Monistat 1 Combination Pack
Name: Monistat 1 Combination Pack
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:
- vaginal insert: with the applicator, place the vaginal insert into the vagina. 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 (vulva). Use 2 times daily for up to 7 days, as needed.
- children under 12 years of age: ask a doctor
PRINCIPAL DISPLAY PANEL - Kit Carton
NDC-30014-012-30
MONISTAT® 1
COMBINATION PACK
Miconazole Nitrate Vaginal Insert (1200 mg) and Miconazole Nitrate Cream (2%)
CLINICALLY PROVEN
ORTHO
STAYS IN PLACE
VAGINAL ANTIFUNGAL
CURES MOST VAGINAL YEAST INFECTIONS AND
RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION
1 OVULE® Insert with Applicator
Plus External Cream
ORTHO
Net Wt 1 OVULE® Insert
+ 0.32 oz (9g) Tube
Monistat 1 Combination Pack
miconazole nitrate kit |
| Product Information | | Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC:30014-012 | |
| Packaging | | # | Item Code | Package Description | | 1 | NDC:30014-012-30 | 1 KIT (KIT) in 1 PACKAGE, COMBINATION | |
| Quantity of Parts | | Part # | Package Quantity | Total Product Quantity | | Part 1 | 1 POUCH | 1 | | Part 2 | 1 TUBE | 9 g | |
| Part 1 of 2 | MICONAZOLE NITRATE
miconazole nitrate suppository | |
| Product Information | | | Route of Administration | VAGINAL | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | Miconazole Nitrate (Miconazole) | Miconazole Nitrate | 1200 mg | |
|
| Packaging | | # | Item Code | Package Description | | 1 | | 1 SUPPOSITORY (SUPPOSITORY) in 1 POUCH | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA | NDA021308 | 04/15/2010 | | |
| Part 2 of 2 | MICONASOLE NITRATE
miconazole nitrate cream | |
| Product Information | | | Route of Administration | VAGINAL | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | Miconazole Nitrate (Miconazole) | Miconazole Nitrate | 20 mg in 1 g | |
|
| Packaging | | # | Item Code | Package Description | | 1 | | 9 g in 1 TUBE | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA | NDA021308 | 04/15/2010 | | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA | NDA021308 | 04/15/2010 | | |
| Labeler - McNeil, PPC, Inc. (801375143) |
Revised: 04/2010 McNeil, PPC, Inc.
