Femmesil Ointment
FDA Label NDC 24909-202

14 label sections · Submitted to the FDA by Aidance Skincare & Topical Solutions, Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aidance Skincare & Topical Solutions, Llc for the product Femmesil (NDC 24909-202). 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, use., warnings, otc - ask doctor, otc - when using, otc - stop use, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Miconazole Nitrate 2%.

Purpose

Vaginal Antifungal.

Use.

Treats vaginal yeast infections

Warnings

For vaginal use only. Do not useif you have never had a vaginal yeast infection diagnosed by a doctor; if you have a fever (higher than 100° F), pain in the lower abdomen, back, or either shoulder, or a foul-smelling vaginal discharge. You should see a doctor for treatment of these symptoms.

Otc - Ask Doctor

Ask 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.

Otc - When Using

When using this product

  • Do not use tampons, douches, spermicides, or other vaginal products; condoms or diaphragms may be damaged and fail to prevent sexually transmitted disease or pregnancy.
  • Do not have vaginal intercourse.
  • Mild increase in vaginal burning, itching or irritation may occur.

Otc - Stop Use

Stop use and ask a doctor ifsymptoms do not get better in 3 days; symptoms last more than 7 days; you get a rash orhives, abdominal pain, fever, chills, nausea, vomiting or a foul-smelling vaginal discharge.

Directions

Children under 12
Ask a physician
Adults and children 12 years and over
Femmesil may be used topically (outside the vaginal area) or intravaginally. Squeeze a small amount of cream onto fingertip. Apply 2-3 times daily for up to 3 days or longer, as needed.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, call poison control or seek medical help

Other Information

Store at room temperature

Inactive Ingredients

beeswax (organic), bentonite clay, cotton seed oil, jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, stearic acid, tea tree oil, zinc oxide.

Otc - Questions

Questions?877-4-AIDANCE

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