![MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CVS PHARMACY]](https://medic.hrt.org//dailymed/images/65c99592-7c11-41fc-8296-aad0a8f39926/miconazole-3-combination-pack-1.jpg)
| NDC | 59779-773-03, 59779-773-43 |
| Set ID | 65c99592-7c11-41fc-8296-aad0a8f39926 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | CVS Pharmacy |
| Generic Name | |
| Product Class | Azole Antifungal |
| Product Number | |
| Application Number | ANDA074926 |
- Drug Facts
- Active ingredients
- Purpose
- Uses
-
Warnings
For vaginal use only
Ask a doctor before use if you have
-
vaginal itching and discomfort for the first time
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lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
- vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
- 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 and bruising may occur.
When using this product
- do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs).
- do not have vaginal intercourse
- mild increase in vaginal burning, itching or irritation may occur.
-
vaginal itching and discomfort for the first time
-
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:
- suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Throw applicator away after use.
-
external cream: Use cap to puncture seal. Squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed.
- children under 12 years of age: ask a doctor
- before using this product read the enclosed consumer information leaflet for complete directions and information
-
Other information
- do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped)
- do not use if seal over tube opening has been punctured or is not visible
- do not purchase if carton is open
- store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F).
- do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped)
- Inactive ingredients
- Questions?
-
Principal display panel
Compare to the active ingredient in Monistat®3
3-Dat Treatment
M-ZOLE 3
Combination Pack
MICONAZOLE NITRATE VAGINAL SUPPOSITORIES, USP 200 mg and
NICONAZOLE NITRATE VAGINAL CREAM, USP 2%
Vaginal antifungal
Cures most vaginal yeast infections and relieves associated external itching and irritation
NET WT Z (g)
*This product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat® 3
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
- Package label
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INGREDIENTS AND APPEARANCE
MICONAZOLE 3 COMBINATION PACK
miconazole nitrate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-773 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-773-03 1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product 03/01/2001 12/31/2014 2 NDC:59779-773-43 1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product 03/01/2001 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 3 Part 2 1 TUBE 9 g Part 1 of 2 MICONAZOLE 3
miconazole nitrate suppositoryProduct Information Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 200 mg Inactive Ingredients Ingredient Name Strength HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 3 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074926 03/01/2001 Part 2 of 2 MICONAZOLE 3
miconazole nitrate creamProduct Information Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 10 mg in 0.5 g Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) MINERAL OIL (UNII: T5L8T28FGP) APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ) PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 9 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074926 03/01/2001 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074926 03/01/2001 Labeler - CVS Pharmacy (062312574)
