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| Product NDC Code | 68788-8645 | ||||
|---|---|---|---|---|---|
| Drug Name | Antifungal cream |
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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 | Preferred Pharmaceuticals Inc. | ||||
| 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 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 scalp or nails.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Light Mineral Oil, Macrogol Cetostearyl Ether 20, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic Dihydrate, Sodium Phosphate Monobasic Dihydrate, White Petrolatum.
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), Ringworm (tinea corporis). • For the treatment of superficial skin infections caused by yeast (Candida Albicans) • Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet.
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 Cream antifungal EDETATE DISODIUM CETOSTEARYL ALCOHOL LIGHT MINERAL OIL CHLOROCRESOL PROPYLENE GLYCOL WATER WHITE PETROLATUM MICONAZOLE NITRATE MICONAZOLE SODIUM PHOSPHATE, DIBASIC, DIHYDRATE SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE POLYOXYL 20 CETOSTEARYL ETHER
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.2% Miconazole Nitrate Cream, USP Carton 1oz (28.4g) Miconazole Nitrate 2% Cream
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
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 a 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 Centre right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Contact 1-800-707-4621 Manufactured in India by: Gopaldas Visram and Company Limited. Plot No. A327, T.T.C. Indl. Area, M.I.D.C. Mahape, Navi Mumbai - 400710 Mfg. Lic. No.: KD/739 For BluePoint Laboratories Relabeled By: Preferred Pharmaceuticals Inc. NDC 68788-8645-2
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 2 weeks when used for the treatment of jock itch • there is no improvement within 4 weeks when used for athlete's foot and ringworm
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
Storage and handling
Information about safe storage and handling of the drug product.Other information • Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal. • Store at controlled room temperature. • Preserve in tight container. • See crimp of tube or carton for Lot Number and expiry date.
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
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