Active Ingredient(S)
Miconazole Nitrate 2%
2% Miconazole Nitrate Antifungal Cream
FDA Label NDC 84558-025
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 2% Miconazole Nitrate Antifungal Cream (NDC 84558-025). 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
Treats athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm
(tinea corporis).Relieves itching, scaling, burning and discomfort.
Warnings
For external use only. Avoid contact with eyes. Do not use on children
under 2 years of age unless directed by a doctor. Do not use for vaginal
yeast infections.
Ask a doctor before use if you have diabetes, immune system problems,
or a condition covering more than half the affected area.
Stop use and ask a doctor if irritation occurs, condition worsens, or there
is no improvement within 2 weeks (jock itch) or 4 weeks (athlete's
foot /ringworm).
Keep out of reach of children. If swallowed, get medical help or contact
Poison Control right away.
Do Not Use
Do not use on children under 2 years of age unless directed by a doctor.
Do not use for vaginal yeast infections.
Otc - When Using
avoid contact with eyes
do not apply to irritated or broken skin
use only as directed
Otc - Stop Use
Stop use and ask a doctor if irritation occurs, condition worsens, or there
is no improvement within 2 weeks (jock itch) or 4 weeks (athlete's
foot /ringworm).
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact
Poison Control right away.
Directions
Clean and dry the affected area thoroughly. Apply a thin layer twice daily (morning and night).
Athlete's foot /ringworm: use for 4 weeks.
Jock itch: use for 2 weeks.
Supervise children during use; wear well-ventilated shoes and change socks daily for athlete's foot.
Other Information
Store at 20°-25C(68°-77°F). Do not use if carton or inner seal is broken.
Inactive Ingredients
Water, Glycerin, Caprylic/Capric Triglyceride, Propylene Glycol,Stearic
Acid, C12-15Alkyl Benzoate, Glyceryl Stearate,Cetyl Alcohol,
Dimethicone, Phenoxyethanol, Squalane, PEG-100 Stearate,
Triethanolamine, Panthenol, Centella Asiatica Extract, Camellia Sinensis
Leaf Extract, Curcuma Longa Root Extract,Sophora Flavescens Root
Extract, Phellodendron Amurense Bark Extract, Pseudolarix Amabilis Root
Bark Extract,Kochia Scoparia Fruit Extract,Eugenia Caryophyllus (Clove)
Bud Extract, Melaleuca Alternifolia Leaf Oil, Allantoin,Carbomer,Bisabolol,
Beta-Glucan,Aloe Barbadensis Leaf Juice,Tocopheryl Acetate,
Ethylhexylglycerin, Disodium EDTA,Ceramide NP
Package Label - Principal Display Panel
Undefined (Label)
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