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| Product NDC Code | 53329-147 | ||||
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| Drug Name | Medline |
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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 | Medline Industries, LP | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Miconazole nitrate 2.0% w/v
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 over affected area twice daily or as directed by a physician supervise use by children 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 four weeks; for jock itch, use daily for two 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 acrylamide/ammonium acrylate copolymer, aloe barbadensis leaf juice, apricot kernel oil PEG-6 esters, ascorbic acid, ascorbyl palmitate, cetyl dimethicone, cholecalciferol, citric acid, citrus aurantium dulcis (orange) peel oil, citrus grandis (grapefruit) peel oil, citrus tangerina (tangerine) peel oil, diazolidinyl urea, ethyl vanillin, glycine, glycine soja (soybean) oil, glycol stearate, hydroxytyrosol, l-proline, l-taurine, methylparaben, methylsulfonylmethane, n-acetyl-l-cysteine, niacinamide, olea europaea (olive) fruit oil, olea europaea (olive) leaf extract, PEG-6 stearate, PEG-8, PEG-32 stearate, polyisobutene, polysorbate 20, propanediol, propylene glycol, propylparaben, pyridoxine HCL, retinyl palmitate, silica, tocopherol, triethanolamine, vanillin, water, zea mays oil
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 the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris) or ringworm (tinea corporis) relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort 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.Medline miconazole nitrate GLYCINE PYRIDOXINE HYDROCHLORIDE GLYCOL STEARATE OLIVE OIL POLYSORBATE 20 METHYLPARABEN DIMETHYL SULFONE NIACINAMIDE CITRUS MAXIMA FRUIT RIND OIL TOCOPHEROL CHOLECALCIFEROL ASCORBYL PALMITATE PROPANEDIOL APRICOT KERNEL OIL PEG-6 ESTERS SOYBEAN OIL POLYISOBUTYLENE (1000 MW) SORBITAN ISOSTEARATE PROPYLENE GLYCOL DIAZOLIDINYL UREA PROPYLPARABEN SILICON DIOXIDE CETYL DIMETHICONE 150 MICONAZOLE NITRATE MICONAZOLE WATER VITAMIN A PALMITATE ACETYLCYSTEINE PEG-32 STEARATE CITRIC ACID MONOHYDRATE PROLINE ETHYL VANILLIN ALOE VERA LEAF POLYETHYLENE GLYCOL 400 PEG-6 STEARATE TROLAMINE TAURINE ORANGE OIL MANDARIN OIL ASCORBIC ACID HYDROXYTYROSOL CORN OIL
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 Label Label V1 RL22WAS
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.Manufacturing Information Manufactured for: Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA Made in USA with domestic and foreign materials www.medline.com 1-800-MEDLINE (633-5463) REF: MSC092604 V1 RL22WAS
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on children under 2 years of age unless directed by doctor
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information protect from freezing avoid excessive heat
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks for athlete’s foot and ringworm there is no improvement within 2 weeks for jock itch
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with the eyes
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 Do not use on children under 2 years of age unless directed by doctor When using this product avoid contact with the eyes Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks for athlete’s foot and ringworm there is no improvement within 2 weeks for jock itch 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