Label: MICONAZOLE 7- miconazole nitrate suppository
- NDC Code(s): 61269-736-07
- Packager: H2-Pharma, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 17, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each vaginal suppository)
- Purpose
- Use
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Warnings
For vaginal use only
Ask a doctor before use if you have
- vaginal itching and discomfort for the first time
- vaginal yeast infections often (such as once a month or 3 in 6 months). You may have a more serious condition. You could be pregnant or have a medical condition, such as diabetes or a weakened immune system.
- lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
- been exposed to the human immunodeficiency virus (HIV) that causes AIDS
Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur.
When using this product
- do not use tampons, douches, spermicides or other vaginal products
- do not use condoms or diaphragms. They may be damaged by this product and not prevent pregnancy or sexually transmitted diseases (STDs).
- do not have vaginal intercourse (sex)
- mild increase in vaginal burning, itching or irritation may occur
- Directions
- Other information
- Inactive ingredient
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 100 mg Suppository Box
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INGREDIENTS AND APPEARANCE
MICONAZOLE 7
miconazole nitrate suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61269-736 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole Nitrate (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) Miconazole Nitrate 100 mg Inactive Ingredients Ingredient Name Strength HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP) PALM KERNEL OIL (UNII: B0S90M0233) Product Characteristics Color WHITE Score Shape OVAL Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61269-736-07 7 in 1 BOX; Type 0: Not a Combination Product 05/24/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA073507 05/24/2021 Labeler - H2-Pharma, LLC (028473634)