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NDC 00884-0293-01 fungoid tincture 20 mg/mL Details
fungoid tincture 20 mg/mL
fungoid tincture is a TOPICAL TINCTURE in the HUMAN OTC DRUG category. It is labeled and distributed by Pedinol Pharmacal, 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: 00884-0293-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Miconazole Topical
Product Information
| NDC | 00884-0293 |
|---|---|
| Product ID | 0884-0293_5a414cfc-14d4-453a-8cef-ebe675f0153b |
| Associated GPIs | 90154050102020 |
| GCN Sequence Number | 021002 |
| GCN Sequence Number Description | miconazole nitrate TINCTURE 2 % TOPICAL |
| HIC3 | Q5F |
| HIC3 Description | TOPICAL ANTIFUNGALS |
| GCN | 30421 |
| HICL Sequence Number | 003031 |
| HICL Sequence Number Description | MICONAZOLE NITRATE |
| Brand/Generic | Brand |
| Proprietary Name | fungoid tincture |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | miconazole nitrate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TINCTURE |
| Route | TOPICAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/mL |
| Substance Name | MICONAZOLE NITRATE |
| Labeler Name | Pedinol Pharmacal, 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 00884-0293-01 (00884029301)
| NDC Package Code | 0884-0293-01 |
|---|---|
| Billing NDC | 00884029301 |
| Package | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0884-0293-01) / 29.57 mL in 1 BOTTLE, WITH APPLICATOR |
| Marketing Start Date | 2012-04-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 250d0a66-01d1-4aba-8f24-4cb4ca529fda 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 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
- •
- if condition persists longer, consult a doctor
- •
- this product is not effective on scalp or nails.
Fungoid Tincture – 1 fl. oz. (29.57 mL) Carton
INGREDIENTS AND APPEARANCE
| FUNGOID TINCTURE
miconazole nitrate tincture |
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| Labeler - Pedinol Pharmacal, Inc. (064737125) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| EMS Acquisition Corp. | 048602791 | MANUFACTURE(0884-0293) | |
Revised: 5/2020
Document Id: 5a414cfc-14d4-453a-8cef-ebe675f0153b
Set id: 250d0a66-01d1-4aba-8f24-4cb4ca529fda
Version: 7
Effective Time: 20200518