miconazole 3 combination pack

miconazole 3 combination pack
SPL v2
SPL
SPL Set ID 32b373be-9c8e-49b0-a796-8d87f6a20cef
Route
vaginal
Published
Effective Date 2026-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
miconazole (200 mg)
Inactive Ingredients
glycerin titanium dioxide gelatin benzoic acid cetyl alcohol isopropyl myristate polysorbate 60 potassium hydroxide propylene glycol water stearyl alcohol

Identifiers & Packaging

Marketing Status
nda active Since 2016-04-18

Purpose

Vaginal antifungal Vaginal antifungal

Description

Drug Facts


Medication Information

Warnings

For vaginal use only

Uses
  • treats vaginal yeast infections

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

Vaginal antifungal

Vaginal antifungal

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 a disposable applicator, place the insert into the vagina at bedtime for three nights in a row. 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. Use 2 times daily for up to 7 days, as needed.


  • children under 12 years of age: ask a doctor.
Other Information
  • do not use if printed sealed pouches containing vaginal inserts are 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)
Inactive Ingredients

vaginal insert: gelatin, glycerin, hydrogenated vegetable oil base, titanium dioxide

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

Description

Drug Facts

Principal Display Panel

- Kit Carton

Miconazole 3

Miconazole Nitrate Vaginal Inserts (200 mg) &

Miconazole Nitrate Cream (2%) 

Vaginal Antifungal | 3-Day Treatment

3 Ready-to-Use Vaginal Inserts

Cream for External Relief

Net Wt. 0.32 oz (9 g) TUBE

3 Vaginal Inserts Net Wt. 2.5 g each

Questions?

call toll-free 1-8 55-590-5695

Section 42229-5

Drug Facts

Do Not Use

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

Active Ingredients

Miconazole nitrate (200 mg in each vaginal insert)

Miconazole nitrate 2% (external cream)

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, f ever, 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 (1-800-222-1222).

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

Warnings

For vaginal use only

Uses
  • treats vaginal yeast infections

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

Vaginal antifungal

Vaginal antifungal

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 a disposable applicator, place the insert into the vagina at bedtime for three nights in a row. 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. Use 2 times daily for up to 7 days, as needed.


  • children under 12 years of age: ask a doctor.
Other Information
  • do not use if printed sealed pouches containing vaginal inserts are 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)
Inactive Ingredients (Inactive ingredients)

vaginal insert: gelatin, glycerin, hydrogenated vegetable oil base, titanium dioxide

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

- Kit Carton

Miconazole 3

Miconazole Nitrate Vaginal Inserts (200 mg) &

Miconazole Nitrate Cream (2%) 

Vaginal Antifungal | 3-Day Treatment

3 Ready-to-Use Vaginal Inserts

Cream for External Relief

Net Wt. 0.32 oz (9 g) TUBE

3 Vaginal Inserts Net Wt. 2.5 g each

Questions?

call toll-free 1-8 55-590-5695

Section 42229-5 (42229-5)

Drug Facts

Do Not Use (Do not use)

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

Active Ingredients (Active ingredients)

Miconazole nitrate (200 mg in each vaginal insert)

Miconazole nitrate 2% (external cream)

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, f ever, 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 (1-800-222-1222).

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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