Otc - Active Ingredient
Active ingredient
Miconazole Nitrate 2%
PurposeAntifungal
Fgper Antifungal Cream
FDA Label NDC 85593-140
7 label sections · Submitted to the FDA by Guangzhou Chuanma International Trading Co.,ltd. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Chuanma International Trading Co.,ltd. for the product Fgper Antifungal (NDC 85593-140). 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, indications & usage, dosage & administration, inactive ingredient, warnings, 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
treats most athlete's foot (tinea pedis), jockitch (tinea cruris), and ringworm(tinea corporis)relieves itching, scaling, cracking, burning,redness, soreness, irritation, and discomfortassociated with these conditions
Otc - Keep Out Of Reach Of Children
Keep outofreach of children.If swallowed, get medical help or contact aPoison Control Center right away.
Indications & Usage
Stop use and askadoctor
if irritation occurs or if there is no improvement within 4 weeks for athlete's foot and ringworm-irritation occurs or if there is no improvementwithin 2 weeks for jock itch
Dosage & Administration
clean the affected area and drythoroughlyapplya thin layer of the product over affected area twicedaily (moming and night) or asdirected byadoctorsupervise children in the use of this productforathlete'sfoot: pay specialattention to spacesbetween the toes; wear well-fitting,ventilatedshoes, and change shoes and socks at leastoncedaily
for athlete's foot and ringworm, use dailyfor4weeks; forjock itch, use daily for 2 weeks if condition persists longer, consult a doctor thisproductis noteffective on the scalp ornails
Inactive Ingredient
Water, Allantoin, CetearylAlcohol, Squalane,Ceteareth-6, Ceteareth-25, C12-15 AlkylBenzoate, Glyceryl Stearate, PEG-100 Stearate,Dimethicone, Ethylhexyl Palmitate, Bisabolol,Carbomer, Menthol, Panthenol, Propylene Glycol,Triethanolamine, Aloe Barbadensis Leaf Extract,Ceramide, Melaleuca Alternifolia (Tea Tree) LeafOil, Imidazolidinyl Urea.
Warnings
Warnings: For external use only.
Donotusebyadoctor
ยท on children under 2 years of age unless directed
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