Miconazole Nitrate
Rugby Laboratories, Inc.
Human Otc Drug
NDC 0536-1134Miconazole Nitrate is a human otc drug labeled by 'Rugby Laboratories, Inc.'. National Drug Code (NDC) number for Miconazole Nitrate is 0536-1134. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Miconazole Nitrate drug includes Miconazole Nitrate - 20 mg/g . The currest status of Miconazole Nitrate drug is Active.
Drug Information:
| Drug NDC: | 0536-1134 |
| 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: | Miconazole Nitrate |
| 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: | Rugby Laboratories, Inc. |
| 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 - 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: | 01 Oct, 1991 |
| 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: | Rugby Laboratories, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 998483
|
| 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 |
|---|
| 0536-1134-28 | 1 TUBE in 1 CARTON (0536-1134-28) / 30 g in 1 TUBE | 19 May, 2017 | 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:
Miconazole nitrate miconazole nitrate miconazole nitrate miconazole apricot kernel oil benzoic acid butylated hydroxytoluene glycol stearate mineral oil polyethylene glycol 300 water stearyl alcohol
Indications and Usage:
Uses effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) for effective relief of itching, scaling, burning and discomfort that can accompany these conditions
Warnings:
Warnings for external use only do not use on children less than 2 years of age unless directed by a doctor when using this product avoid contact with eyes stop use and ask a doctor if irritation occurs condition persists there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away (1-800-222-1222).
Do Not Use:
Warnings for external use only do not use on children less than 2 years of age unless directed by a doctor when using this product avoid contact with eyes stop use and ask a doctor if irritation occurs condition persists there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away (1-800-222-1222).
When Using:
When using this product avoid contact with 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) 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 for jock itch: use daily for 2 weeks not effective on the scalp or nails
Stop Use:
Stop use and ask a doctor if irritation occurs condition persists there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.
Package Label Principal Display Panel:
Principal display panel - 30 g tube carton rugby antifungal cream cures most athlete's foot miconazole nitrate cream usp, 2% antifungal cream net wt 1 oz (30 g) principal display panel - 30 g tube carton
Further Questions:
Questions? call 1-866-923-4914