Miconazole 1 Combination Pack Kit
FDA Label NDC 51316-005

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, Inc for the product Miconazole 1 Combination Pack (NDC 51316-005). 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 purpose, uses, warnings, do not use, 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.

Purpose

Miconazole nitrate 1200 mg (in vaginal insert)             Vaginal antifungal

Miconazole nitrate 2% (external cream)       Vaginal antifungal

Uses

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

Warnings

For vaginal use only

Do Not Use

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

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 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

Other Information

  • do not use if printed sealed pouch or sealed vaginal insert blister 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.

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

Questions?

call toll-free 877-666-4782

Principal Display Panel

Miconazole 1
Miconazole Nitrate Vaginal Insert (1200 mg)

Miconazole Nitrate Cream (2%)

VAGINAL ANTIFUNGAL | Yeast infection relief

  • Cures most vaginal yeast infections
  • Relieves associated external itching & irritation
  • Net Wt. 0.32oz (9g) tube

    1 Vaginal Softgel Insert + Applicator

    Principal Display Panel Miconazole 1miconazole Nitrate Vaginal Insert (1200 mg) Miconazole Nitrate Cream (2%)vaginal Antifungal | Yeast Infection Relief•	Cures Most Vaginal Yeast Infections•	Relieves Associated External Itching & Irritationnet Wt. 0.32oz (9g) Tube1 Vaginal Softgel Insert + Applicator (Miconazole 1 Combination Pack 01)

    Principal Display Panel Miconazole 1miconazole Nitrate Vaginal Insert (1200 mg) Miconazole Nitrate Cream (2%)vaginal Antifungal | Yeast Infection Relief• Cures Most Vaginal Yeast Infections• Relieves Associated External Itching & Irritationnet Wt. 0.32oz (9g) Tube1 Vaginal Softgel Insert + Applicator (Miconazole 1 Combination Pack 01)

    Principal Display Panel Miconazole 1miconazole Nitrate Vaginal Insert (1200 mg) Miconazole Nitrate Cream (2%)vaginal Antifungal | Yeast Infection Relief•	Cures Most Vaginal Yeast Infections•	Relieves Associated External Itching & Irritationnet Wt. 0.32oz (9g) Tube1 Vaginal Softgel Insert + Applicator (Miconazole 1 Combination Pack 02)

    Principal Display Panel Miconazole 1miconazole Nitrate Vaginal Insert (1200 mg) Miconazole Nitrate Cream (2%)vaginal Antifungal | Yeast Infection Relief• Cures Most Vaginal Yeast Infections• Relieves Associated External Itching & Irritationnet Wt. 0.32oz (9g) Tube1 Vaginal Softgel Insert + Applicator (Miconazole 1 Combination Pack 02)

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