Femmesil Creme
FDA Label NDC 24909-201

Full FDA labeling including 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 Creme (NDC 24909-201). 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 use if 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 if symptoms 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

Bentonite clay, distilled water, jojoba seed oil, peppermint oil, silver oxide, tea tree oil, zinc oxide.

Otc - Questions

Questions? 877-4-AIDANCE

Principal Display Panel - 28G Carton

Carton Image (Femmesil Max Creme Box Noapp 28g 040512)

Carton Image (Femmesil Max Creme Box Noapp 28g 040512)

* Please review the disclaimer below.