Active Ingredient(S)
Clotrimazole 1%
Ffpmam Antifungal Cream
FDA Label NDC 84558-027
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 Yusong Fine Chemicls Co., Ltd for the product Ffpmam Antifungal Cream (NDC 84558-027). 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 active ingredient(s), purpose, use, warnings, 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
Purpose
Antifungal
Use
●Cures most athlete's foot (tinea pedis), ringworm(tinea corporis)
and jock itch (tinea cruris).●Relieves itching, burning and scaling
Warnings
For external use only.
Do Not Use
Do not use on children under 2 years of age unless direcled
by a doctor.
Otc - When Using
When using this product avoid contact with eyes.
Otc - Stop Use
Stop use and ask a doctor if -lrritation 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
conlact a Poison Control Center right away.
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 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.●lf condition persists longer, consult a doctor.●This
product is not affective on the scalp or nails.
Other Information
Do not use if the carton or inner seal is broken.
Inactive Ingredients
Water, Propylene Glycol, Glycerin, Ethylhexyl Palmitate,Cetyl
Alcohol, Glycery| Stearate, Sorbitan Stearate, Polysorbate 20,
Acrylates/C10-30Alky| Acrylate Crosspolymer, Triethanolamine,
Phenoxyethanol, Ethylhexylglycerin, Aloe Barbadensis Leaf Juice,
Hamamelis Virginiana(Witch Hazel) Extract, Melaleuca Alternifolia
(Tea Tree) Oil, Thymus Vulgaris(Thyme) Extract, Tocopheryl Acetate
Package Label - Principal Display Panel
label
Label (Label)
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