Otc - Active Ingredient
Clotrimazole 1%Antifungal
Kerova Clotrimazole Cream
FDA Label NDC 85959-003
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 Clotrimazole (NDC 85959-003). 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, otc - keep out of reach of children, warnings, indications & usage, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
USES
· Cures most athlete's foot (tinea pedis), ringworm(tinea corporis) and jock itch (tinea cruris)· Relieves itching, burning and scaling
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, getmedical help or contact a Poison Control Center right away.
Warnings
WARNINGSFor external use only.
Indications & Usage
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 well-fitting, ventilated shoes,and change shoes and socks at least once daily.
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.
This product is not effective on the scalp or nails.
Inactive Ingredient
INACTIVE INGREDIENTSWater, Peppermint Oil, Glycerin, Propylene Glycol,Ethylparaben, Dimethicone, Avocado Oil, Cnidium monnieriFruit Extract, Melaleuca alternifolia (Tea Tree) Leaf Oil,Sophora flavescens Root Extract
Package Label.Principal Display Panel
85959-003-01 (85959 003 01)
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