Monistat 7 Combination Pack 7-day Pre-filled Applicators
Miconazole Nitrate
Insight Pharmaceuticals Llc
Human Otc Drug
NDC 63736-023Monistat 7 Combination Pack 7-day Pre-filled Applicators also known as Miconazole Nitrate is a human otc drug labeled by 'Insight Pharmaceuticals Llc'. National Drug Code (NDC) number for Monistat 7 Combination Pack 7-day Pre-filled Applicators is 63736-023. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Monistat 7 Combination Pack 7-day Pre-filled Applicators drug includes . The currest status of Monistat 7 Combination Pack 7-day Pre-filled Applicators drug is Active.
Drug Information:
| Drug NDC: | 63736-023 |
| 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: | Monistat 7 Combination Pack 7-day Pre-filled Applicators |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Monistat 7 Combination Pack |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | 7-Day Pre-Filled Applicators |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Insight Pharmaceuticals Llc |
| 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: | NDA |
| 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 Apr, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 Jun, 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: | NDA017450 |
| 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: | Insight Pharmaceuticals LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 998540
998541
1536610
1854816
|
| 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 |
|---|
| 63736-023-15 | 1 KIT in 1 PACKAGE, COMBINATION (63736-023-15) * 5 g in 1 TUBE, WITH APPLICATOR * 9 g in 1 TUBE | 23 Apr, 2020 | 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 vaginal antifungal vaginal antifungal
Product Elements:
Monistat 7 combination pack 7-day pre-filled applicators miconazole nitrate miconazole nitrate miconazole nitrate miconazole nitrate miconazole benzoic acid cetyl alcohol isopropyl myristate polysorbate 60 potassium hydroxide propylene glycol water stearyl alcohol miconazole nitrate miconazole nitrate miconazole nitrate miconazole benzoic acid cetyl alcohol isopropyl myristate polysorbate 60 potassium hydroxide propylene glycol water stearyl alcohol label
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 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 disease (stds). do not have vaginal intercourse mi
Read more...ld 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 after 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.
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 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 disease (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 after 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.
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 disease (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: ⪠applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. throw away applicator after use. ⪠external cream: squeeze a small amount of cream onto your fingertip. apply the cream onto the itchy, irritated skin outside the vagina (vulva). 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 after 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 - kit carton monistat ® 7 c o m b i n a t i o n p a c k miconazole nitrate vaginal cream (2%) and miconazole nitrate vaginal cream (2%) vaginal antifungal ⢠cures most vaginal yeast infections⢠relieves associated external itching and irritation vaginal cream with 7 disposable applicators plus external cream for itch relief net wt. 1.59 oz (45g) + 0.32 oz (9g) tube 7-day treatment combination pack cream 7 disposable applicators plus external cream for itch relief tamper-evident unit do not use if seal over type has been punctured. if you have any questions or comments, please call 1-877-monistat (1-877-666-4782) dist. by insight pharmaceuticals llc. tarrytown, ny 10591 a prestige consumer healthcare company ©2019 trade dress is owned by insight pharmaceuticals llc. all rights reserved, mnus1107 combination pack miconazole nitrate vaginal cream (2%) and miconazole nitrate cream (2%) vaginal antifungal vaginal cream with 7 disposable applicators net wt. 1.59 oz. (45g) plus external cream for itch relief + 0.32 oz. (9g) tube
Further Questions:
Questions? if you have any questions or comments, please call 1- 877-666- 4782