Label: MICONAZOLE 3 COMBINATION PACK- miconazole nitrate kit
- NDC Code(s): 0904-5415-01
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 9, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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 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.
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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. 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
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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).
- Inactive ingredients
- Questions?
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Principal display panel
Compare to the active ingredient in Monistat® 3*
Miconazola 3
Combination Pack
Miconazole Nitrate Vaginal Suppositories, USP 200 mg
and Miconazole Nitrate Vaginal Cream, USP 2%
200 mg/2%
Vaginal Antifungal
Cures most vaginal yeast infections
Relieves associated external itching and irritation
3 Miconazole Nitrate Vaginal Suppositories, USP 200 mg
with 3 disposable applicators plus 1 tube of
Miconazole Nitrate Vaginal Cream, USP 2%
NET WT. 0.32 OZ (9g) TUBE
*This product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat® 3.
Retain carton for complete information.
Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive
Suite 233
Livonia, MI 48152, USA
- 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:0904-5415 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-5415-01 1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product 12/02/2002 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 3 in 0 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 12/02/2002 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 12/02/2002 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074926 12/02/2002 Labeler - Major Pharmaceuticals (191427277)
