a day
for up to 8 weeks.
- Patients should discontinue use once the plaque psoriasis is under control.
- Patients should not use with occlusive dressings.
- Hypercalcemia and hypercalciuria have been observed with use of topical
- Wynzora Cream can cause reversible HPA axis suppression with the potential for
clinical glucocorticosteroid insufficiency during and after withdrawal of treatment.
- Wynzora Cream may cause vision problems, including increasing the risk of
cataracts and glaucoma.
- It is not known whether Wynzora Cream may harm your unborn baby.
- Breastfeeding women should not apply Wynzora Cream directly to the nipple and
- It is not known whether topically administered calcipotriene and betamethasone
dipropionate is absorbed in human milk.
Please see Full Prescribing Information for
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
References: 1. Wynzora® Cream [package insert]. MC2 Therapeutics; 2020. 2. Præstegaard M, Vestbjerg B, Selmer J, Holm-Larsen T. Phase 3 trial demonstrates superior patient treatment convenience of MC2-01 calcipotriene plus betamethasone dipropionate cream compared to current topical suspension. J of Skin. 2020;4(5):s62.3. US Department of Health and Human Services. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. 41st ed. US Government Publishing Office; 2021. https://www.fda.gov/media/71474/download. Accessed June 24, 2021. 4. Data on file. MC2 Therapeutics.