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NDC 11673-0049-06 Miconazole 7 20 mg/g Details
Miconazole 7 20 mg/g
Miconazole 7 is a VAGINAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by TARGET Corporation. The primary component is MICONAZOLE NITRATE.
MedlinePlus Drug Summary
Vaginal miconazole is used to treat vaginal yeast infections in adults and children 12 years of age and older. Miconazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection.
Related Packages: 11673-0049-06Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Miconazole Vaginal
Product Information
| NDC | 11673-0049 |
|---|---|
| Product ID | 11673-049_04ff74ff-4dd3-43c5-8997-d7d9c9deef6b |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Miconazole 7 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Miconazole Nitrate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | VAGINAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/g |
| Substance Name | MICONAZOLE NITRATE |
| Labeler Name | TARGET Corporation |
| Pharmaceutical Class | Azole Antifungal [EPC], Azoles [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA074444 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 11673-0049-06 (11673004906)
| NDC Package Code | 11673-049-06 |
|---|---|
| Billing NDC | 11673004906 |
| Package | 1 TUBE, WITH APPLICATOR in 1 CARTON (11673-049-06) / 45 g in 1 TUBE, WITH APPLICATOR |
| Marketing Start Date | 2019-11-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL edaca770-bc76-4ac2-bad2-cf8e7de0c682 Details
Use
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:
- applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw away applicator after each 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
PRINCIPAL DISPLAY PANEL - 45 g Tube Carton
up&up™
NDC 11673-049-06
7 DISPOSABLE APPLICATORS
7-DAY VAGINAL CREAM
Compare to active ingredient in Monistat® 7*
7-day treatment
miconazole 7
miconazole nitrate vaginal cream USP (2%)
(miconazole nitrate 100 mg per application)
vaginal antifungal
cures most vaginal yeast infections and relieves
associated external itching and irritation
7-day vaginal cream with disposable applicators
educational brochure enclosed
NET WT 1.5 OZ (45 g) TUBE + 7 DISPOSABLE APPLICATORS
INGREDIENTS AND APPEARANCE
| MICONAZOLE 7
miconazole nitrate cream |
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| Labeler - TARGET Corporation (006961700) |