Miconatate
Miconazole Nitrate And Tolnaftate
Puretek Corporation
Human Otc Drug
NDC 59088-778Miconatate also known as Miconazole Nitrate And Tolnaftate is a human otc drug labeled by 'Puretek Corporation'. National Drug Code (NDC) number for Miconatate is 59088-778. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Miconatate drug includes . The currest status of Miconatate drug is Active.
Drug Information:
| Drug NDC: | 59088-778 |
| 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: | Miconatate |
| 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: | Miconazole Nitrate And Tolnaftate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Puretek Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| 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: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| 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: | 02 Sep, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 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, 2024 |
| 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: | PureTek Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 313423
998461
|
| 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. |
| UNII: | |
| 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 |
|---|
| 59088-778-00 | 1 KIT in 1 CARTON (59088-778-00) * 30 mL in 1 BOTTLE, WITH APPLICATOR (59088-443-03) * 85 g in 1 BOTTLE (59088-442-07) | 02 Sep, 2021 | 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
Purpose antifungal
Product Elements:
Miconatate miconazole nitrate and tolnaftate mycozyl al tolnaftate tea tree oil glycerin apple cider vinegar laureth-4 benzyl alcohol .alpha.-tocopherol acetate, dl- dimethyl sulfoxide eucalyptus oil lavender oil polyethylene glycol 400 argan oil tolnaftate tolnaftate mycozyl ap miconazole nitrate levomenol carthamus tinctorius (safflower) oleosomes sodium benzoate ginger cananga odorata flower xylitol silicon dioxide aloe vera leaf nylon-12 starch, corn kukui nut oil miconazole nitrate miconazole hyaluronate sodium
Indications and Usage:
Uses for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions.
Uses for the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis). relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions. for the prevention of most athleteâs foot with daily use. eliminates fungus on fingers, toes, and around the nails. eliminates and helps stop the spread of fungal infections on cuticles around nail edges and under the nail tips where reachable with applicator brush.
Warnings:
Warnings for external use only.
Warnings for external use only
Do Not Use:
Warnings for external use only.
Warnings for external use only
When Using:
When using this product do not get into eyes
When using this product do not get into eyes
Dosage and Administration:
Directions clean the affected area and dry thoroughly apply a thin layer of the product over affected area twice daily (morning and night) paying special attention to the edges of the nail, cuticles, and skin around the nails or as directed by a doctor supervise children in the use of this product for athlete's foot, pay special attention to spaces between the 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. use under the direction of a medical practitioner
Stop Use:
Stop use and ask a doctor if for athlete's foot and ringworm - irritation occurs or there is no improvement within 4 weeks for jock itch - irritation occurs or there is no improvement within 2 weeks
Stop use and ask a doctor for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks for prevention of athleteâs foot - if irritation occurs, discontinue use and consult a doctor
How Supplied:
How supplied mycozyl al⢠antifungal liquid is supplied in a 1 fl oz / 30 ml glass bottle with a screw cap fitted with a brush applicator (ndc 59088-443-03)
Package Label Principal Display Panel:
Miconatate⢠packaged in the usa by: puretek corporation panorama city, ca 91402 for questions or information call toll-free: 877-921-7873 label