Otc - Active Ingredient
Mioonazole Nitrate 2%
Antifungal Cream
FDA Label NDC 87278-021
11 label sections · Submitted to the FDA by Guangxi Keyun E-commerce Co., Ltd. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangxi Keyun E-commerce Co., Ltd. for the product Antifungal Cream (NDC 87278-021). 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, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal
Indications & Usage
Cures most athlete's foot (tinea pedis), ningworm(tinea corporis) and jock itch (tinea cruris) +
Relieves itching, burning and scaling
Warnings
For externaluse only.
Otc - Do Not Use
Do not use on children under 2 years of age unless directed by a doctor.
Otc - When Using
When using this product avoid contact with eyes.
Otc - Stop Use
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Clean the affected area and dry thoroughly.
Apply a thin layer of the product over affected area twice daily (moning and night) or as directed by a doctor.
Supervise children in the use of this product.
For athlete's foot: Pay special attention to 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 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
Cridiummoner Fruit Extract
Melaleuca Alternifolia (Tea Tree) Leaf Oil
Sophora Flavescens Root Extract
Package Label.Principal Display Panel
Label1 (Label)
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