proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea crurus), and ringworm (tinea capitis) relieves itching, scaling, cracking, burning and discomfort associated with these conditions.
• Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a healthcare professional • Supervise children in the use of this product. • Use daily for 4 weeks. If condition persists, consult a healthcare professional. • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks atleast once daily. Use daily for 4 weeks. If ...
• Store at 15° - 30° c (59° - 86° f)• Lot number and expiration date see crimp of tube or see box. • To open: Unscrew cap, tear safety seal off. You may report serious side effects to: QC@trifecta-pharma.com
www.trifecta-pharma.comMiconazole Nitrate 2%
Anti-Fungal
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
For external use only. Do not use if the safety-sealed tube is punctured or damaged.
Do not use on children under 2 years of age unless directed by a healthcare professional. When using this product avoid contact with the eyes.
• irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm) • Irritation occurs, or if there is no improvement within 2 weeks (for jock itch).
• Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a healthcare professional • Supervise children in the use of this product.
• Use daily for 4 weeks. If condition persists, consult a healthcare professional. • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks atleast once daily.
Use daily for 4 weeks. If condition persists, consult a healthcare professional.
For jock itch: Use daily for 2 weeks. If condition persists longer, consult a healthcare professional.
This product is not effective on the scalp or nails.
Inactive ingredients Carbomer, cetostearyl alcohol, dimethyl sulfoxide, edetate disodium, ethylparaben, glycerol, glyceryl distearate, mineral oil, peregal-o, purified water, stearic acid, triethanolamine, petrolatum.
• Store at 15° - 30° c (59° - 86° f)• Lot number and expiration date see crimp of tube or see box. • To open: Unscrew cap, tear safety seal off.
You may report serious side effects to: QC@trifecta-pharma.com
FAST RELIEF 100% GUARANTEED
Relieves Itching and Burning
Also Cures Athlete's Foot and Ringworm
Distributed by:
Trifecta Pharmaceuticals USA
TM
101 NE Third Avenue Suite 1500
Ft. Lauderdale, FL 33301 USA
www.trifecta-pharma.com
| 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 |
|---|---|---|---|---|---|
| 68071-3429-3 | 2025-03-04 | C162847 | 48780-1 | 2cef2736-672a-d83d-e063-dadaa90ab31f | MICONAZOLE Nitrate 2% Cream ANTIFUNGAL |
| 68071-3429-3 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-672a-d83d-e063-dadaa90ab31f | MICONAZOLE Nitrate 2% Cream ANTIFUNGAL |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-3429-3 | MICONAZOLE Nitrate | 30 g in 1 TUBE | CREAM | 30 | 2 | |
| 68071-3429-3 | MICONAZOLE Nitrate | 1 in 1 BOX | CREAM | 1 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-3429 | MICONAZOLE NITRATE CREAM [NUCARE PHARMACEUTICALS,INC.] | 2 | Current NDC, 2 package rows | 20250306_fd7dd2eb-03a7-ef1f-e053-6294a90a8557.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69396-014-05 | GM - Gram | 69396-014 | 67a4d687-f389-41b0-90b6-be0807a7d1e6 | 1 | 2024-01-04 |
| 69396-014-20 | GM - Gram | 69396-014 | 6d9d1334-578d-493a-b171-4ffa9ada0f5f | 1 | 2018-06-11 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68071-3429 | 68071-3429-3 |
| 69396-014 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARBOXYPOLYMETHYLENE | 0A5MM307FC | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| DIMETHYL SULFOXIDE | YOW8V9698H | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| ETHYLPARABEN | 14255EXE39 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| GLYCERYL DISTEARATE | 73071MW2KM | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| POLYOXYL 20 CETOSTEARYL ETHER | YRC528SWUY | IACT |
| WATER | 059QF0KO0R | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| PETROLATUM | 4T6H12BN9U | 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 |
|---|---|---|---|---|---|---|
| MICONAZOLE Nitrate 2% Cream ANTIFUNGAL | MICONAZOLE NITRATE | Trifecta Pharmaceuticals Usa Llc | 80217dbb-a0f0-414a-8d22-a9a346b017aa | 2026-03-31 | Warnings | 69396-014 |
| MICONAZOLE Nitrate | MICONAZOLE NITRATE | NuCare Pharmaceuticals,Inc. | fd7dd2eb-03a7-ef1f-e053-6294a90a8557 | 2025-02-04 | Warnings | 68071-3429-3 68071-3429 68071342903 2d587184-fc1e-2fda-e063-6394a90a32fa fd7dd2eb-03a7-ef1f-e053-6294a90a8557 |
Adverse event summaries are temporarily unavailable. Other product information remains available.