Indications and uses
treats most athlete’s foot, jock itch and ringworm relieves itching, scaling, burning, irritation and discomfort
treats most athlete’s foot, jock itch and ringworm relieves itching, scaling, burning, irritation and discomfort
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 this product does not work on the scalp or nails 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 every day For athle...
Miconazole nitrate 2%
Antifungal
For external use only
Do not use on children under 2 years, unless directed by a doctor.
If swallowed, get medical help or contact a Poison Control Center right away.
For athlete’s foot
For athlete’s foot and ringworm
For jock itch
Store at room temperature 59º - 86ºF (15º - 30ºC).
IMPORTANT: The opening of this product is covered by a metal tamper-evident seal. If this seal has been punctured or is not visible, do not use and return product to place of purchase.
TO OPEN: To puncture the seal, reverse the cap and place the puncture-top onto the tube. Push firmly until seal is open. To close, screw the cap back onto the tube.
Benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water
NDC 54868-2471-0
Compare to the active ingredient in Micatin® Antifungal Cream*
Actavis
Antifungal Cream
Miconazole Nitrate 2%
Relieves Burning, Cures Most Athlete’s Foot, Jock Itch, Ringworm
Net wt. 14 g tube cream
07350200D1 VC106266
| Class | Version | Type | Effective |
|---|---|---|---|
| MICONAZOLE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54868-2471-0 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3f1a-c013-e053-90daa90a1393 | Miconazole Nitrate Antifungal Cream |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54868-2471-0 | Miconazole Nitrate | 1 in 1 CARTON | CREAM | 1 | 2 | |
| 54868-2471-0 | Miconazole Nitrate | 14 g in 1 TUBE | CREAM | 14 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54868-2471 | MICONAZOLE NITRATE CREAM [PHYSICIANS TOTAL CARE, INC.] | 2 | 2 package rows | 20121106_1ff4dcb5-d4ac-4e4b-a1ae-993f28939942.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 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 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MICONAZOLE NITRATE | ACTIVE INGREDIENT | VW4H1CYW1K | 2 | |
| MICONAZOLE | ACTIVE MOIETY | 7NNO0D7S5M | 2 | |
| BENZOIC ACID | INACTIVE INGREDIENT | 8SKN0B0MIM | 2 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | 2 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 54868-2471 | 54868-2471-0 |
| 0472-0735 |
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 |
| WATER | 059QF0KO0R | IACT |
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 |
|---|---|---|---|---|---|---|
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | CONCENTRATE / ORAL | 12.5 mg/5ml | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | FILM, EXTENDED RELEASE / TRANSDERMAL | 34 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | AEROSOL, FOAM / VAGINAL | 0.1 %w/w | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | MOUTHWASH / BUCCAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | DROPS / ORAL | NA | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | CREAM / VAGINAL | 10 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | FILM / TRANSDERMAL | 11.42 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SOAP / TOPICAL | 0.82 %w/w | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | CREAM / TOPICAL | 2 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OIL / TOPICAL | 43.29 %v/v | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | INJECTION / INTRAVENOUS | 5 %w/v | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | INJECTION / INTRAVENOUS | NA | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | GRANULE, FOR SUSPENSION / ORAL | NA | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | CREAM / TOPICAL | 6 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE / ORAL | 120 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / VAGINAL | 402 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | AEROSOL, FOAM / TOPICAL | 1 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, COATED / ORAL | 1.5 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | SUPPOSITORY / VAGINAL | 1 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / DENTAL | 95 %w/w | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | CAPSULE / ORAL | 4 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, DELAYED RELEASE / ORAL | 5.67 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / AURICULAR (OTIC) | 0.5 %w/v | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | SUPPOSITORY / RECTAL | 1 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / TOPICAL | 9938 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | ELIXIR / ORAL | 90 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | TABLET, FILM COATED / ORAL | NA | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SYRUP / ORAL | 20 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / AURICULAR (OTIC) | NA | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | CREAM / VAGINAL | 0.03 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET / ORAL | 113.75 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SUPPOSITORY / VAGINAL | 2 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | OINTMENT / TOPICAL | 0.01 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / OPHTHALMIC | 59.5 %w/w | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | GEL / RECTAL | 11 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / TOPICAL | 82 %w/w | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | CAPSULE, LIQUID FILLED / ORAL | 4 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | GEL / TOPICAL | 2.5 %w/w | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | GEL / TOPICAL | 0.1 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, FILM COATED / ORAL | NA | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | INJECTION, SOLUTION / INTRAMUSCULAR | 0.2 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SOLUTION / IRRIGATION | 0.02 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, CHEWABLE / ORAL | 6 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | CONCENTRATE / ORAL | 0.08 mg/1ml | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET, FILM COATED / ORAL | 0.4 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / VAGINAL | 30 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET / SUBLINGUAL | 2 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TRANSDERMAL | 6.09 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | LOTION / TOPICAL | 1428 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SPRAY / TOPICAL | 1379 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / RECTAL | NA | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | LIQUID / ORAL | 2 mg/1ml | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | INJECTION / INTRAMUSCULAR | 5 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / TOPICAL | 47.5 %w/w | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SOLUTION / TOPICAL | 0.1 %w/w | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | SOLUTION / ORAL | 5 mg |
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 |
|---|---|---|---|---|---|---|
| 52c919c0-4f65-4ed0-9a6d-5fb44d32b39e | 1ff4dcb5-d4ac-4e4b-a1ae-993f28939942 | 2012-11-05 | Warnings | 52c919c0-4f65-4ed0-9a6d-5fb44d32b39e 1ff4dcb5-d4ac-4e4b-a1ae-993f28939942 |
Adverse event summaries are temporarily unavailable. Other product information remains available.