Dermafungal
Antimicrobial Drug Products
Dermarite Industries, Llc
Human Otc Drug
NDC 61924-234Dermafungal also known as Antimicrobial Drug Products is a human otc drug labeled by 'Dermarite Industries, Llc'. National Drug Code (NDC) number for Dermafungal is 61924-234. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Dermafungal drug includes Miconazole Nitrate - .02 g/100g . The currest status of Dermafungal drug is Active.
Drug Information:
| Drug NDC: | 61924-234 |
| 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: | Dermafungal |
| 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: | Antimicrobial Drug Products |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Dermarite Industries, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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: | MICONAZOLE NITRATE - .02 g/100g
|
| 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: | 12 Dec, 2005 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 2025 |
| 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: | DermaRite industries, 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: | 0714196234049
|
| UPC stands for Universal Product Code. |
| UNII: | VW4H1CYW1K
|
| 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: | 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 |
|---|
| 61924-234-04 | 106 g in 1 TUBE (61924-234-04) | 12 Dec, 2005 | N/A | No |
| 61924-234-05 | 5 g in 1 PACKET (61924-234-05) | 12 Dec, 2005 | 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:
Dermafungal antimicrobial drug products medium-chain triglycerides polyoxyl 20 cetostearyl ether cetostearyl alcohol imidurea dimethicone edetate disodium glyceryl monostearate methylparaben peg-40 castor oil peg-100 stearate petrolatum propylene glycol propylparaben stearic acid water xanthan gum miconazole nitrate miconazole
Indications and Usage:
Uses: for the treatment and prevention of most: athlete's foot, jock itch, ringworm relieves itching, scaling,cracking, and discomfort associated with these conditions.
Warnings:
Warnings: for external use only. avoid contact with eyes . in case of contact, flush thoroughly with water. stop use and ask doctor if irritation occurs , condition worsens or does not improve in 2 weeks for jock itch, or within 4 weeks for athlete's foot and ringworm.
Dosage and Administration:
Directions cleanse affected area and dry thoroughly. apply a thin layer to affected area twice daily or as directed by physician. for jock itch use daily for two weeks. for athelete's foot use daily for four weeks.
Package Label Principal Display Panel:
Durmafungal principal display panel and drug facts dermafungal