• proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) • 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 doctor • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks a...
• 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. Relabeled By: Preferred Pharmaceuticals Inc.
www.majorpharmaceuticals.comMiconazole Nitrate 2%
Anti-Fungal
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 doctor. When using this product avoid contact with the eyes.
Stop use and ask a doctor 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).
Distributed by:
Rugby Laboratories
Indianapolis, IN. 46268
800-616-2471
This product is not manufactured or distributed by Wellspring Pharmaceutical Corporation owner of the registered trademark Micatin.
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 doctor • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks at least once daily.
For ringworm: Use daily for 4 weeks. If condition persists, consult a doctor.
For jock itch: Use daily for 2 weeks. If condition persists longer, consult a doctor.
This product is not effective on the scalp or nails.
Inactive ingredientsCarbomer, alcohol, cetostearyl alcohol, dimethyl sulfoxide, edetate disodium, ethylparaben, glycerol, mineral oil, mono and di glycerides, polyoxyethylene lauryl ether, 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.
Relabeled By: Preferred Pharmaceuticals Inc.
| 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 |
|---|---|---|---|---|---|---|
| 68788-8895-3 | MICONAZOLE Nitrate 2% Cream ANTIFUNGAL | 28.3 g in 1 TUBE | CREAM | 28.3 | 1 | |
| 68788-8895-3 | MICONAZOLE Nitrate 2% Cream ANTIFUNGAL | 1 in 1 BOX | CREAM | 1 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-8895-3 | GM - Gram | 68788-8895 | 6081a260-03a0-4a4b-8f07-b41b567f1696 | 1 | 2025-08-11 |
| 0536-1375-75 | GM - Gram | 0536-1375 | 4146e11a-5606-4fc8-a00f-0e0fcd2a9f4d | 1 | 2023-03-13 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68788-8895 | 68788-8895-3 |
| 0536-1375 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| DIMETHYL SULFOXIDE | YOW8V9698H | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| ETHYLPARABEN | 14255EXE39 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| LAURETH-30 | W9D845551A | IACT |
| WATER | 059QF0KO0R | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| MICONAZOLE NITRATE | VW4H1CYW1K | ACTIB |
| CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE | 0A5MM307FC | IACT |
| GLYCERYL MONO- AND DIPALMITOSTEARATE | KC98RO82HJ | IACT |
| ALCOHOL | 3K9958V90M | 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 | Preferred Pharmaceuticals Inc. | cca84334-2e2d-4991-9d1e-d5b7c9ffd392 | 2025-08-01 | Warnings | 68788-8895-3 68788-8895 68788889503 cca84334-2e2d-4991-9d1e-d5b7c9ffd392 cca84334-2e2d-4991-9d1e-d5b7c9ffd392 |
| MICONAZOLE Nitrate 2% Cream ANTIFUNGAL | MICONAZOLE NITRATE | Rugby | f420de00-408f-9a2c-e053-2995a90adced | 2024-12-17 | Warnings | 0536-1375 |
Adverse event summaries are temporarily unavailable. Other product information remains available.