Miconazole 3 Kit
FDA Label NDC 69842-950

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Miconazole 3 (NDC 69842-950). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Miconazole nitrate (200 mg in each vaginal insert)

Miconazole nitrate 2% (external cream)

Purpose

Vaginal antifungal

Vaginal antifungal

Uses

• treats vaginal yeast infections

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

Warnings

For vaginal use only

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

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.

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. Throw away applicator 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

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

Principal Display Panel

Compare to the active ingredients of Monistat® 3
3-Day Treatment; 3-Step System
Yeast Infection Relief
Miconazole 3
MICONAZOLE NITRATE VAGINAL INSERTS (200 mg)
MICONAZOLE NITRATE CREAM (2%)
Vaginal Antifungal
Combination Pack

  • Cures most vaginal yeast infections
  • Relieves associated external itching & irritation
  • 3 VAGINAL SOFTGEL INSERTS, 3 APPLICATORS, 1 EXTERNAL CREAM, 4 FEMININE WIPES
    NET WT 3 VAGINAL SOFTGEL INSERTS + 0.32 OZ (9 g) TUBE

    Principal Display Panelcompare To The Active Ingredients Of Monistat® 33-day Treatment; 3-step Systemyeast Infection Relief Miconazole 3miconazole Nitrate Vaginal Suppositories (200 mg)miconazole Nitrate Cream (2%)vaginal Antifungalcombination Pack•	Cures Most Vaginal Yeast Infections•	Relieves Associated External Itching & Irritation3 Vaginal Softgel Inserts, 3 Applicators, 1 External Cream, 4 Feminine Wipesnet Wt 3 Vaginal Softgel Inserts + 0.32 Oz (9g) Tube (Miconazole 3 Complete Pack Kit 01)

    Principal Display Panelcompare To The Active Ingredients Of Monistat® 33-day Treatment; 3-step Systemyeast Infection Relief Miconazole 3miconazole Nitrate Vaginal Suppositories (200 mg)miconazole Nitrate Cream (2%)vaginal Antifungalcombination Pack• Cures Most Vaginal Yeast Infections• Relieves Associated External Itching & Irritation3 Vaginal Softgel Inserts, 3 Applicators, 1 External Cream, 4 Feminine Wipesnet Wt 3 Vaginal Softgel Inserts + 0.32 Oz (9g) Tube (Miconazole 3 Complete Pack Kit 01)

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