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
- Chain Drug Consortium, LLC
- Effective date
- 2025-06-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 12
- Source
- full-release
- Hydrated at
- 2026-06-01 01:06:01
Label at a glance#
ProductMiconazole
Active ingredientMICONAZOLE NITRATE
Label structure10 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 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 j...
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 (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 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
Principal display panel
COMPARE TO THE ACTIVE INGREDIENT IN MICARIN® ANTIFUNGAL CREAM*
Antifungal Cream
Miconazole nitrate cream, USP 2%
Cures Most
Athlete's Foot,
Jock Itch & Ringworm.
Soothes Itching, Scaling, Cracking, and Burning
*This product is not manufactured or distributed by WellSpring Pharmaceutical Corporation, distributor of Micatin® Antifungal Cream.
Distributed By: Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087
Package label
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68016-291-01 | Miconazole | 1 in 1 CARTON | CREAM | 1 | 12 | |
| 68016-291-01 | Miconazole | 28 g in 1 TUBE | CREAM | 28 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68016-291-01 | GM - Gram | 68016-291 | 1e8b2dde-5c7f-4ebb-af84-ceea0b380a21 | 1 | 2022-06-06 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MICONAZOLE NITRATE | ACTIVE INGREDIENT | VW4H1CYW1K | 4 | |
| MICONAZOLE | ACTIVE MOIETY | 7NNO0D7S5M | 4 | |
| BENZOIC ACID | INACTIVE INGREDIENT | 8SKN0B0MIM | 4 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | 4 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 4 | |
| PEG-5 OLEATE | INACTIVE INGREDIENT | 0240V77G50 | 4 | |
| PEGOXOL 7 STEARATE | INACTIVE INGREDIENT | 3EW5AXE5X5 | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 4 |
Products#
Every source-derived product name is available through these pages.
- Miconazole
- Miconazole Nitrate
- BENZOIC ACID
- BUTYLATED HYDROXYANISOLE
- MINERAL OIL
- PEGOXOL 7 STEARATE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68016-291 | 68016-291-01 |
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#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | CREAM / TOPICAL | 2 mg | ||
| PEG-5 OLEATE | PEG-5 OLEATE | 0240V77G50 | CREAM / TOPICAL | 98 mg | ||
| PEGOXOL 7 STEARATE | PEGOXOL 7 STEARATE | 3EW5AXE5X5 | CREAM / TOPICAL | 640 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | CREAM / TOPICAL | 6 mg | ||
| PEGOXOL 7 STEARATE | PEGOXOL 7 STEARATE | 3EW5AXE5X5 | CREAM / TOPICAL | 640 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / TOPICAL | 2772 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | CREAM / TOPICAL | 6 mg | ||
| PEG-5 OLEATE | PEG-5 OLEATE | 0240V77G50 | CREAM / TOPICAL | 98 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / TOPICAL | 2772 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | CREAM / TOPICAL | 2 mg |
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 |
|---|---|---|---|---|---|---|
| Miconazole | MICONAZOLE NITRATE | Chain Drug Consortium, LLC | 246be926-79ea-4e0c-a3ef-2aa7fc3a52bf | 2025-06-30 | Warnings | 68016-291-01 68016-291 68016029101 421e11c4-085b-4f3d-bbbc-079d4ea522fc 246be926-79ea-4e0c-a3ef-2aa7fc3a52bf |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.