![MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [WAL-MART STORES INC]](https://medic.hrt.org//dailymed/images/b9d401fb-e84b-44d4-a684-d08c6901af2e/miconazole-7---miconazole-cream-1.jpg)
| NDC | 49035-730-07 |
| Set ID | b9d401fb-e84b-44d4-a684-d08c6901af2e |
| Category | HUMAN OTC DRUG LABEL |
| Packager | EQUATE (Wal-Mart Stores, Inc.) |
| Generic Name | |
| Product Class | Azole Antifungal |
| Product Number | |
| Application Number | ANDA074164 |
- Drug Facts
- 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
-
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 to 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
- Other information
- Inactive ingredients
- Questions?
-
Principal display panel
equate™
NDC 49035-730-07
Compare to Monistat® 7 Active Ingredient*
7 Day Treatment
Miconazole 7
Miconazole Nitrate Vaginal Cream, USP 2%
(Miconazole Nitrate 100 mg per applicator)
Vaginal Antifungal
• Cures most vaginal yeast infections
• Relieves associated external itching and irritation
7 Day Vaginal Cream (1 Tube) with
7 Disposable Applicators7 DISPOSABLE APPLICATORS
NET WT 1.59 OZ (45 g) 1 TUBE
-
INGREDIENTS AND APPEARANCE
MICONAZOLE 7
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-730 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) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) MINERAL OIL (UNII: T5L8T28FGP) APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ) PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-730-07 1 in 1 CARTON 03/03/2008 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 ANDA ANDA074164 03/03/2008 Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)