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| Product NDC Code | 52389-600 | ||||
|---|---|---|---|---|---|
| Drug Name | Fungicure intensive |
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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 | LIQUID | ||||
| Application Number | M005 | ||||
| Labeler Name | Alva-Amco Pharmacal Companies, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Clotrimazole 1% 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 Read all package directions and warnings before use. Use only as directed. Clean the affected area with soap and warm water and dry thoroughly. Spray a thin layer of FUNGICURE over the affected area twice daily (morning and night) or as directed by a doctor. This product is not effective on the scalp or nails. Avoid applying to severely cracked or irritated areas. For ringworm and athlete's foot, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. For athlete's foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. Supervise children in the use of this product. Intended for use by normally healthy adults only. Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient Isopropyl alcohol
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 cure of most: ringworm (tinea corporis) athlete's foot (tinea pedis) jock itch (tinea cruris) For relief of: itching scaling cracking burning redness soreness irritation discomforts 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.Fungicure Intensive Clotrimazole ISOPROPYL ALCOHOL CLOTRIMAZOLE CLOTRIMAZOLE
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.FungicureIntensivePDP
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use on children under 2 years of age.
Fungicure Intensive: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.Other information Spray FUNGICURE INTENSIVE on exposed nail-beds, on cuticles, around nail edges and under nail tips. While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use FUNGICURE INTENSIVE until satisfactory results are obtained. You may report serious side effects to the phone number provided under Questions? below.
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? 1-800-792-2582
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.Package Insert Maximum Strength FUNGICURE INTENSIVE Anti-Fungal Treatment Cures Finger and Toe Area Fungal Infections Kills 6 Types of Fungus on Exposed Nail-Beds WHAT IS FUNGUS INFECTION OF THE FINGER AND TOES? Common topical fungus infections of the fingers and toes are caused by a variety of fungi; actual living organisms (members of the yeast and mold family) which thrive in dark, moist conditions. Using small breaches in the skin's surface, these organisms can cause infection by contact with infected surfaces, animals or people. Once infection starts, spreading may occur. For example, infected fingers and toes may infect other fingers and toes. Although such infections often develop slowly, they may be difficult to eliminate if not treated promptly with an effective anti-fungal medicine like FUNGICURE . HOW DO YOU KNOW IF YOU HAVE A TOPICAL FUNGUS INFECTION? Some topical fungal infections may present themselves on the skin surface as ring-like formations with clear centers; this is commonly called ringworm. Athlete's foot fungus and jock itch fungus, when in the finger and toe areas, are often characterized by scaling of skin, burning, cracking, itching, and related discomforts. When nails become infected, they may appear to become opaque (cloudy white), thickened, brittle, easily broken, and in some cases, discolored (greenish/brown). UNDERSTANDING AND TREATING A NAIL AREA INFECTION: Fungal infections of the nail areas are often caused by the same fungi that lead to athlete's foot, jock itch, and ringworm infections elsewhere on the body. These fungi can infect the entire area around the nails including the cuticles, the nail beds, and even the nails themselves. When infected finger/toe nails are intact, over-the-counter topical anti-fungal treatments may not be able to penetrate the nail and kill the fungus; this is why all OTC topical treatments must indicate they are not effective on the nails. However, in instances of advanced infection, the nails often are not not intact; they may be missing, cracked open or lifted away, exposing the infected nail bed. In these instances FUNGICURE Intensive , with its powerful anti-fungal formula, can reach and kill nail bed fungus by direct application or related capillary action. FUNGICURE cures the infection, allowing the natural regrowth of healthy looking tissue. NOTE: Fungal infections which are isolated beneath an intact nail or embedded within the nail itself may require consultation from a doctor for proper treatment. HOW FUNGICURE INTENSIVE WORKS: MAXIMUM STRENGTH FUNGICURE Intensive contains Clotrimazole, a widely recognized anti-fungal ingredient that has been proven to be effective aginst 6 types of fungus such as E. floccosum, T. mentagrophytes, M. canis, M. gypseum, T. tonsurans and T. rubrum. When applied as directed, FUNGICURE Intensive acts promptly to target, destroy, and prevent the spread of infection by inhibiting the growth and reproduction of fungal cells. PROMPT ACTION AND PROPER TREATMENT: Early treatment of fungal infections is important. If you suspect that you may have a fungal infection, consult your doctor promptly for advice and proper diagnosis. You may wish to show him/her FUNGICURE Intensive and discuss its use. For best results, once treatment is started with FUNGICURE Intensive , it is important to carefully follow the treatment instructions on the package until satisfactory results are achieved or advised further by a doctor. NOTE: Noticeable improvement may be expected within 4 weeks in the case of most ringworm (tinea corporis) and athlete's foot (tinea pedis), two weeks for most jock itch (tinea cruris). Consult your doctor for advice if noticeable improvement is not eveident by this time or if condition persists or worsens. Active ingredient: Clotrimazole 1% w/v Uses: For the cure of most: ringworm (tinea corporis) athlete's foot (tinea pedis) jock itch (tinea cruris) For relief of itching scaling cracking burning redness soreness irritation discomforts which may accompany these conditions. Warnings: For external use only. Ask a doctor before use on children under 2 years of age. When using this product avoid contact with the eyes. Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks (2 weeks for jock itch). Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away. Directions: Read all package directions and warnings before use. Use only as directed. Clean the affected area with soap and warm water and dry thoroughly. Spray a thin layer of FUNGICURE over the affected area twice daily (morning and night), or as directed by a doctor. This product is not effective on the scalp or nails. Avoid applying to severely cracked or irritated areas. For ringworm and athlete's foot, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. For athlete's foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. Supervise children in the use of this product. Intended for use by normally healthy adults only. Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor. Other Information: Spray FUNGICURE INTENSIVE on exposed nail-beds, on cuticles, around nail edges and under nail tips. While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use FUNGICURE INTENSIVE until satisfactory results are obtained. You may report serious side effects to the phone number provided under Questions? below. Inactive ingredient: Isopropyl alcohol Questions? 1-800-792-2582 How Supplied: 2 fl. oz. (60ml) non-aerosol pump spray. Storage: Keep container closed (capped) when not in use. Store away from excessive heat or cold. The active ingredient in FUNGICURE has been recognized to be safe and effective by an FDA Expert Advisory Panel, when used as directed.
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 (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.
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