NDC | 69842-950-01 |
Set ID | 6e027927-1532-46ba-8839-6ee4416d0b60 |
Category | HUMAN OTC DRUG LABEL |
Packager | CVS Pharmacy |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | NDA020670 |
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Active ingredients
- Purpose
- Uses
-
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
-
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 a disposable applicator place the insert into the vagina at bedtime. 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
- Inactive ingredients
- Questions? call toll-free 1-855-590-5695
-
PRINCIPAL DISPLAY PANEL
Compare to the active ingredients of Monistat® 3
3-Day Treatment; 3-Step System
Yeast Infection Relief
Miconazole 3
MICONAZOLE NITRATE VAGINAL INSERTS (200 mg)
MICONAZOLE NITRATE CREAM (2%)
Vaginal Antifungal
Combination Pack- Cures most vaginal yeast infections
- Relieves associated external itching & irritation
3 VAGINAL SOFTGEL INSERTS, 3 APPLICATORS, 1 EXTERNAL CREAM, 4 FEMININE WIPES
NET WT 3 VAGINAL SOFTGEL INSERTS + 0.32 OZ (9 g) TUBE - Cures most vaginal yeast infections
-
INGREDIENTS AND APPEARANCE
MICONAZOLE 3
miconazole nitrate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-950 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-950-01 1 in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package 04/16/1996 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 3 APPLICATOR 3 Part 2 1 TUBE 9 g Part 1 of 2 MICONAZOLE NITRATE
miconazole nitrate insertProduct 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 GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) CORN OIL (UNII: 8470G57WFM) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020670 04/16/1996 Part 2 of 2 MICONAZOLE NITRATE
miconazole nitrate creamProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g in 100 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; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020670 04/16/1996 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020670 04/16/1996 Labeler - CVS Pharmacy (062312574) Registrant - Insight Pharmaceuticals (078774214)