Miconazole 1 Combination Pack

Miconazole 1 Combination Pack
SPL v4
SPL
SPL Set ID 1fe7b02a-f60b-4572-b4e8-35bda290b176
Route
VAGINAL
Published
Effective Date 2021-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (1200 mg)
Inactive Ingredients
Gelatin Glycerin Mineral Oil Titanium Dioxide Petrolatum Benzoic Acid Cetyl Alcohol Isopropyl Myristate Polysorbate 60 Potassium Hydroxide Propylene Glycol Water Stearyl Alcohol

Identifiers & Packaging

Marketing Status
NDA Active Since 2021-11-30

Description

Drug Facts

Purpose

Vaginal antifungal Vaginal antifungal


Medication Information

Purpose

Vaginal antifungal

Vaginal antifungal

Description

Drug Facts

Uses
  • treats vaginal yeast infections

  • relieves external itching and irritation due to a vaginal yeast infection
Section 42229-5

Drug Facts

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:
    • vaginal insert: with the applicator, place the vaginal insert into the vagina. Throw applicator away after use.

    • external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the 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
Questions?

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

Do Not Use If

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

Other Information
  • do not use if printed sealed pouch is torn, open or incompletely sealed

  • do not use if seal over tube opening has been punctured

  • do not purchase if carton is open

  • store at 20°-25°C (68°-77°F)

  • this is a 1-dose treatment. Most women do not get complete relief of their symptoms in just 1 day. Most women get some improvement in 1 day and complete relief by 7 days.
Active Ingredients

Miconazole nitrate 1200 mg (in vaginal insert)

Miconazole nitrate 2% (external cream)

Inactive Ingredients

vaginal insert: gelatin, glycerin, lecithin, mineral oil, titanium dioxide, white petrolatum

external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol

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 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
Principal Display Panel Kit Carton

Miconazole

Miconazole Nitrate Vaginal Insert (1200 mg)

Miconazole Nitrate Cream (2%)



VAGINAL ANTIFUNGAL | 1-DAY TREATMENT

Net Wt. 0.32oz (9g) tube & 1 OVULE Insert

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
Section 42229-5 (42229-5)

Drug Facts

Purpose

Vaginal antifungal

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:
    • vaginal insert: with the applicator, place the vaginal insert into the vagina. Throw applicator away after use.

    • external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the 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
Questions?

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

Do Not Use If (Do not use if)

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

Other Information (Other information)
  • do not use if printed sealed pouch is torn, open or incompletely sealed

  • do not use if seal over tube opening has been punctured

  • do not purchase if carton is open

  • store at 20°-25°C (68°-77°F)

  • this is a 1-dose treatment. Most women do not get complete relief of their symptoms in just 1 day. Most women get some improvement in 1 day and complete relief by 7 days.
Active Ingredients (Active ingredients)

Miconazole nitrate 1200 mg (in vaginal insert)

Miconazole nitrate 2% (external cream)

Inactive Ingredients (Inactive ingredients)

vaginal insert: gelatin, glycerin, lecithin, mineral oil, titanium dioxide, white petrolatum

external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol

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 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
Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

Miconazole

Miconazole Nitrate Vaginal Insert (1200 mg)

Miconazole Nitrate Cream (2%)



VAGINAL ANTIFUNGAL | 1-DAY TREATMENT

Net Wt. 0.32oz (9g) tube & 1 OVULE Insert

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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