FDA.reportPublic FDA data

Miconazole

Manufacturer
Zennova LLC | 2Y-Biopharma, Ltd.
Effective date
2026-10-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-22 02:02:08

Label at a glance#

ProductMiconazole
Active ingredientMICONAZOLE NITRATE
Label structure10 sections

Indications and uses

For the treatment and prevention of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea capitis). For relief of itching, scaling, cracking, burning and discomfort associated with these conditions.

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 healthcare professional Supervise children in the use of this product. For athlete's foot: Use daily for 4 weeks. If condition persists, consult a healthcare professional. Pay special attention to the spaces between the toes Wear well-fitting, ventilated shoes  Change...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate 2%

PURPOSE

OTC - PURPOSE SECTION

Antifungal

USES

INDICATIONS & USAGE SECTION

  • For the treatment and prevention of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea capitis).
  • For relief of itching, scaling, cracking, burning and discomfort associated with these conditions.

WARNINGS

WARNINGS SECTION

For external use only

Do not use on children less than 2 years of age unless directed by a doctor

OTC - DO NOT USE SECTION

Do not use for diaper rash.

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

DIRECTIONS

DOSAGE & ADMINISTRATION 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 healthcare professional
  • Supervise children in the use of this product.

For athlete's foot: Use daily for 4 weeks. If condition persists, consult a healthcare professional. Pay special attention to the spaces between the toes

  • Wear well-fitting, ventilated shoes  Change socks at least once daily.

For ringworm: Use daily for 4 weeks. If condition persists, consult a healthcare professional.
For jock itch: Use daily for 2 weeks. If condition persists longer, consult a healthcare professional.

  • This product is not effective on the scalp or nails.

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

  • Store at a temperature not exceeding 25°C
  • Close cap tightly after use

TAMPER EVIDENT: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Benzoic Acid, Butylated Hydroxyanisole, Mineral Oil, Oleoyl Polyoxylglycerides, Polyoxyl 7 Stearate, Purified Water

QUESTIONS?

OTC - QUESTIONS SECTION

Call toll free 1-888-572-7085

DISTRIBUTED BY

SPL UNCLASSIFIED SECTION

Zennova LLC.
Princeton, NJ 08540
www.zennova.com

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2% Carton2% Carton2% tube2% tube

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81993-01081993-010-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICONAZOLE NITRATEVW4H1CYW1KACTIB
BENZOIC ACID8SKN0B0MIMIACT
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
MINERAL OILT5L8T28FGPIACT
WATER059QF0KO0RIACT
PEGOXOL 7 STEARATE3EW5AXE5X5IACT
APRICOT KERNEL OIL PEG-6 ESTERSDRG3KJZ1TJIACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 10 · 200 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FGPER ANTIFUNGALMICONAZOLE NITRATEGuangzhou ChuanMa International Trading Co.,Ltd.5ced6af9-f9c4-6e62-e063-6294a90a0e112026-10-03WarningsName fallback
generic name: MICONAZOLE NITRATE
MedlineMICONAZOLE NITRATEMedline Industries, LP0d997d1d-8663-201f-e063-6394a90a285e2026-09-08WarningsName fallback
generic name: MICONAZOLE NITRATE
Remedy Antifungal With OlivamineMICONAZOLE NITRATEMedline Industries, LP28c5183e-05b4-1754-e054-00144ff8d46c2026-09-08WarningsName fallback
generic name: MICONAZOLE NITRATE
Jock Itch PowderMICONAZOLE NITRATEPremier Brands of America Inc5aaacc88-6752-ab47-e063-6394a90af7cd2026-09-04WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole NitrateMICONAZOLE NITRATESun Pharmaceutical Industries, Inc.7fd4037e-d350-47b7-a7d9-a43b8e366fa02026-08-25WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 7MICONAZOLE NITRATEWalgreens0d991104-df96-49b8-b146-67f47b5fcd202026-08-20WarningsName fallback
generic name: MICONAZOLE NITRATE
ClaravieMICONAZOLE NITRATEGentell LLC596d590b-e7ff-4be3-e063-6294a90a871d2026-08-20WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 7MICONAZOLE NITRATEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)0cef9212-201d-4fd2-8afb-ae06ea6b6ee42026-08-20WarningsName fallback
generic name: MICONAZOLE NITRATE
DG Health MiconazoleMICONAZOLE NITRATEDolgencorp Inc12a36975-ebfe-4fcb-a9de-981a213256322026-08-19WarningsName fallback
generic name: MICONAZOLE NITRATE
up and up miconazole 7MICONAZOLE NITRATETarget Corporationb6216f21-4af8-40ab-8151-a9367a42b82c2026-08-18WarningsName fallback
generic name: MICONAZOLE NITRATE
Folliculitis CreamMICONAZOLE NITRATEBeautivity LLC3155dd5e-621b-358e-e063-6294a90a90f82026-08-13WarningsName fallback
generic name: MICONAZOLE NITRATE
FOSTER AND THRIVE MICONAZOLE 1MICONAZOLE NITRATEStrategic Sourcing Services LLC0d3fcb1a-54dd-49b7-b776-4366fc2147b32026-08-12WarningsName fallback
generic name: MICONAZOLE NITRATE
miconazole 1MICONAZOLE NITRATEKroger Company11878a63-93e7-464f-97fc-54899884d7fe2026-08-11WarningsName fallback
generic name: MICONAZOLE NITRATE
topcare miconazole 1MICONAZOLE NITRATETopco Associates LLC8138de63-c7e9-4b2c-a0e2-c62292a0b3202026-08-11WarningsName fallback
generic name: MICONAZOLE NITRATE
MedlineMICONAZOLE NITRATEMedline Industries, LP3c43ef91-bbd2-5e58-e063-6294a90a00d32026-08-05WarningsName fallback
generic name: MICONAZOLE NITRATE
MICONAZOLE 1MICONAZOLE NITRATESafewaybd756451-6f63-4475-9d9a-7fef6a9e5ebf2026-08-03WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 3 Walgreen CompanyMICONAZOLE NITRATEWALGREEN COMPANY32b373be-9c8e-49b0-a796-8d87f6a20cef2026-07-21WarningsName fallback
generic name: MICONAZOLE NITRATE
Antifungal Ringworm Treatment CreamMICONAZOLE NITRATEYunqi Cosmetics (Shenzhen) Co., Ltd56a2ceea-c4c0-c30c-e063-6394a90a0e6a2026-07-15WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 7MICONAZOLE NITRATEPreferred Pharmaceuticals Inc.85a52081-d9cc-44f0-a8d3-851a45c4eb102026-07-08WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 7MICONAZOLE NITRATEPreferred Pharmaceuticals Inc.99c66cbd-7063-4b4c-b827-4f2fcb6ed67f2026-07-08WarningsName fallback
generic name: MICONAZOLE NITRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.