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 Cream, USP
- Manufacturer
- A-S Medication Solutions
- Effective date
- 2021-02-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-05-31 23:37:57
Label at a glance#
ProductAntifungal
Active ingredientMICONAZOLE NITRATE
Label structure10 sections
Dosage and administration
wash 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 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 jo...
Contacts and useful links#
Label contents#
Full prescribing information#
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
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 right away.
Directions
- wash 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 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
- store at controlled room temperature 59°-86°F (15°-30°C).
- 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?
1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.
HOW SUPPLIED
Product: 50090-2718
NDC: 50090-2718-0 28 g in a TUBE / 1 in a CARTON
miconazole nitrate
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| MICONAZOLE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 3a55f4fb-5aec-4c88-0ff7-4d608ad4866a | Product name | 1 | 20140508 |
| 5b9a7965-36d2-8412-dcaf-f76a65411611 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-2718-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-fbbf-0266-e053-dadaa90a7c1a | Miconazole Nitrate Cream, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-2718-0 | Antifungal | 28 g in 1 TUBE | CREAM | 28 | 7 | |
| 50090-2718-0 | Antifungal | 1 in 1 CARTON | CREAM | 1 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-2718 | ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [A-S MEDICATION SOLUTIONS] | 7 | Legacy NDC, 2 package rows | 20210211_197ee41f-4faa-4251-8c86-1669d5e0b443.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-2718-0 | GM - Gram | 50090-2718 | 4dee5b95-4889-4247-9dbe-c3563c931513 | 1 | 2019-04-11 |
| 0472-0735-14 | GM - Gram | 0472-0735 | f296107a-ec2d-4ac6-856c-9be7c31a64f2 | 1 | 2013-02-13 |
| 0472-0735-42 | GM - Gram | 0472-0735 | 71184119-c239-45b1-bce9-4d7af04d60e0 | 1 | 2013-02-13 |
| 0472-0735-56 | GM - Gram | 0472-0735 | 761b319f-8792-4e07-8364-da08d0cc556e | 1 | 2013-02-13 |
Products#
Every source-derived product name is available through these pages.
- Antifungal
- Miconazole Nitrate
- MICONAZOLE
- BENZOIC ACID
- BUTYLATED HYDROXYANISOLE
- MINERAL OIL
- PEGOXOL 7 STEARATE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50090-2718 | 50090-2718-0 |
| 0472-0735 |
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 |
| 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 |
|---|---|---|---|---|---|---|
| 265367bf-571e-4cf0-ab12-278f4e874fc0 | 197ee41f-4faa-4251-8c86-1669d5e0b443 | 2021-02-09 | Warnings | 265367bf-571e-4cf0-ab12-278f4e874fc0 197ee41f-4faa-4251-8c86-1669d5e0b443 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.