Search by Drug Name or NDC
NDC 63187-0885-15 Antifungal 20 mg/g Details
Antifungal 20 mg/g
Antifungal is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. 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: 63187-0885-15Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Miconazole Topical
Product Information
NDC | 63187-0885 |
---|---|
Product ID | 63187-885_bb56f31c-5b87-409e-b5ec-bc410c4607e0 |
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 | Antifungal |
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 | Proficient Rx LP |
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 63187-0885-15 (63187088515)
NDC Package Code | 63187-885-15 |
---|---|
Billing NDC | 63187088515 |
Package | 1 TUBE in 1 CARTON (63187-885-15) / 14 g in 1 TUBE |
Marketing Start Date | 2017-09-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 5e619dfa-4401-45bb-83c6-aaaa59203e5e Details
Uses
Stop use and ask a doctor if
SPL UNCLASSIFIED SECTION
Directions
- •
- wash 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
- •
- if condition lasts longer, contact a doctor
- •
- this product is not effective on the scalp or nails
Other information
Inactive ingredients
Questions?
Principal Display Panel
INGREDIENTS AND APPEARANCE
ANTIFUNGAL
miconazole nitrate cream |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
Labeler - Proficient Rx LP (079196022) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Proficient Rx LP | 079196022 | RELABEL(63187-885) |