Active Ingredient
Clotrimazole 1%
Femmesil Cream
FDA Label NDC 24909-203
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 24909-203). 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
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, either shoulder, or a foul-smelling vaginal discharge. You should see a doctor for treatment of these symptoms.
Otc - Ask 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.
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 improve in 3 days; symptoms last more than 7 days; you get a rash or hives, 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 to 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, call poison control or seek medical help.
Other Information
Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.
Inactive Ingredients
cottonseed oil, purified water, emulsifying wax, jojoba oil, peppermint oil, shea butter, silver stearate, sorbic acid, tea tree oil, zinc oxide
Otc - Questions
Questions?401-432-7750
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