Miconazole 3 Combination Pack

Miconazole 3 Combination Pack
SPL v15
SPL
SPL Set ID d01f7ef9-4f04-4874-a625-0335f6392b73
Route
VAGINAL
Published
Effective Date 2025-09-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (200 mg)
Inactive Ingredients
Hydrogenated Palm Kernel Oil Benzoic Acid Butylated Hydroxyanisole Mineral Oil Apricot Kernel Oil Peg-6 Esters Pegoxol 7 Stearate Water

Identifiers & Packaging

Marketing Status
ANDA Completed Since 2003-09-11 Until 2026-12-31

Description

Miconazole nitrate, USP 200 mg (in each suppository) Miconazole nitrate, USP 2% (external cream)

Purpose

Vaginal antifungal   


Medication Information

Purpose

Vaginal antifungal   

Description

Miconazole nitrate, USP 200 mg (in each suppository) Miconazole nitrate, USP 2% (external cream)

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:
    • suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Throw applicator away after use.
    • external cream: Use cap to puncture seal. 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
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

Package Label
PREMIER VALUE Miconazole 3 Combination pack Vaginal Antifungal
Other Information
  • do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped)
  • do not use if seal over tube opening has been punctured or is not visible
  • do not purchase if carton is open
  • store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F).
Active Ingredients

Miconazole nitrate, USP 200 mg (in each suppository)

Miconazole nitrate, USP 2% (external cream)

Inactive Ingredients
  • suppository: hydrogenated vegetable oil
  • external cream: benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water
Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN MONISTAT® 3*

Miconazole 3

Combination Pack

Vaginal Antifungal

Miconazole Nitrate Vaginal Suppositories , USP 200 mg

and Miconazole Nitrate Vaginal Cream USP 2%

Cures most vaginal yeast infections and relieves associated external itching and irritation

3 Day Treatment

3 Miconazole Nitrate Vaginal Suppositories, USP 200 mg plus

1 tube Miconazole Nitrate Vaginal Cream, USP 2%

*this product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat®3.

Net Wt OZ (g)

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue, Wayne, PA 19087

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.
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 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.

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 and 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:
    • suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Throw applicator away after use.
    • external cream: Use cap to puncture seal. 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
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

Package Label (Package label)
PREMIER VALUE Miconazole 3 Combination pack Vaginal Antifungal
Other Information (Other information)
  • do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped)
  • do not use if seal over tube opening has been punctured or is not visible
  • do not purchase if carton is open
  • store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F).
Active Ingredients (Active ingredients)

Miconazole nitrate, USP 200 mg (in each suppository)

Miconazole nitrate, USP 2% (external cream)

Inactive Ingredients (Inactive ingredients)
  • suppository: hydrogenated vegetable oil
  • external cream: 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® 3*

Miconazole 3

Combination Pack

Vaginal Antifungal

Miconazole Nitrate Vaginal Suppositories , USP 200 mg

and Miconazole Nitrate Vaginal Cream USP 2%

Cures most vaginal yeast infections and relieves associated external itching and irritation

3 Day Treatment

3 Miconazole Nitrate Vaginal Suppositories, USP 200 mg plus

1 tube Miconazole Nitrate Vaginal Cream, USP 2%

*this product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat®3.

Net Wt OZ (g)

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue, Wayne, PA 19087

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.
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 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 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 and bruising may occur.


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