Miconazole 3

Miconazole Nitrate


Walgreen Company
Human Otc Drug
NDC 0363-0081
Miconazole 3 also known as Miconazole Nitrate is a human otc drug labeled by 'Walgreen Company'. National Drug Code (NDC) number for Miconazole 3 is 0363-0081. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Miconazole 3 drug includes . The currest status of Miconazole 3 drug is Active.

Drug Information:

Drug NDC: 0363-0081
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 3
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: 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: ANDA
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 Jul, 2005
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: ANDA075329
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:992765
992766
998483
998540
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
0363-0081-001 KIT in 1 CARTON (0363-0081-00) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE01 Jul, 2005N/ANo
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 vaginal antifungal

Product Elements:

Miconazole 3 miconazole nitrate miconazole nitrate miconazole nitrate miconazole nitrate miconazole cottonseed oil to off white, opaque miconazole nitrate miconazole nitrate miconazole nitrate miconazole benzoic acid butylated hydroxyanisole glyceryl monostearate mineral oil water peg-5 oleate pegoxol 7 stearate

Indications and Usage:

Uses • treats vaginal yeast infections • relieves external itching and irritation due to a vaginal yeast infection

Warnings:

Warnings for vaginal use only do not use if you have never had a vaginal yeast infection diagnosed by a doctor. ask a doctor before use if you have • vaginal itching and discomfort for the first time • lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. you may have a more serious condition. • vaginal yeast infections often (such as once a month or 3 in 6 months). you could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. • been exposed to the human immunodeficiency virus (hiv) that causes aids ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur. when using this product • do not use tampons, douches, spermicides or other vaginal products. condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (stds). • do not have
vaginal intercourse • mild increase in vaginal burning, itching or irritation may occur • if you do not get complete relief ask a doctor before using another product stop use and ask a doctor if: • symptoms do not get better in 3 days • symptoms last more than 7 days • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge if pregnant or breast-feeding, ask a health professional before use. 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 vaginal use only do not use if you have never had a vaginal yeast infection diagnosed by a doctor. ask a doctor before use if you have • vaginal itching and discomfort for the first time • lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. you may have a more serious condition. • vaginal yeast infections often (such as once a month or 3 in 6 months). you could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. • been exposed to the human immunodeficiency virus (hiv) that causes aids ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur. when using this product • do not use tampons, douches, spermicides or other vaginal products. condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (stds). • do not have vaginal intercourse • mild increase in vaginal burning, itching or irritation may occur • if you do not get complete relief ask a doctor before using another product stop use and ask a doctor if: • symptoms do not get better in 3 days • symptoms last more than 7 days • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge if pregnant or breast-feeding, ask a health professional before use. 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 • do not use tampons, douches, spermicides or other vaginal products. condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (stds). • do not have vaginal intercourse • mild increase in vaginal burning, itching or irritation may occur • if you do not get complete relief ask a doctor before using another product

Dosage and Administration:

Directions • before using this product read the enclosed consumer information leaflet for complete directions and information • adults and children 12 years of age and over: • suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. throw applicator away after use. • external cream: squeeze a small amount of cream onto your fingertip. apply the cream onto the itchy, irritated skin outside the vagina. use 2 times daily for up to 7 days, as needed. • children under 12 years of age: ask a doctor

Stop Use:

Stop use and ask a doctor if: • symptoms do not get better in 3 days • symptoms last more than 7 days • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

Package Label Principal Display Panel:

Principal display panel walgreens walgreens pharmacist recommended suppository combination pack 3-day treatment 3 vaginal suppositories & disposable applicators cream for external relief walgreens walgreens pharmacist recommended compare to the active ingredients in monistat ® 3 miconazole 3 miconazole nitrate vaginal suppositories (200 mg) & miconazole nitrate vaginal cream (2%) vaginal antifungal | combination pack | 3-day treatment • cures most vaginal yeast infections & relieves associated external itching & irritation 3 vaginal suppositories with disposable applicators plus external cream net wt 0.32 oz (9 g) tube & 3 suppositories 2.5 g each miconazole 3 image 1 miconazole 3 image 2

Further Questions:

Questions or comments? 1-800-719-9260


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.