NDC | 49348-833-61 |
Set ID | 89132802-beb1-42f4-8da4-39918fc5c4dd |
Category | HUMAN OTC DRUG LABEL |
Packager | Strategic Sourcing Services LLC |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | ANDA073507 |
- Drug Facts
- Active ingredient (in each vaginal suppository)
- Purpose
- Use
-
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 a prescription blood thinning medicine, such as 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?
-
Principal display panel
COMPARETO MONISTAT® 7 ACTIVE INGREDIENT*
miconazole 7
Vaginal Suppositories
Miconazole Nitrate Vaginal
Suppositories, USP 100 mg
Vaginal antifungal
Cures most vaginal yeast infections
7 VAGINAL SUPPOSITORIES WITH 1 REUSABLE PLASTIC APPLICATOR
*This product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat®
Another Quality Product
Distributed by McKesson
6555 State Highway 161 Irving, TX 75039
- Package label
-
INGREDIENTS AND APPEARANCE
MICONAZOLE 7
miconazole nitrate suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-833 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-833-61 7 in 1 APPLICATOR; Type 0: Not a Combination Product 12/09/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA073507 12/09/2011 Labeler - Strategic Sourcing Services LLC (116956644)