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NDC 68071-1703-07 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 NuCare Pharmaceuticals,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: 68071-1703-07Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Miconazole Vaginal
Product Information
NDC | 68071-1703 |
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Product ID | 68071-1703_d6ac754b-27df-2937-e053-2995a90a2954 |
Associated GPIs | 55104050103710 |
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 | NuCare Pharmaceuticals,Inc. |
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 68071-1703-07 (68071170307)
NDC Package Code | 68071-1703-7 |
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Billing NDC | 68071170307 |
Package | 45 g in 1 BOX (68071-1703-7) |
Marketing Start Date | 2019-03-04 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 8349d8f8-d210-377a-e053-2a91aa0a0233 Details
Uses
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
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.
Stop use and ask a doctor if
Keep out of reach of children.
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
INGREDIENTS AND APPEARANCE
MICONAZOLE 7
miconazole nitrate cream |
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Labeler - NuCare Pharmaceuticals,Inc. (010632300) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
NuCare Pharmaceuticals,Inc. | 010632300 | relabel(68071-1703) |
Revised: 1/2022
Document Id: d6ac754b-27df-2937-e053-2995a90a2954
Set id: 8349d8f8-d210-377a-e053-2a91aa0a0233
Version: 3
Effective Time: 20220128