FDA label
What is pimecrolimus used for?
The FDA-approved uses of pimecrolimus, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable.”
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Pimecrolimus, cream
Indications and Usage, quoted from the label by Glenmark Pharmaceuticals Inc., USA (ANDA211769). Cross-references to other label sections are left out.
Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable.
Pimecrolimus cream, 1% is not indicated for use in children less than 2 years of age.
Source: DailyMed label, set id ac52a235-1b6f-47a2-b3d9-8d538eeae02f, version 3, effective October 28, 2025. NDC 68462-609, one of 2 listings for this product.
Questions
What is pimecrolimus used for?
The FDA label says: “Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable.”
What drug class is pimecrolimus?
FDA lists pimecrolimus in the Calcineurin Inhibitor Immunosuppressant established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.