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NDC 63868-0198-45 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 QUALITY CHOICE (Chain Drug Marketing Association). 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: 63868-0198-45Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Miconazole Vaginal
Product Information
| NDC | 63868-0198 |
|---|---|
| Product ID | 63868-198_d353be3c-4a6d-4c33-b443-1a5fe60a7531 |
| Associated GPIs | 55104050103710 |
| GCN Sequence Number | 007003 |
| GCN Sequence Number Description | miconazole nitrate CREAM/APPL 2 % VAGINAL |
| HIC3 | Q4F |
| HIC3 Description | VAGINAL ANTIFUNGALS |
| GCN | 28380 |
| HICL Sequence Number | 003031 |
| HICL Sequence Number Description | MICONAZOLE NITRATE |
| Brand/Generic | Generic |
| 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 | QUALITY CHOICE (Chain Drug Marketing Association) |
| Pharmaceutical Class | Azole Antifungal [EPC], Azoles [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA074164 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63868-0198-45 (63868019845)
| NDC Package Code | 63868-198-45 |
|---|---|
| Billing NDC | 63868019845 |
| Package | 1 TUBE, WITH APPLICATOR in 1 CARTON (63868-198-45) / 45 g in 1 TUBE, WITH APPLICATOR |
| Marketing Start Date | 2010-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.1304 |
| Pricing Unit | GM |
| Effective Date | 2022-11-23 |
| NDC Description | QC MICONAZOLE-7 CREAM |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2022-11-23 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL 68667d2e-d4d0-46e7-9d84-0f23fdac1cf7 Details
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:
• applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator 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
- to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
- do not use if foil seal on tube opening is broken or missing
- do not purchase if carton is open
- store at room temperature 20°-25°C (68°-77°F)
- before using any medication, read all label directions. Keep carton, it contains important information.
Inactive ingredients
Principal display panel
*Compare to the active ingredient in MONISTAT® 7 Vaginal Cream
Miconazole 7
Miconazole Nitrate Vaginal Cream USP, 2%
Vaginal Antifungal
(Miconazole Nitrate 100 mg per applicator)
Cures Most Vaginal Yeast Infections and Relieves
Associated External Itching and Irritation
OZ NET WT (g) Tube Vaginal Cream with Reusable Applicator
*This product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat®.
Distributed by CDMA, Inc.
Novi, MI 48375
www.qualitychoice.com
INGREDIENTS AND APPEARANCE
| MICONAZOLE 7
miconazole nitrate cream |
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| Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774) |
Revised: 9/2022
Document Id: d353be3c-4a6d-4c33-b443-1a5fe60a7531
Set id: 68667d2e-d4d0-46e7-9d84-0f23fdac1cf7
Version: 11
Effective Time: 20220930