Jock Itch
Miconazole Nitrate
Walgreen Company
Human Otc Drug
NDC 0363-1497Jock Itch also known as Miconazole Nitrate is a human otc drug labeled by 'Walgreen Company'. National Drug Code (NDC) number for Jock Itch is 0363-1497. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Jock Itch drug includes Miconazole Nitrate - 2 g/100g . The currest status of Jock Itch drug is Active.
Drug Information:
| Drug NDC: | 0363-1497 |
| 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: | Jock Itch |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Walgreen Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Spray |
| 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 - 2 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: | 23 Feb, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 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: | Walgreen Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 998428
|
| 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 |
|---|
| 0363-1497-90 | 130 g in 1 BOTTLE, SPRAY (0363-1497-90) | 23 Feb, 2018 | 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:
Jock itch miconazole nitrate miconazole nitrate miconazole alcohol aluminum starch octenylsuccinate isobutane isopropyl myristate propylene carbonate sorbitan monooleate stearalkonium hectorite talc off-white
Indications and Usage:
Uses proven clinically effective in the treatment of most jock itch (tinea cruris) for effective relief of itching, burning, scaling and discomfort, and chafing associated with jock itch
Warnings:
Warnings for external use only flammable: do not use while smoking or near heat or flame do not use on children under 2 years of age unless directed by a doctor when using this product avoid contact with the eyes use only as directed. intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal. contents under pressure. do not puncture or incinerate. do not store at temperature above 120°f (49°c). stop use and ask a doctor if irritation occurs there is no improvement within 2 weeks
Do Not Use:
Warnings for external use only flammable: do not use while smoking or near heat or flame do not use on children under 2 years of age unless directed by a doctor when using this product avoid contact with the eyes use only as directed. intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal. contents under pressure. do not puncture or incinerate. do not store at temperature above 120°f (49°c). stop use and ask a doctor if irritation occurs there is no improvement within 2 weeks
When Using:
When using this product avoid contact with the eyes use only as directed. intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal. contents under pressure. do not puncture or incinerate. do not store at temperature above 120°f (49°c).
Dosage and Administration:
Directions wash affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) supervise children in the use of this product use daily for 2 weeks if condition persists longer, ask a doctor this product is not effective on the scalp or nails in case of clogging, clean nozzle with a pin
Stop Use:
Stop use and ask a doctor if irritation occurs there is no improvement within 2 weeks
Package Label Principal Display Panel:
Package/label principal display panel compare to lotrimin® af powder spray active ingredient jock itch powder spray miconazole nitrate 2% / antifungal goes on dry clinically proven to cure most jock itch relieves itching, burning, scaling & chafing new wt 4.6 oz (130 g) jock itch powder spray label
Further Questions:
Questions or comments? 1-800-719-9260