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| Product NDC Code | 46063-552 | ||||
|---|---|---|---|---|---|
| Drug Name | Relispray antifungal powder |
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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 | AEROSOL, SPRAY | ||||
| RxCUI drug identifier | 998428 | ||||
| Application Number | part333C | ||||
| Labeler Name | Midas-Care Pharmaceuticals Pvt. Ltd. | ||||
| 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 wash the affected area and dry thoroughly shake can well and apply a thin layer over the affected area twice daily (morning and night) 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 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe vera, aluminum starch octenyl succinate, isopropyl myristate, propellant (isobutane, normal butane, propane), propylene carbonate, SD alcohol 40-B (10% w/w), sorbitan monooleate, stearalkonium hectorite
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 effectively treats most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) relieves itching, scaling, burning and discomfort which may accompany these conditions
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.Relispray Antifungal Powder Miconazole Nitrate Miconazole Nitrate MICONAZOLE ALOE VERA LEAF ALUMINUM STARCH OCTENYLSUCCINATE Isopropyl Myristate LIQUEFIED PETROLEUM GAS Propylene carbonate ALCOHOL Sorbitan monooleate Stearalkonium hectorite
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.PRINCIPAL DISPLAY PANEL - 128 g Can Label NDC 46063-552-12 Relispray Antifungal Spray Powder Miconazole Nitrate 2% Antifungal Spray Powder Net Wt 4.5 oz (128g) PRINCIPAL DISPLAY PANEL - 128 g Can Label
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 Center 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 or comments? Call 888-491-1965
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) or 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 use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F
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 Flammable. Do not use while smoking or near heat or flame. Do not use on children under 2 years of age unless directed by a doctor When using this product avoid contact with the eyes use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks (for athlete's foot and ringworm) or 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