OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Miconazole Nitrate 2%
Active Ingredient
Miconazole Nitrate 2%
Purpose
Antifungal
Uses
Warnings
Do not use on children under 2 years of age except under the advice and supervision of a doctor.
For external use only.
When using this product avoid contact with eyes.
Stop using this product and ask a doctor
Keep this and all drugs out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
wash affected area and dry thoroughly
Apply a thin layer 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 a day
for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks
if conditions persist longer, ask a doctor
this product is not effective on the scalp or nails.
Other information
Inactive Ingredients
Purified water, cetostearyl alcohol, cetomacrogol-1000, mineral oil, petrolatum, propyleneglycol, sodium phosphate, chlorocresol.
PRINCIPAL DISPLAY PANEL
Anti-Fungal Cream
NET WT 0.5 OZ (14 g)
| Class | Version | Type | Effective |
|---|---|---|---|
| MICONAZOLE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3a55f4fb-5aec-4c88-0ff7-4d608ad4866a | Product name | 1 | 20140508 |
| 5b9a7965-36d2-8412-dcaf-f76a65411611 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52000-061-01 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-314d-fb37-e063-e6dba90a4e07 | Anti-Fungal Cream |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52000-061-01 | Anti-Fungal | 1 in 1 BOX | CREAM | 1 | 2 | |
| 52000-061-01 | Anti-Fungal | 14 g in 1 TUBE | CREAM | 14 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 52000-061 | 52000-061-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| CETETH-20 | I835H2IHHX | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM PHOSPHATE | SE337SVY37 | IACT |
| CHLOROCRESOL | 36W53O7109 | IACT |
| MICONAZOLE NITRATE | VW4H1CYW1K | ACTIB |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| abef15f7-3144-49c0-8131-138668561d54 | 91a8d893-c51f-42de-8e7f-be496507fe7c | 2024-12-03 | Warnings | abef15f7-3144-49c0-8131-138668561d54 91a8d893-c51f-42de-8e7f-be496507fe7c |
Adverse event summaries are temporarily unavailable. Other product information remains available.