Miconazole Nitrate
FDA Label NDC 76413-318

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Central Texas Community Health Centers for the product Miconazole Nitrate (NDC 76413-318). 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 ingredient, purpose, uses, warnings, if pregnant or breast feeding,, keep out of reach of children, dosage & administration, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ If Pregnant Or Breast Feeding,

→ Keep Out Of Reach Of Children

→ Dosage & Administration

→ Other Information

→ Inactive Ingredient

→ Principal Display Panel - 45 G Tube Label

Active Ingredient

Miconazole nitrate 2% (100 mg in each applicator)
Miconazole nitrate 2% (as external cream)

Purpose

Vaginal antifungal

Uses

• treats repeat vaginal yeast infections
• relieves external itching and irritation due to a repeat 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 medication warfarin, because bleeding or bruising may occur.

When using this product
• do not use tampons, douches, spermicides, or other vaginal products
• do not have vaginal intercourse
• condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs)

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.

Dosage & Administration

• before using this product read the enclosed consumer information leaflet for complete instructions
• adults and children 12 years of age and over:
         • applicator: insert one applicatorful into the vagina at bedtime for 7 nights in a row
         • external cream: squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated
             skin outside the vagina. Use daily for up to 7 days as needed
• children under 12 years of age: ask a doctor

Other Information

• do not use if seal over tube opening has been punctured or cannot be seen
• store at room temperature 15°-30°C (59°-86°F). Avoid heat over 30°C or 86°F.