MedPath

Kerova Miconazole Nitrate

Approved
Approval ID

3b8b5547-f8d1-9e48-e063-6294a90af429

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 4, 2025

Manufacturers
FDA

Guangzhou Bixiaoyu Trading Co., Ltd.

DUNS: 511381369

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Miconazole Nitrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85959-001
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Miconazole Nitrate
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 4, 2025
FDA Product Classification

INGREDIENTS (11)

ETHYLPARABENInactive
Code: 14255EXE39
Classification: IACT
AVOCADO OILInactive
Code: 6VNO72PFC1
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILInactive
Code: VIF565UC2G
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SOPHORA FLAVESCENS ROOTInactive
Code: IYR6K8KQ5K
Classification: IACT
MICONAZOLE NITRATEActive
Quantity: 2 g in 100 g
Code: VW4H1CYW1K
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CNIDIUM MONNIERI FRUITInactive
Code: V1IA3S3CUS
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/10/2025

labeling

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/10/2025

DIRECTIONS
"Clean the affected area and dry thoroughly.
*Apply a thin layer of the product over affected area twicedaily (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 spacesbetween the toes; wear wellfitting, 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 persists longer, consult a doctor.
.This product is not effective on the scalp or nails.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/10/2025

Miconazole Nitrate 2% Antifungal

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/10/2025

Cures most athlete's foot (tinea pedis),

ringworm(tinea corporis) and jock itch (tinea cruris),

Relieves itching, burning and scaling

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/10/2025

Water, Peppermint Oil, Glycerin, Propylene Glycol,
Ethylparaben, Dimethicone, Avocado Oil, Cnidium monnieri
Fruit Extract, Melaleuca alternifolia (Tea Tree) Leaf Oil,
Sophora flavescens Root Extract

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/10/2025

Keep out of reach of children.lf swallowed, getmedical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/10/2025

Stop use and ask a doctorif ,lrritation occurs.

"There is no improvement within 4 weeks for athlete'sfoot and ringworm, or within 2 weeks for jock itch.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/10/2025

WARNINGS

For external use only.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 8/10/2025

OTHER INFORMATION

Store between 20° to 30°C (68° to 86°F)

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/10/2025

Do not use on children under 2 years of age unlessdirected by a doctor.

WARNINGS SECTION

LOINC: 34071-1Updated: 8/10/2025

For external use only

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/10/2025

"For athlete's foot and ringworm, use daily for 4 weeks.
For jock itch, use daily for 2 weeks.
’If condition persists longer, consult a doctor.

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Kerova Miconazole Nitrate - FDA Drug Approval Details