• 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.
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 healthcare professional • Supervise children in the use of this product. For athlete's foot: • 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 sho...
• 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.
Stop use and ask a healthcare professional if • 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).
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 healthcare professional • Supervise children in the use of this product.
For athlete's foot: • 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.
For ringworm: 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
Relabeled By: Preferred Pharmaceuticals Inc.
68788-8845-3
| 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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68788-8845-3 | MICONAZOLE Nitrate 2% Cream ANTIFUNGAL | 30 g in 1 TUBE | CREAM | 30 | 1 | |
| 68788-8845-3 | MICONAZOLE Nitrate 2% Cream ANTIFUNGAL | 1 in 1 BOX | CREAM | 1 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-8845 | MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [PREFERRED PHARMACEUTICALS INC.] | 1 | Current NDC, 2 package rows | 20250326_14d2a661-a490-41ca-b84f-f2be3bc271b4.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-8845-3 | GM - Gram | 68788-8845 | 0a9b250c-7f23-4682-af64-35497e191509 | 1 | 2025-05-14 |
| 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 |
|---|---|
| 68788-8845 | 68788-8845-3 |
| 69396-014 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MICONAZOLE NITRATE | VW4H1CYW1K | ACTIB |
| CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE | 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 |
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 2% Cream ANTIFUNGAL | MICONAZOLE NITRATE | Preferred Pharmaceuticals Inc. | 14d2a661-a490-41ca-b84f-f2be3bc271b4 | 2025-03-24 | Warnings | 68788-8845-3 68788-8845 68788884503 14d2a661-a490-41ca-b84f-f2be3bc271b4 14d2a661-a490-41ca-b84f-f2be3bc271b4 |
Adverse event summaries are temporarily unavailable. Other product information remains available.