![MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [WAL-MART STORES INC]](https://medic.hrt.org//dailymed/images/bb542dd6-560a-4dd3-9974-69209c6d1cef/miconazole-3-combination-pack-1.jpg)
| NDC | 49035-731-43 |
| Set ID | bb542dd6-560a-4dd3-9974-69209c6d1cef |
| Category | HUMAN OTC DRUG LABEL |
| Packager | EQUATE (Wal-Mart Stores, Inc.) |
| Generic Name | |
| Product Class | Azole Antifungal |
| Product Number | |
| Application Number | ANDA074926 |
- Drug Facts
- Active ingredients
- Purpose
- Uses
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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
- 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 or 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
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Directions
- before using this product read the enclosed consumer information leaflet for complete directions and information
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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. Gently apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed.
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children under 12 years of age: ask a doctor
- Other information
- Inactive ingredients
- Questions?
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Principal Display Panel
equate™
Compare to
Monistat®3
Active
Ingredients*3 Day Treatment
Miconazole
Combination Pack
Miconazole Nitrate Vaginal Suppositories, USP 200 mg
Miconazole Nitrate External Vulvar Cream, 2%Vaginal Antifungal
- Cures most vaginal yeast infections
- Relieves associated external itching and irritation
3 MICONAZOLE NITRATE VAGINAL SUPPOSITORIES, USP 200 mg PLUS
1 TUBE OF MICONAZOLE NITRATE EXTERNAL VULVAR CREAM - NET WT 0.32 OZ (9 g)
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INGREDIENTS AND APPEARANCE
MICONAZOLE 3 COMBINATION PACK
miconazole nitrate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-731 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-731-43 1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product 06/11/2007 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 06/11/2007 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 06/11/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074926 06/11/2007 Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)