Indications and uses
proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm for effective relief of itching, scaling, cracking, burning, and discomfort
Miconazole Nitrate
- Manufacturer
- H2-Pharma, LLC
- Effective date
- 2024-12-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:43:49
Label at a glance#
ProductMiconazole Nitrate
Active ingredientMICONAZOLE NITRATE
Label structure11 sections
Dosage and administration
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 doctor supervise children in the use of this product for athlete's foot: pay special attention to the 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; fo...
Storage and handling
do not use if foil seal on tube opening is broken or missing to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use store at room temperature 15°-30°C (59°-86°F) before using any medication, read all label directions. Keep carton, it contains important information.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient
Miconazole nitrate USP, 2%
Purpose
Antifungal
Uses
- proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm
- for effective relief of itching, scaling, cracking, burning, and discomfort
Warnings
For external use only
OTC - DO NOT USE SECTION
Do not use on children under 2 years of age unless directed by a doctor.
OTC - WHEN USING SECTION
When using this product, avoid contact with the eyes.
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- 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 doctor
- supervise children in the use of this product
- for athlete's foot: pay special attention to the 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
- do not use if foil seal on tube opening is broken or missing
- to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
- store at room temperature 15°-30°C (59°-86°F)
- before using any medication, read all label directions. Keep carton, it contains important information.
Inactive ingredients
benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
SPL UNCLASSIFIED SECTION
Distributed by: H2-Pharma, LLC
Montgomery, AL 36117
PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
Miconazole Nitrate Cream USP, 2%
Antifungal Cream
NDC 61269-735-56
*Compare to the active ingredient in
Micatin® Antifungal Cream
Soothes itching, scaling, cracking, and burning | Cures most athlete's foot, jock itch, and ringworm | Clinically proven
Net wt. 1 oz (28 g)
H2 pharma
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61269-735-14 | GM - Gram | 61269-735 | d8f29709-852e-47b8-aa8b-855bed7d7ff5 | 1 | 2021-07-15 |
| 61269-735-42 | GM - Gram | 61269-735 | 0120fd90-5843-41fa-beea-8e0b27809841 | 1 | 2021-07-15 |
| 61269-735-56 | GM - Gram | 61269-735 | 47f4642f-3ed7-47e4-933e-190f35e5bbf5 | 1 | 2021-07-15 |
Products#
Every source-derived product name is available through these pages.
- Miconazole Nitrate
- MICONAZOLE
- BENZOIC ACID
- BUTYLATED HYDROXYANISOLE
- MINERAL OIL
- APRICOT KERNEL OIL PEG-6 ESTERS
- PEGOXOL 7 STEARATE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61269-735 | 61269-735-14, 61269-735-56, 61269-735-42 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MICONAZOLE NITRATE | VW4H1CYW1K | ACTIB |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| BUTYLATED HYDROXYANISOLE | REK4960K2U | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| APRICOT KERNEL OIL PEG-6 ESTERS | DRG3KJZ1TJ | IACT |
| PEGOXOL 7 STEARATE | 3EW5AXE5X5 | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| f500946e-44ef-46ea-89e6-fd3f712d7481 | 3bfb86ec-55b0-4151-9b74-7243a55dca67 | 2024-12-30 | Warnings | f500946e-44ef-46ea-89e6-fd3f712d7481 3bfb86ec-55b0-4151-9b74-7243a55dca67 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.