Otc - Active Ingredient
Miconazole Nitrate 2% Antifungal
Kerova Miconazole Nitrate Cream
FDA Label NDC 85959-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Bixiaoyu Trading Co., Ltd. for the product Kerova Miconazole Nitrate (NDC 85959-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, inactive ingredient, otc - keep out of reach of children, otc - stop use, otc - when using, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Cures most athlete's foot (tinea pedis),
ringworm(tinea corporis) and jock itch (tinea cruris),
Relieves itching, burning and scaling
Indications & Usage
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.
Inactive Ingredient
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
Keep out of reach of children.lf swallowed, getmedical help or contact a Poison Control Center right away.
Otc - Stop Use
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
WARNINGS
For external use only.
Other Safety Information
OTHER INFORMATION
Store between 20° to 30°C (68° to 86°F)
Otc - Do Not Use
Do not use on children under 2 years of age unlessdirected by a doctor.
Warnings
For external use only
Dosage & Administration
"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.
Package Label.Principal Display Panel
Labeling (85959 001 01)
* Please review the disclaimer below.
