NDC 70518-2338 Miconazole Nitrate

Miconazole Nitrate

NDC Product Code 70518-2338

NDC 70518-2338-0

Package Description: 1 TUBE, WITH APPLICATOR in 1 CARTON > 45 g in 1 TUBE, WITH APPLICATOR

NDC Product Information

Miconazole Nitrate with NDC 70518-2338 is a a human over the counter drug product labeled by Remedyrepack Inc.. The generic name of Miconazole Nitrate is miconazole nitrate. The product's dosage form is cream and is administered via vaginal form.

Labeler Name: Remedyrepack Inc.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Miconazole Nitrate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MICONAZOLE NITRATE 20 mg/g

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.

  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • WATER (UNII: 059QF0KO0R)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Vaginal - Administration into the vagina.

Product Labeler Information

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

Labeler Name: Remedyrepack Inc.
Labeler Code: 70518
FDA Application Number: ANDA074444 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: ANDA - A product marketed under an approved Abbreviated 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: 10-02-2019 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: 12-31-2020 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.

Miconazole Nitrate Product Label Images

Miconazole Nitrate 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

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Drug Facts

Distributed by:


Taro Pharmaceuticals


U.S.A., Inc.


Hawthorne, NY 10532

Active Ingredient

Miconazole Nitrate USP 2% (100 mg per applicator)

Purpose

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

Otc - Ask 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

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

Otc - 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 intercoursemild increase in vaginal burning, itching or irritation may occurif you do not get complete relief ask a doctor before using another product.

Otc - Stop Use

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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:
  • Applicator: insert one applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use.
  • Use the same tube of cream if you have itching and irritation on the skin outside the vagina.
  • Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina (vulva).
  • Use 2 times daily for up to 7 days as needed.
  • Children under 12 years: ask a doctor

Other Information

  • Do not purchase if carton is openeddo not use if seal over tube opening has been punctured or is not visibleTo open: unscrew cap, use pointed end on cap to puncture seal
  • To close: screw cap back onto the tube
  • Store at 20°-25°C (68°-77°F)see carton or tube crimp for lot number and expiration date

Inactive Ingredients

Apricot Kernel Oil/PEG-6, Butylated Hydroxytoluene, Mineral Oil, PEG-6-32 Stearate/Glycol Stearate, Purified Water and Benzoic Acid (0.20%) as a preservative

Questions?

Call


1-866-923-4914

* Please review the disclaimer below.