Label: MONISTAT 7 WITH REUSABLE APPLICATOR- miconazole nitrate cream
If swallowed, get medical help or contact a Poison Control Center right away.
- before using this product read the enclosed consumer information leaflet for complete directions and information
- adults and children 12 years of age and over:
○ applicator: Insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use.
○ use the same tube of cream if you have itching and irritation on the skin outside the vagina. 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.
- do not use if seal over tube opening has been punctured
- do not purchase if carton is open
- store at 20°-25°C (68°-77°F)
benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol.
If you have any questions or comments, please call 1-877-666-4782
PRINCIPAL DISPLAY PANEL MONISTAT® 7 Miconazole Nitrate Vaginal Cream (2%) Vaginal Antifungal 1 Reusable Applicator Net Wt. 1.59 oz. (45g) Tube " />
MONISTAT ® 7
Miconazole Nitrate Vaginal Cream (2%) Vaginal Antifungal 1 Reusable Applicator Net Wt. 1.59 oz. (45g) Tube
| Product Information |
| Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC:63736-025 |
| Route of Administration | VAGINAL |
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
|---|
| Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) | Miconazole Nitrate | 20 mg in 1 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 | NDC:63736-025-15 | 1 in 1 CARTON | 04/26/1993 |
|---|
| 1 | 45 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product |
|---|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
|---|
| NDA | NDA017450 | 04/26/1993 |
| Labeler - Insight Pharmaceuticals LLC (055665422) |
