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NDC 69842-0950-01 Miconazole 3 Details
Miconazole 3
Miconazole 3 is a TOPICAL; VAGINAL KIT in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. The primary component is .
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: 69842-0950-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Miconazole Vaginal
Product Information
| NDC | 69842-0950 |
|---|---|
| Product ID | 69842-950_02e48e12-a4e5-4d00-802f-96225b2c80cb |
| 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 3 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Miconazole nitrate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | KIT |
| Route | TOPICAL; VAGINAL |
| Active Ingredient Strength | n/a |
| Active Ingredient Units | n/a |
| Substance Name | n/a |
| Labeler Name | CVS Pharmacy |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA020670 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 69842-0950-01 (69842095001)
| NDC Package Code | 69842-950-01 |
|---|---|
| Billing NDC | 69842095001 |
| Package | 1 KIT in 1 PACKAGE, COMBINATION (69842-950-01) * 1 INSERT in 1 APPLICATOR * 9 g in 1 TUBE |
| Marketing Start Date | 1996-04-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6e027927-1532-46ba-8839-6ee4416d0b60 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:
•vaginal insert: with a disposable applicator place the insert into the vagina at bedtime. Throw away applicator after use.
•external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the 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
Inactive ingredients
PRINCIPAL DISPLAY PANEL
Compare to the active ingredients of Monistat® 3
3-Day Treatment; 3-Step System
Yeast Infection Relief
Miconazole 3
MICONAZOLE NITRATE VAGINAL INSERTS (200 mg)
MICONAZOLE NITRATE CREAM (2%)
Vaginal Antifungal
Combination Pack
- Cures most vaginal yeast infections
- Relieves associated external itching & irritation
3 VAGINAL SOFTGEL INSERTS, 3 APPLICATORS, 1 EXTERNAL CREAM, 4 FEMININE WIPES
NET WT 3 VAGINAL SOFTGEL INSERTS + 0.32 OZ (9 g) TUBE
INGREDIENTS AND APPEARANCE
| MICONAZOLE 3
miconazole nitrate kit |
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| Labeler - CVS Pharmacy (062312574) |
| Registrant - Insight Pharmaceuticals (078774214) |