Otc - Active Ingredient
Miconazole nitrate 2%
Antifungal Ringworm Treatment Cream
FDA Label NDC 84763-014
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yunqi Cosmetics (shenzhen) Co., Ltd for the product Antifungal Ringworm Treatment Cream (NDC 84763-014). 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 jock itch, ringworm, and athlete's foot. Relieves itching, burning,cracking, and scaling which accompany these conditions.
Warnings
For external use only
Otc - Do Not Use
on children under 2 years of age unless directed by a doctor
on open wounds or broken skin
on the scalp or nails
Otc - When Using
avoid contact with the eyes. If contact occurs rinse eyes thoroughly with water.
do not use more than directed unless told to do so by a doctor
Otc - Stop Use
irritation occurs
there is no improvement within 4 weeks
condition worsens or clears up and occurs again within a few days
Otc - 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 over affected area twice daily 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 spaces between the toes:wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
use daily for 4 weeks
if condition persists, ask a doctor
Inactive Ingredient
Water
Glycerin
Propylene Glycol
Mineral Oil
Cetearyl Alcohol
Glyceryl Stearate
Ceramide
Squalane
Panthenol (Vitamin B5)
PEG-100 Stearate
Dimethicone
Stearic Acid
Allantoin
Carbomer
Aloe Barbadensis Leaf Extract
Centella Asiatica Extract
Glycyrrhiza Glabra (Licorice) Root Extract
Chamomilla Recutita (Matricaria) Flower Extract
Melaleuca Alternifolia (Tea Tree) Leaf Oil
Phenoxyethanol
Triethanolamine
Tocopherol
Ethylhexylglycerin
Menthol
Package Label.Principal Display Panel
Label2 (Label2)
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