NDC 57501-006 Monistat 3 Combination Pack

Miconazole Nitrate

NDC Product Code 57501-006

NDC 57501-006-01

Package Description: 1 KIT in 1 PACKAGE, COMBINATION * 5 g in 1 APPLICATOR * 9 g in 1 TUBE

NDC Product Information

Monistat 3 Combination Pack with NDC 57501-006 is a a human over the counter drug product labeled by Apex International Mfg., Inc.. The generic name of Monistat 3 Combination Pack is miconazole nitrate. The product's dosage form is kit and is administered via form.

Labeler Name: Apex International Mfg., Inc.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Apex International Mfg., Inc.
Labeler Code: 57501
FDA Application Number: NDA020670 What is the FDA Application Number?
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.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 06-11-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Monistat 3 Combination Pack Product Label Images

Monistat 3 Combination Pack Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Purpose

Miconazole nitrate 4% (200 mg in each applicator)
     
Vaginal antifungalMiconazole nitrate 2% (external cream)
     
Vaginal antifungal

Uses

  • Treats vaginal yeast infectionsrelieves external itching and irritation due to a vaginal yeast infection

Warnings

For vaginal use only

Otc - Do Not Use

  • Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.Ask a doctor before use if you havevaginal itching and discomfort for the first timelower 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

Otc - Ask Doctor/Pharmacist

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 intercoursemild increase in vaginal burning, itching or irritation may occurif 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 dayssymptoms last more than 7 daysyou 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.

Directions

  • Before using this product read the enclosed consumer information leaflet for complete directions and informationadults and children 12 years of age and over:applicators: insert 1 suppository into the vagina at bedtime for 3 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. Use 2 times daily for up to 7 days, as needed. children under 12 years of age: ask a doctor

Other Information

  • Do not use if printed suppository wrapper is torn, open or incompletely sealeddo not use if seal over tube opening has been punctureddo not purchase if carton is openstore at 20°-25°C (68°-77°F)

Inactive Ingredients

Benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol

Questions?

If you have any questions or comments, please call 1-877-666-4782

* Please review the disclaimer below.