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Miconazole Nitrate

Miconazole Nitrate

Approved
Approval ID

6b34d0be-4bcd-4dff-b732-7fbd46765019

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 27, 2025

Manufacturers
FDA

Sun Pharmaceutical Industries, Inc.

DUNS: 146974886

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Miconazole Nitrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51672-2035
Application NumberANDA074444
Product Classification
M
Marketing Category
C73584
G
Generic Name
Miconazole Nitrate
Product Specifications
Route of AdministrationVAGINAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (5)

BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
MICONAZOLE NITRATEActive
Quantity: 20 mg in 1 g
Code: VW4H1CYW1K
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/22/2020

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

CURES most vaginal YEAST INFECTIONS
Relieves associated external itching and irritation

NDC 51672-2035-6

7 Day Treatment

7 Day Vaginal Cream

Miconazole Nitrate Vaginal Cream USP (2%)
(Miconazole Nitrate 100 mg per application)
Vaginal Antifungal

One 45 g (1.5 oz) tube of Miconazole Nitrate Vaginal Cream USP (2%)
& 1 Reusable Applicator

Consumer Information Leaflet Enclosed

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/22/2020

Uses

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 1/22/2020

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/22/2020

Active ingredient

Miconazole nitrate USP 2% (100 mg in each applicatorful)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/22/2020

Purpose

Vaginal antifungal

WARNINGS SECTION

LOINC: 34071-1Updated: 1/22/2020

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 aretaking 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 (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/22/2020

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: ***applicator:**insert 1 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 of age: ask a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 1/22/2020

Other information

  • do not purchase if carton is opened
  • do not use if seal over tube opening has been punctured or is not visible
  • store at 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/22/2020

Inactive ingredients

benzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and purified water.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 1/22/2020

Questions?

call1-866-923-4914

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Miconazole Nitrate - FDA Drug Approval Details