Topcare Antifungal Maximum Strength
Undecylenic Acid
Topco Associates Llc
Human Otc Drug
NDC 36800-754Topcare Antifungal Maximum Strength also known as Undecylenic Acid is a human otc drug labeled by 'Topco Associates Llc'. National Drug Code (NDC) number for Topcare Antifungal Maximum Strength is 36800-754. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Topcare Antifungal Maximum Strength drug includes Undecylenic Acid - 25 mg/30mL . The currest status of Topcare Antifungal Maximum Strength drug is Active.
Drug Information:
| Drug NDC: | 36800-754 |
| 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: | Topcare Antifungal Maximum Strength |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Topcare Antifungal |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Maximum Strength |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Undecylenic Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Topco Associates Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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: | UNDECYLENIC ACID - 25 mg/30mL
|
| 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: | 22 Apr, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 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: | TOPCO ASSOCIATES LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0036800339231
|
| UPC stands for Universal Product Code. |
| UNII: | K3D86KJ24N
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 36800-754-01 | 30 mL in 1 BOTTLE, WITH APPLICATOR (36800-754-01) | 22 Apr, 2019 | 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:
âpurpose anti-fungal
Product Elements:
Topcare antifungal maximum strength undecylenic acid undecylenic acid undecylenic acid isopropyl palmitate
Indications and Usage:
Uses ⪠proven effective in the treatment of most athleteâs foot (tinea pedis) and ringworm (tinea corporis) ⪠for effective relief of itching, burning and cracking.
Warnings:
Warnings for external use only do not use on children 2 years of age unless directed by a doctor. when using this product ⪠avoid contact with eyes stop use and consult a doctor if ⪠there is no improvement within 4 weeks ⪠irritation occurs keep this and all medication out of reach of children. if case of accidental ingestion, contact a physician, emergency medical care facility, or poison control center immediately for advice at 1-800-222-1222.
Do Not Use:
Warnings for external use only do not use on children 2 years of age unless directed by a doctor. when using this product ⪠avoid contact with eyes stop use and consult a doctor if ⪠there is no improvement within 4 weeks ⪠irritation occurs keep this and all medication out of reach of children. if case of accidental ingestion, contact a physician, emergency medical care facility, or poison control center immediately for advice at 1-800-222-1222.
When Using:
When using this product ⪠avoid contact with eyes
Dosage and Administration:
âdirections read all warnings and directions. use only as directed. ⪠clean the affected area with soap and warm water and dry thoroughly. ⪠apply a thin layer of anti-fungal liquid solution over affected area twice daily (morning and night) or as directed by a doctor. ⪠the brush applicator allows for easy application under nails and surrounding cuticle area. ⪠wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. ⪠for athlete's foot: pay special attention to spaces between toes. ⪠for athlete's foot and ringworm, use daily for 4 weeks. if conditions persists longer, consult a doctor . ⪠this product is not effective on the scalp or nails. ⪠supervise children in the use of this product.
Stop Use:
Stop use and consult a doctor if ⪠there is no improvement within 4 weeks ⪠irritation occurs
Package Label Principal Display Panel:
Principal display panel ndc 36800-754-01 compare to fungicure® active ingredient* maximum strength anti-fungal liquid ⢠topical formula for toe and foot ⢠stops most athleteâs foot fungus and ringworm ⢠helps relieves related discomforts 1 fl oz (30ml) quality guranteed this top care® product is laboratory tested to guarantee its highest quality. your total satisfaction is guaranteed. side panel how to eliminate fungus? toe fungus can affect the areas around the cuticles and the skin around the tip of the nails. anti-fungal work on contact but do not penetrate the nail, so make sure tom keep nails clipped and clean away flaky skin and nail keratin when treating affected areas. anti-fungal liquid solution gets into hard to reach places, right where itâs needed, to treat fungus and stop it from spreading. when will you see results? ⢠anti-fungal liquid begins working immediately to eliminate toe and athleteâs foot fungus. ⢠you should begin to see results in 4 weeks. ⢠you may need to continue treating to allow for regrowth of healthy new tissue. *this product is not manufactured or distributed by alva-amco pharmacal companies, the distributor of fungicure ® . distributed by topco associates llc elkgrove village, il 60007 © topco rse515 questions? 1-888-423-0139 topcare@topco.com www.topcarebrand.com anti- fungal liquid topcare maximum strength 30 ml
Further Questions:
Questions? call 1-888-423-0139