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| Product NDC Code | 68599-0206 | ||||
|---|---|---|---|---|---|
| Drug Name | Antifungal body |
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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 | CREAM | ||||
| RxCUI drug identifier | 998483 | ||||
| Application Number | M005 | ||||
| Labeler Name | McKesson | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Miconazole Nitrate 2%
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 Clean the affected area and dry thoroughly Apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician Supervise children in the use of this product Athlete’s foot Pay special attention to the spaces between toes Wear well-fitting, ventilated shoes and change shoes and socksat least once daily Athlete’s foot and ringworm Use daily for 4 weeks Jock itch Use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on scalp or nails.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Isopropyl Palmitate, Glyceryl Stearate, PEG 100 Stearate, Cyclopentasiloxane, Cetearyl Alcohol, Propylene Glycol, Polyquaternium-37, Propylene Glycol Dicaprylate/Dicaprate, PPG-1 Trideceth-6, Aloe Barbadensis Leaf Juice, Calcium Pantothenate (Vitamin B5), Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCL (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Starch Octenylsuccinate, Tocopherol Acetate (Vitamin E), Lysine, Histidine, Arginine, Aspartic Acid, Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine, Methionine, Isoleucine, Leucine, Tyrosine, Phenylalanine, Cysteine, Triethanolamine, DMDM Hydantoin, Iodopropynyl Butylcarbamate
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 for treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) relieves itching,scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch for treatment ofsuperficial skin infections caused by yeast (Candida albicans)
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.Antifungal Body Miconazole Nitrate 1-BUTENE STEARIC ACID CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) ALANINE GLYCERIN WATER BUTYLATED HYDROXYTOLUENE DIMETHICONE ALOE CALCIUM PANTOTHENATE NIACINAMIDE SILICON DIOXIDE SODIUM ASCORBYL PHOSPHATE ALUMINUM STARCH OCTENYLSUCCINATE .ALPHA.-TOCOPHEROL ACETATE LYSINE ARGININE THREONINE PROLINE GLYCINE VALINE PHENYLALANINE DMDM HYDANTOIN LEUCINE TYROSINE TROLAMINE IODOPROPYNYL BUTYLCARBAMATE ASPARTIC ACID SERINE MALTODEXTRIN PYRIDOXINE HYDROCHLORIDE HISTIDINE GLUTAMIC ACID GLYCERYL MONOSTEARATE ISOPROPYL PALMITATE PEG-100 STEARATE MICONAZOLE NITRATE MICONAZOLE ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) ETHYLENE GLYCOL CETYL ALCOHOL
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.McKesson Thera Antifungal Body Cream Helps treat the most common fungal infections including athlete's foot, jock itch and ringworm. Single Patient Use Therapy [for the skin] Net Contents 4 fl oz (118ml) MFR# 53-AFC4 each
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
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 For External use only. When using this product Do not get into eyes Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks for athlete's foot or ringworm, or within 2 weeks for jock itch. Do not use on children under 2 years of age unless directed by a doctor diaper rash
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