Label: MONISTAT 3 COMBINATION PACK- miconazole nitrate kit
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Contains inactivated NDC Code(s)
NDC Code(s): 63736-018-03 - Packager: Insight Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated August 2, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- 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
- if you do not get complete relief ask a doctor before using another product.
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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 away applicator after use.
- external cream: 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
- Other information
- Inactive ingredients
- QUESTIONS
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PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - Kit Carton
3 DAY TREATMENT • CREAM
MONISTAT® 3
Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Cream (2%)
(Miconazole Nitrate 200 mg per applicator plus 2% external vulvar cream)
VAGINAL ANTIFUNGALCLINICALLY PROVEN
MULTI-SYMPTOM RELIEFCURES MOST VAGINAL YEAST INFECTIONS
and relieves associated external itching and irritationCOMBINATION PACK
Net Wt. 0.18 oz. (5g) each applicator • 0.32 oz. (9g) tube
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INGREDIENTS AND APPEARANCE
MONISTAT 3 COMBINATION PACK
miconazole nitrate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-018 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63736-018-03 1 in 1 PACKAGE, COMBINATION 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 MONISTAT 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 COCONUT OIL (UNII: JY81OXM1OM) HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 3 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020670 12/10/2009 Part 2 of 2 MICONAZOLE NITRATE
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) Cetyl Alcohol (UNII: 936JST6JCN) Isopropyl Myristate (UNII: 0RE8K4LNJS) Polysorbate 60 (UNII: CAL22UVI4M) Potassium Hydroxide (UNII: WZH3C48M4T) Propylene glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Stearyl Alcohol (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 9 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020670 12/10/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020670 12/10/2009 Labeler - Insight Pharmaceuticals (176792315) Establishment Name Address ID/FEI Business Operations Jubilant 246762764 MANUFACTURE(63736-018)