Otc - Active Ingredient
Active Ingredient: Miconazole Nitrate 2%
Fungus Master Lotion
FDA Label NDC 63742-098
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Clinical Resolution Laboratory, Inc. for the product Fungus Master (NDC 63742-098). 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, dosage & administration, warnings, indications & usage, otc - keep out of reach of children, inactive ingredient, otc - purpose, 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
Dosage & Administration
Directions
Clean the affected area and dry thoroughly. Apply a thin layer of the product 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. 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.
Warnings
Warnings
■ Do not use on children under 2 years of age unless directed by a doctor.
■ For external use only.
■ Avoid contact with the eyes.
■ If irritation occurs or if there is no improvement within 4 weeks for the treatment of athlete's foot and ringworm, or 2 weeks for the treatment of jock itch, discontinue use and consult a doctor.
Indications & Usage
Uses
■ Proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
Otc - Keep Out Of Reach Of Children
Other Information
■ Shake well before use.
■ Keep away from direct sunlight or heat. Store at room temperature 15°-30°C (59°-86°F).
■ Keep out of reach of children.
■ In case of accidental overdose or ingestion, call a doctor or poison control center immediately.
■ Do not use this product if seal is broken or missing.
Inactive Ingredient
Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine HCl, Ascorbyl Palmitate, Butyrospermum Parkii (Shea) Butter, Caprylyl Glycol, Cetearyl Alcohol, Cinnamomum Zeylanicum Leaf Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Cocos Nucifera (Coconut) Oil, Cymbopogon Flexuosus Oil, Dimethyl Isosorbide, Disodium EDTA, Dodecane, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Eugenia Caryophyllus (Clove) Bud Oil, Fusanus Spicatus Wood (Sandalwood) Oil, Glycerin, Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lavandula Angustifolia (Lavender) Oil, Leptospermum Scoparium Branch/Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha Piperita (Peppermint) Oil, Origanum Vulgare (Oregano) Leaf Oil, Panthenol, PEG-12 Dimethicone, PEG-4 Dilaurate, PEG-40 Hydrogenated Castor Oil, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Phospholipids, Polysorbate 20, Polysorbate 60, PPG-26-Buteth-26, Retinyl Palmitate, Salicylic Acid, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Benzoate, Sodium Bicarbonate, Squalane, Tocopheryl Acetate, Triethanolamine, Undecylenic Acid, Urea, Water, Xanthan Gum
Otc - Purpose
Purpose…………………………………….. Antifungal
Package Label.Principal Display Panel
Fungus Master 2 Oz (Otc Fungusmaster 2oz Vr3)
Fungus Master_1 Oz (Otc Fungusmaster 1oz Vr3)
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