FDA label
What is terconazole used for?
The FDA-approved uses of terconazole, 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: “Terconazole vaginal cream 0.4% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 0.4% is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.”
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Terconazole, cream
Indications and Usage, quoted from the label by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC (ANDA076712). Cross-references to other label sections are left out.
Terconazole vaginal cream 0.4% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 0.4% is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.
Source: DailyMed label, set id 10e84353-93d2-461d-8b79-e9294df047ae, version 11, effective January 28, 2026. NDC 0168-0346, one of 7 listings for this product.
Terconazole, suppository
Indications and Usage, quoted from the label by Padagis Israel Pharmaceuticals Ltd (ANDA077149). Cross-references to other label sections are left out.
Terconazole Vaginal Suppositories, 80 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As this product is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.
Source: DailyMed label, set id 207e9cf2-e8ec-43d7-9c11-46283c9cdb37, version 15, effective August 11, 2026. NDC 45802-717, one of 3 listings for this product.
Questions
What is terconazole used for?
The FDA label says: “Terconazole vaginal cream 0.4% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 0.4% is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.”
What drug class is terconazole?
FDA lists terconazole in the Azole Antifungal 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.