Kerasal Athletes Foot Rapid Symptom Relief Powder, For Solution
NDC 16864-140
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Kerasal Athletes Foot Rapid Symptom Relief (aluminum sulfate tetradecahydrate and calcium acetate monohydrate) is a OTC MONOGRAPH DRUG-approved product labeled by Advantice Health, Llc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white powder, for solution for topical administration. This product entry covers the primary NDC 16864-140 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
16864-140
Proprietary Name:
Kerasal Athletes Foot Rapid Symptom Relief Medicated Soak
Non-Proprietary Name: [1]
Aluminum Sulfate Tetradecahydrate And Calcium Acetate Monohydrate
Substance Name: [2]
Aluminum Sulfate Tetradecahydrate; Calcium Acetate Monohydrate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Powder, For Solution
- An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route(s): [4]
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
16864
Product Label ID:
FDA Application Number: [6]
M016
Marketing Category: [8]
OTC MONOGRAPH DRUG
Marketing Timeline
Start Marketing Date: [9]
06-26-2012
End Marketing Date: [10]
09-30-2028
Exclude Flag: [12]
N
Product Characteristics
Color(s):
WHITE (C48325)
Code Structure Chart
Product Details
What is NDC 16864-140?
The NDC code 16864-140 is assigned by the FDA to the product Kerasal Athletes Foot Rapid Symptom Relief Medicated Soak. It is commonly known by its generic name, aluminum sulfate tetradecahydrate and calcium acetate monohydrate. This pharmaceutical product is labeled by Advantice Health, Llc. and is currently categorized as listed product. The medication is a powder, for solution administered via topical route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 16864-140-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
Dissolve 1 to 3 packets in a pint (16 oz) of cool or warm waterstir until fully dissolved; do not strain or filter. The resulting mixture contains 0.16% (1 packet), 0.32% (2 packets), or 0.48% (3 packets) aluminum acetate and is ready for use.
What are Active Ingredients of this product?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- ALUMINUM SULFATE TETRADECAHYDRATE (UNII: E3UT66504P)
- ALUMINUM CATION (UNII: 3XHB1D032B) (Active Moiety)
- CALCIUM ACETATE MONOHYDRATE (UNII: 7ZA48GIM5H)
- ACETATE ION (UNII: 569DQM74SC) (Active Moiety)
Which are the Inactive Ingredients associated UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- ICODEXTRIN (UNII: 2NX48Z0A9G)
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 1250234 - aluminum sulfate 1347 MG / calcium acetate 952 MG in 160 ML Topical Solution
- RxCUI: 1250234 - aluminum sulfate 8.42 MG/ML / calcium acetate 5.95 MG/ML Topical Solution
- RxCUI: 1250234 - (3 Packets (aluminum sulfate 1347 MG Powder / calcium acetate 952 MG Powder)) per 16 OZ Topical Solution
- RxCUI: 1250234 - aluminum sulfate 1347 MG / calcium acetate 952 MG per 160 ML Topical Solution
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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? 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.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? 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.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
