Search by Drug Name or NDC
NDC 72189-0345-28 MICONAZOLE NITRATE 20 mg/g Details
MICONAZOLE NITRATE 20 mg/g
MICONAZOLE NITRATE is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by DirectRx. The primary component is MICONAZOLE NITRATE.
MedlinePlus Drug Summary
Topical miconazole is used to treat tinea corporis(ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), and tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes). Miconazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection. Not all products should be used to treat all of these conditions. Please read the label for each product to select the one to treat your condition.
Related Packages: 72189-0345-28Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Miconazole Topical
Product Information
| NDC | 72189-0345 |
|---|---|
| Product ID | 72189-345_dc11c03e-3452-c4c0-e053-2a95a90a0d69 |
| Associated GPIs | 90154050103705 |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | MICONAZOLE NITRATE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | MICONAZOLE NITRATE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/g |
| Substance Name | MICONAZOLE NITRATE |
| Labeler Name | DirectRx |
| Pharmaceutical Class | Azole Antifungal [EPC], Azoles [CS] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part333C |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 72189-0345-28 (72189034528)
| NDC Package Code | 72189-345-28 |
|---|---|
| Billing NDC | 72189034528 |
| Package | 28 g in 1 BOTTLE (72189-345-28) |
| Marketing Start Date | 2022-04-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL dc11c03e-3451-c4c0-e053-2a95a90a0d69 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED 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.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED 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
INGREDIENTS AND APPEARANCE
| MICONAZOLE NITRATE
miconazole nitrate cream |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
| Labeler - DirectRx (079254320) |
| Registrant - DirectRx (079254320) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| DirectRx | 079254320 | relabel(72189-345) | |