Dynarex Antifungal Powder
Miconazole
Dynarex Corporation
Human Otc Drug
NDC 67777-316Dynarex Antifungal Powder also known as Miconazole is a human otc drug labeled by 'Dynarex Corporation'. National Drug Code (NDC) number for Dynarex Antifungal Powder is 67777-316. This drug is available in dosage form of Powder. The names of the active, medicinal ingredients in Dynarex Antifungal Powder drug includes Miconazole Nitrate - 20 mg/g . The currest status of Dynarex Antifungal Powder drug is Active.
Drug Information:
| Drug NDC: | 67777-316 |
| 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: | Dynarex Antifungal Powder |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Dynarex Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Powder |
| 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 - 20 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: | 19 May, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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: | Dynarex Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 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: | 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 |
|---|
| 67777-316-02 | 24 BOTTLE, PLASTIC in 1 CASE (67777-316-02) / 85 g in 1 BOTTLE, PLASTIC (67777-316-01) | 19 May, 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 uses for external treatment of fungal infections such as athleteâs foot, jock itch, sweat rash, infected diaper rash and fungal infections affecting the skin folds e.g. armpits, groin, or under the breasts.
Product Elements:
Dynarex antifungal powder miconazole silicon dioxide talc miconazole nitrate miconazole
Indications and Usage:
Cautions please read this label carefully before use. ⢠dynarex antifungal powder is not suitable for the treatment of fungal infections of the scalp or nails, and you should talk to your doctor or pharmacist for alternative treatments for these conditions. in order to ensure successful treatment, it is important to use the powder regularly and to continue for at least 10 days after the disappearance of symptoms. this prevents the infection from reoccurring. ⢠remember that most fungal infections are very infectious and can easily be passed on to other family members. in order to prevent this happening, it is important to ensure that anyone who has an infection avoids sharing clothes, towels, or shoes with other family members. after applying the powder, wash and dry your hands thoroughly. if your skin condition does not improve after one weekâs use, please consult your doctor or pharmacist. ⢠if you forget to apply the powder, do not apply the missed dose, but appl
Read more...y the next dose as usual and continue as normal. do not apply two doses at the same time. interactions if you are taking oral anticoagulants (drugs used to thin the blood, such as warfarin), talk to your doctor or pharmacist before use. overdose excessive use can result in skin irritation, which usually disappears after discontinuation of therapy. in case of accidental ingestion of powder go to the hospital immediately.
Warnings:
Warnings for external use only. consult a doctor or pharmacist before using this product if you: â are sensitive to the listed ingredients or any similar medications â are pregnant, planning a pregnancy or breastfeeding when using this product: you may occasionally experience some side effects. these are rare and consist of local skin irritation or rashes, which occur if you are unusually sensitive to the ingredients listed.
Do Not Use:
Warnings for external use only. consult a doctor or pharmacist before using this product if you: â are sensitive to the listed ingredients or any similar medications â are pregnant, planning a pregnancy or breastfeeding when using this product: you may occasionally experience some side effects. these are rare and consist of local skin irritation or rashes, which occur if you are unusually sensitive to the ingredients listed.
Dosage and Administration:
Directions sprinkle onto the affected area twice daily. it can be safely applied to broken skin and may also be sprinkled onto clothes and footwear, which come into contact with the infected area.
Package Label Principal Display Panel:
Principal display panel dynarex antifungal powder 1236 antipowgp.jpg antifungal powder