Indications and uses
for the cure of most athlete's foot, jock itch and ringworm
Miconazole Nitrate
- Manufacturer
- Topco Associates LLC
- Effective date
- 2024-11-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 00:35:18
Label at a glance#
ProductMiconazole Nitrate
Active ingredientMICONAZOLE NITRATE
Label structure9 sections
Dosage and administration
clean the affected area and dry thoroughly apply a thin layer of 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 i...
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
Miconazole nitrate 2%
Purpose
Antifungal
Uses
for the cure of most athlete's foot, jock itch and ringworm
Warnings
For external use only.
Do not use
on children 2 years of age unless directed by a doctor.
When using this product
avoid contact with the eyes
Stop and ask a doctor if
irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks for jock itch.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor.
Directions
- clean the affected area and dry thoroughly
- apply a thin layer of 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 conditions persist longer, consult a doctor
- this product is not effective on the scalp or nails
Other information
- store between 59º - 86ºF
- lightly shake bottle to loosen settled powder
Inactive ingredients
allantoin, chloroxylenol, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalicum phosphate, zea mays (corn) starch
Questions?
call 1-866-964-0939
Principal Display Panel
TopCare
health
Miconazorb AF
ANTIFUNGAL POWDER
MICONAZOLE NITRATE 2%
- Cures Most Athlete's Foot, Jock Itch & Ringworm
- Relieves Chafing, iIching, Burning & Scaling
- Absorbs Moisture
- Talc-Fee
NET WT 2.5 OZ (71g)
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 |
|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 36800-385-25 | 2023-01-31 | C162847 | 48780-1 | f386c64a-0209-0266-e053-dadaa90a7c1a | Topcare Miconazorb Anti Fungal Powder Talc Free |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-385-25 | Miconazole Nitrate | 71 g in 1 BOTTLE, PLASTIC | POWDER | 71 | 7 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 36800-385-25 | GM - Gram | 36800-385 | e5547636-3587-4e2a-ac8e-4883fce6745c | 1 | 2024-04-05 |
Products#
Every source-derived product name is available through these pages.
- Miconazole Nitrate
- Anti-fungal Powder Miconazole Nitrate Talc Free
- ALLANTOIN
- CHLOROXYLENOL
- IMIDUREA
- MICROCRYSTALLINE CELLULOSE
- TRICALCIUM PHOSPHATE
- ZEA MAYS SUBSP. MAYS WHOLE
- MICONAZOLE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 36800-385 | 36800-385-25 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALLANTOIN | 344S277G0Z | IACT |
| CHLOROXYLENOL | 0F32U78V2Q | IACT |
| IMIDUREA | M629807ATL | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| TRICALCIUM PHOSPHATE | K4C08XP666 | IACT |
| ZEA MAYS SUBSP. MAYS WHOLE | 1G5HNE09V8 | IACT |
| MICONAZOLE NITRATE | VW4H1CYW1K | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Miconazole Nitrate | ANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREE | Topco Associates LLC | 0afaf920-e30a-4a7c-a19e-558b31ae7e58 | 2024-11-07 | Warnings | 36800-385-25 36800-385 36800038525 2655afa6-4595-89ba-e063-6394a90a22c5 0afaf920-e30a-4a7c-a19e-558b31ae7e58 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.