Fungicure Liquid Gel
Clotrimazole
Alva-amco Pharmacal Companies, Inc.
Human Otc Drug
NDC 52389-733Fungicure Liquid Gel also known as Clotrimazole is a human otc drug labeled by 'Alva-amco Pharmacal Companies, Inc.'. National Drug Code (NDC) number for Fungicure Liquid Gel is 52389-733. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Fungicure Liquid Gel drug includes Clotrimazole - 10 mg/g . The currest status of Fungicure Liquid Gel drug is Active.
Drug Information:
| Drug NDC: | 52389-733 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Fungicure Liquid Gel |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Clotrimazole |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Alva-amco Pharmacal Companies, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CLOTRIMAZOLE - 10 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 31 Dec, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part333C |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Alva-Amco Pharmacal Companies, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1049535
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0072959015336
|
| UPC stands for Universal Product Code. |
| NUI: | N0000175487
M0002083
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | G07GZ97H65
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Azole Antifungal [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Azoles [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Azole Antifungal [EPC]
Azoles [CS]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 52389-733-09 | 1 TUBE, WITH APPLICATOR in 1 BOX (52389-733-09) / 9 g in 1 TUBE, WITH APPLICATOR | 04 Jan, 2016 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose antifungal
Product Elements:
Fungicure liquid gel clotrimazole hydroxypropyl cellulose (type m) isopropyl alcohol clotrimazole clotrimazole
Indications and Usage:
Uses for the cure of most ringworm (tinea corporis) athlete's foot (tinea pedis) for relief of itching scaling cracking burning redness soreness irritation discomforts which may accompany these conditions.
Warnings:
Warnings for external use only
When Using:
When using this product avoid contact with eyes.
Dosage and Administration:
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. apply 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 scalp or nails. avoid applying to severely cracked or irritated areas. for ringworm and athlete's foot, use daily for 4 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. 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. supervise children in the use of this product.
Stop Use:
Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks.
Information for Patients:
Other information fungicure may be applied to exposed nail-beds, cuticles, around nail edges and under nail tips where reachable with its applicator brush. this product is not intended to, nor will it, penetrate hard nail surfaces. 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 until satisfactory results are obtained. you may report serious side effects to the phone number provided under questions? below.
Spl Patient Package Insert:
Fungicure maximum strength liquid gel insert maximum strength fungicure liquid gel anti-fungal treatment kills 6 types of fungus on fingers and toes including around nails where reachable with its quickbrush applicator. what is fungus infection of the finger and toe areas? common 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 as ri
Read more...ng-like formations with clear centers; this is commonly called ringworm. athlete's foot fungus, when in the finger and toe areas, is 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 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 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 intact; they may be missing, cracked open, or lifted away, exposing the infected nail bed. in these instances fungicure anti-fungal liquid gel , 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 liquid gel works: maximum strength fungicure liquid gel contains clotrimazole, a widely recognized anti-fungal ingredient that has been proven to be effective against 6 types of fungus such as e. floccosum, t. mentagrophytes, m. canis, m. gypseum, t. tonsurans and t. rubrum. when applied as directed, fungicure liquid gel 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 liquid gel and discuss its use. for best results, once treatment is started with fungicure liquid gel , 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 and athlete's foot fungus. consult your doctor for advice if noticeable improvement is not evident by this time or if condition persists or worsens. active ingredient: clotrimazole 1% w/w uses: for the cure of most: ringworm (tinea corporis) and athlete's foot (tinea pedis). for relief of: itching, scaling, cracking, burning, redness, soreness, irritation and 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. 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. apply a thin layer of fungicure liquid gel over the affected area (including the exposed nail bed) twice daily (morning and night), or as directed by a doctor. this product is not effective on scalp or nails. avoid applying to severely cracked or irritated areas. 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. for athlete's foot and ringworm, use daily for 4 weeks. if condition persists longer, consult a doctor. 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. supervise children in the use of this product. other information: while not all finger and toe fungal infection are curable with otc topical medications, if you see improvement within 4 weeks of use, you may continue to use fungicure until satisfactory results are obtained. you may report serious side effects to the phone number provided under questions? below. inactive ingredients hydroxypropylcellulose and isopropyl alcohol. questions? 1-800-792-2582 fungicure.com the active ingredient in fungicure has been recognized to be safe and effective by an fda expert advisory panel when used as directed.
Package Label Principal Display Panel:
Fungicureliquidgelpdp
Further Questions:
Questions? 1-800-792-2582