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NDC 49348-0689-72 SUNMARK MICONAZOLE NITRATE 20 mg/g Details
SUNMARK MICONAZOLE NITRATE 20 mg/g
SUNMARK MICONAZOLE NITRATE is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. 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: 49348-0689-72Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Miconazole Topical
Product Information
| NDC | 49348-0689 |
|---|---|
| Product ID | 49348-689_7de1accb-52dc-47ab-a690-17da115b4b1c |
| 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 | SUNMARK MICONAZOLE NITRATE |
| Proprietary Name Suffix | antifungal |
| 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 | Strategic Sourcing Services LLC |
| 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 49348-0689-72 (49348068972)
| NDC Package Code | 49348-689-72 |
|---|---|
| Billing NDC | 49348068972 |
| Package | 1 TUBE in 1 CARTON (49348-689-72) / 30 g in 1 TUBE |
| Marketing Start Date | 1991-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.13911 |
| Pricing Unit | GM |
| Effective Date | 2024-02-21 |
| NDC Description | SM 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 |
Standard Product Labeling (SPL)/Prescribing Information SPL 7c15d95a-5b89-4789-8c91-3f61d7ec7707 Details
Uses
Warnings
Directions
This product is not effective on the scalp or nails.
For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
- 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; change shoes and socks at least once daily
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
INGREDIENTS AND APPEARANCE
| SUNMARK MICONAZOLE NITRATE
ANTIFUNGAL
miconazole nitrate cream |
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| Labeler - Strategic Sourcing Services LLC (116956644) |