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| Product NDC Code | 0536-1375 | ||||
|---|---|---|---|---|---|
| Drug Name | Miconazole nitrate 2% cream antifungal |
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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 | part333C | ||||
| Labeler Name | Rugby | ||||
| 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%
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 healthcare professional • Supervise children in the use of this product. For athlete's foot: • Use daily for 4 weeks. If condition persists, consult a doctor • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks at least once daily. For ringworm: Use daily for 4 weeks. If condition persists, consult a doctor. 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Carbomer, alcohol, cetostearyl alcohol, dimethyl sulfoxide, edetate disodium, ethylparaben, glycerol, mineral oil, mono and di glycerides, polyoxyethylene lauryl ether, purified water, stearic acid, triethanolamine, 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 proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) relieves itching, scaling, cracking, burning and discomfort associated with these conditions.
Purpose
Information about the drug product’s indications for use.Purpose Anti-Fungal
Spl product data elements
Usually a list of ingredients in a drug product.MICONAZOLE Nitrate 2% Cream ANTIFUNGAL MICONAZOLE NITRATE CETOSTEARYL ALCOHOL DIMETHYL SULFOXIDE EDETATE DISODIUM ETHYLPARABEN GLYCERIN MINERAL OIL LAURETH-30 WATER STEARIC ACID TROLAMINE PETROLATUM MICONAZOLE NITRATE MICONAZOLE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE GLYCERYL MONO AND DIPALMITOSTEARATE 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.Packaging Rugby Miconazole Cream 1oz CDER
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 Distributed by: Rugby Laboratories Indianapolis, IN. 46268 800-616-2471 www.majorpharmaceuticals.com This product is not manufactured or distributed by Wellspring Pharmaceutical Corporation owner of the registered trademark Micatin.
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 (1-800-222-1222) immediately.
Storage and handling
Information about safe storage and handling of the drug product.Other Information • Store at 15° - 30° c (59° - 86° f) • Lot number and expiration date see crimp of tube or see box. • To open: Unscrew cap, tear safety seal off.
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 if the safety-sealed tube is punctured or damaged. Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with the eyes. Stop use and ask a doctor if • irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm) • Irritation occurs, or if there is no improvement within 2 weeks (for jock itch).
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