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| Product NDC Code | 72654-001 | ||||||
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| Drug Name | Fungus master antifungal treatment |
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| Type | Brand | ||||||
| Pharm Class | Azole Antifungal [EPC], Azoles [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LOTION | ||||||
| RxCUI drug identifier | 998521 | ||||||
| Application Number | M005 | ||||||
| Labeler Name | Ebanel Laboratories, Inc | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Miconazole Nitrate 2% Purpose Antifungal
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Wash 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. Store at 15-30°C (59-86°F)
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Ascorbyl Palmitate, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Cinnamomum Zeylanicum Leaf Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Cocos Nucifera (Coconut) Oil, Cymbopogon Flexuosus Oil, Dimethyl Isosorbide, Dodecane, Eucalyptus Globulus Leaf Oil, Eugenia Caryophyllus (Clove) Flower Oil, Glycerin, Lavandula Angustifolia (Lavender) Flower Oil, Leptospermum Scoparium Branch/Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha Piperita (Peppermint) Oil, Oreganum Vulgare Leaf Oil, Panthenol, PEG-12 Dimethicone, PEG-40 Hydrogenated Castor Oil, PEG-8 Dilaurate, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Phospholipids, Polysorbate 20, Polysorbate 60, PPG-26-Buteth-26, Punica Granatum Seed Extract, Retinyl Palmitate, Salicylic Acid, Santalum Spicatum Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Benzoate, Sodium Bicarbonate,Tocopheryl Acetate,Undecylenic Acid, Inact ive Ingredients Urea, Water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Proven clinically effective in the treatment of most athlete’s foot(Tinea Pedis), jock itch(Tinea Cruris) and ringworm(Tinea Corporis). For effective relief of itching, scaling, cracking, burning, redness, Soreness, irritation, discomfort, itchy, scaly skin between the toes, and chafing associated with jock itch.
Purpose
Information about the drug product’s indications for use.Purpose Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.Fungus Master Antifungal Treatment MICONAZOLE NITRATE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) ARGININE ASCORBYL PALMITATE SAFFLOWER OIL CETOSTEARYL ALCOHOL CINNAMON LEAF OIL ORANGE OIL COCONUT OIL EAST INDIAN LEMONGRASS OIL DIMETHYL ISOSORBIDE DODECANE EUCALYPTUS OIL CLOVE OIL GLYCERIN MANUKA OIL TEA TREE OIL PEPPERMINT OIL PANTHENOL PEG-12 DIMETHICONE POLYOXYL 40 HYDROGENATED CASTOR OIL PEG-8 DILAURATE AVOCADO OIL PHENOXYETHANOL LECITHIN, SOYBEAN POLYSORBATE 20 POLYSORBATE 60 PPG-26-BUTETH-26 POMEGRANATE SEED VITAMIN A PALMITATE SALICYLIC ACID JOJOBA OIL SODIUM BENZOATE SODIUM BICARBONATE .ALPHA.-TOCOPHEROL ACETATE UNDECYLENIC ACID UREA WATER MICONAZOLE NITRATE MICONAZOLE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package Labeling: 1 2 3
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.DRUG FACTS
Other Information Functional ingredients used in this formula have been shown to improve the appearance of thickened, discolored, and unhealthylooking feet caused by dermatophytic fungi. Urea has been shown to thin, soften, and act as penetrating agent on skin. Undecylenic acid is effective as an emulsifier, cleanser, and preservative.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Do not use on children under 2 years of age. For external use only. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 4 weeks (for athlete’s foot and ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API