MICONAZOLE NITRATE
- Manufacturer
- DirectRx
- Effective date
- 2022-04-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:04:05
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Miconazole nitrate USP, 2%
OTC - PURPOSE SECTION
Antifungal
OTC - WHEN USING SECTION
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 SECTION
For external use only
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
there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
OTHER SAFETY 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.
INDICATIONS & USAGE SECTION
benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water
OTC - QUESTIONS SECTION
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
SPL UNCLASSIFIED SECTION
Distributed by: H2-Pharma, LLC
Montgomery, AL 36117
WARNINGS AND PRECAUTIONS SECTION
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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72189-345-28 | GM - Gram | 72189-345 | 93e715c0-e065-43bf-8135-c08986726366 | 1 | 2022-05-04 |
| 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
- MINERAL OIL
- BENZOIC ACID
- APRICOT KERNEL OIL PEG-6 ESTERS
- WATER
- BUTYLATED HYDROXYANISOLE
- PEGOXOL 7 STEARATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72189-345 | 72189-345-28 |
| 61269-735 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MICONAZOLE NITRATE | VW4H1CYW1K | ACTIB |
| MINERAL OIL | T5L8T28FGP | IACT |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| APRICOT KERNEL OIL PEG-6 ESTERS | DRG3KJZ1TJ | IACT |
| WATER | 059QF0KO0R | IACT |
| BUTYLATED HYDROXYANISOLE | REK4960K2U | IACT |
| PEGOXOL 7 STEARATE | 3EW5AXE5X5 | 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 |
|---|---|---|---|---|---|---|
| 07d9b739-ead1-d06a-e063-6294a90a7413 | dc11c03e-3451-c4c0-e053-2a95a90a0d69 | 2023-10-16 | Warnings | dc11c03e-3451-c4c0-e053-2a95a90a0d69 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
