Miconazole Nitrate Vaginal Cream, Usp

Miconazole Nitrate Vaginal Cream, Usp
SPL v2
SPL
SPL Set ID 85a52081-d9cc-44f0-a8d3-851a45c4eb10
Route
VAGINAL
Published
Effective Date 2025-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Benzoic Acid Butylated Hydroxyanisole Mineral Oil Apricot Kernel Oil Peg-6 Esters Pegoxol 7 Stearate Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2009-04-21

Description

Miconazole nitrate, USP 2% (100 mg in each applicator)

Purpose

Vaginal antifungal


Medication Information

Purpose

Vaginal antifungal

Description

Miconazole nitrate, USP 2% (100 mg in each applicator)

Uses
  • treats vaginal yeast infections

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

For vaginal use only

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:
    • o
      applicator:insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use.
    • o
      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
Do Not Use

if you have never had a vaginal yeast infection diagnosed by a doctor

Questions?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Active Ingredient

Miconazole nitrate, USP 2% (100 mg in each applicator)

Other Information
  • to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use

  • do not use if foil seal on tube opening is broken or missing
  • do not purchase if carton is open
  • store at room temperature 20°to 25°C (68°to 77°F)
  • before using any medication, read all label direction. Keep carton, it contains important information.
  • Relabeled By: Preferred Pharmaceuticals Inc.
Inactive Ingredients

benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

Principal Display Panel

Compare to the active ingredient in Monistat® 7 Vaginal Cream*

Miconazole 7

Miconazole Nitrate Vaginal Cream, USP 2%

(Miconazole Nitrate 100 mg per applicator)

2%

Vaginal Antifungal

Cures most vaginal yeast infections

Relieves associated external itching and irritation

7 day vaginal cream (1 tube) with 1 reusable applicator

NET WT OZ (g) Tube

*This product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat®.

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

www.majorpharmaceuticals.com

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.

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


Structured Label Content

Uses
  • treats vaginal yeast infections

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

Vaginal antifungal

Warnings

For vaginal use only

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:
    • o
      applicator:insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use.
    • o
      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
Do Not Use (Do not use)

if you have never had a vaginal yeast infection diagnosed by a doctor

Questions?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Active Ingredient (Active ingredient)

Miconazole nitrate, USP 2% (100 mg in each applicator)

Other Information (Other information)
  • to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use

  • do not use if foil seal on tube opening is broken or missing
  • do not purchase if carton is open
  • store at room temperature 20°to 25°C (68°to 77°F)
  • before using any medication, read all label direction. Keep carton, it contains important information.
  • Relabeled By: Preferred Pharmaceuticals Inc.
Inactive Ingredients (Inactive ingredients)

benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

Principal Display Panel (Principal display panel)

Compare to the active ingredient in Monistat® 7 Vaginal Cream*

Miconazole 7

Miconazole Nitrate Vaginal Cream, USP 2%

(Miconazole Nitrate 100 mg per applicator)

2%

Vaginal Antifungal

Cures most vaginal yeast infections

Relieves associated external itching and irritation

7 day vaginal cream (1 tube) with 1 reusable applicator

NET WT OZ (g) Tube

*This product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat®.

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

www.majorpharmaceuticals.com

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur


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