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NDC 00536-1134-28 Miconazole Nitrate 20 mg/g Details
Miconazole Nitrate 20 mg/g
Miconazole Nitrate is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories, Inc.. The primary component is MICONAZOLE NITRATE.
MedlinePlus Drug Summary
Topical miconazole is used to treat tinea corporis(ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), and tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes). Miconazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection. Not all products should be used to treat all of these conditions. Please read the label for each product to select the one to treat your condition.
Related Packages: 00536-1134-28Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Miconazole Topical
Product Information
| NDC | 00536-1134 |
|---|---|
| Product ID | 0536-1134_bbac48c4-ed9c-4713-ae82-def7e66d1316 |
| Associated GPIs | 90154050103705 |
| GCN Sequence Number | 007366 |
| GCN Sequence Number Description | miconazole nitrate CREAM (G) 2 % TOPICAL |
| HIC3 | Q5F |
| HIC3 Description | TOPICAL ANTIFUNGALS |
| GCN | 30400 |
| 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 | TOPICAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/g |
| Substance Name | MICONAZOLE NITRATE |
| Labeler Name | Rugby Laboratories, Inc. |
| Pharmaceutical Class | Azole Antifungal [EPC], Azoles [CS] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part333C |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00536-1134-28 (00536113428)
| NDC Package Code | 0536-1134-28 |
|---|---|
| Billing NDC | 00536113428 |
| Package | 1 TUBE in 1 CARTON (0536-1134-28) / 30 g in 1 TUBE |
| Marketing Start Date | 2017-05-19 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.13911 |
| Pricing Unit | GM |
| Effective Date | 2024-02-21 |
| NDC Description | MICONAZOLE 2% TOPICAL CREAM |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
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 34198e9c-4856-4ba0-b78b-9c3b28baff0d Details
Uses
Warnings
Directions
- clean the affected area and dry thoroughly
- apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
- supervise children in the use of this product
- for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
- for athlete's foot and ringworm: use daily for 4 weeks
- for jock itch: use daily for 2 weeks
- not effective on the scalp or nails
Other information
Inactive ingredients
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
INGREDIENTS AND APPEARANCE
| MICONAZOLE NITRATE
miconazole nitrate cream |
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| Labeler - Rugby Laboratories, Inc. (079246066) |
Revised: 6/2017
Document Id: bbac48c4-ed9c-4713-ae82-def7e66d1316
Set id: 34198e9c-4856-4ba0-b78b-9c3b28baff0d
Version: 1
Effective Time: 20170612