Topco Miconazole 3
Topco Miconazole 3 is an FDA drug label for the active ingredient MICONAZOLE NITRATE manufactured by Topco Associates LLC administered by VAGINAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20210210.
Generic: MICONAZOLE NITRATE
Manufacturer: Topco Associates LLC
Product Type: HUMAN OTC DRUG
Route: VAGINAL
Dosage Form:
NDC: 36800-782
Application: ANDA091366
Effective: 20210210
Active Ingredients: Active ingredient Miconazole nitrate 4%
Indications & Usage
Uses • treats vaginal yeast infections
Dosage & Administration
Directions • before using this product read the enclosed consumer information leaflet for complete directions and information • adults and children 12 years of age and over: • insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Throw applicator away after use. • children under 12 years of age: ask a doctor
Contraindications
Not available.
Warnings
Warnings For vaginal use only
Adverse Reactions
Not available.
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