Search by Drug Name or NDC
NDC 51672-2035-07 Miconazole Nitrate 20 mg/g Details
Miconazole Nitrate 20 mg/g
Miconazole Nitrate is a VAGINAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Taro Pharmaceuticals U.S.A., Inc.. 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: 51672-2035-07Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Miconazole Vaginal
Product Information
| NDC | 51672-2035 |
|---|---|
| Product ID | 51672-2035_f71c79c6-c274-4175-801e-5fa6e11086dd |
| 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 Nitrate |
| 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 | Taro Pharmaceuticals U.S.A., Inc. |
| 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 51672-2035-07 (51672203507)
| NDC Package Code | 51672-2035-7 |
|---|---|
| Billing NDC | 51672203507 |
| Package | 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-2035-7) / 45 g in 1 TUBE, WITH APPLICATOR |
| Marketing Start Date | 1997-01-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6b34d0be-4bcd-4dff-b732-7fbd46765019 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
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 45 g Tube Carton
CURES most vaginal YEAST INFECTIONS
Relieves associated external itching and irritation
NDC 51672-2035-6
7 Day Treatment
7 Day Vaginal Cream
Miconazole Nitrate Vaginal Cream USP (2%)
(Miconazole Nitrate 100 mg per application)
Vaginal Antifungal
One 45 g (1.5 oz) tube of Miconazole Nitrate Vaginal Cream USP (2%)
& 1 Reusable Applicator
Consumer Information Leaflet Enclosed
INGREDIENTS AND APPEARANCE
| MICONAZOLE NITRATE
miconazole nitrate cream |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Taro Pharmaceuticals Inc. | 206263295 | MANUFACTURE(51672-2035) | |
Revised: 1/2020
Document Id: f71c79c6-c274-4175-801e-5fa6e11086dd
Set id: 6b34d0be-4bcd-4dff-b732-7fbd46765019
Version: 2
Effective Time: 20200122