NDC | 63736-026-15 |
Set ID | c4b68aff-e95f-47ae-b190-6a671bef1877 |
Category | HUMAN OTC DRUG LABEL |
Packager | Insight Pharmaceuticals LLC |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | NDA017450 |
- Active ingredient
- 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
-
vaginal itching and discomfort for the first time
-
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:
○ applicator: Insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw applicator away 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.
- before using this product read the enclosed consumer information leaflet for complete directions and information
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MONISTAT 7 7-DAY DISPOSABLE APPLICATORS
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-026 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:63736-026-15 7 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)