Active Ingredient
Clotrimazole
Femmesil Ultra Therapy Ointment
FDA Label NDC 24909-050
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 Scientific, Inc. for the product Femmesil Ultra Therapy (NDC 24909-050). 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, otc - pregnancy or breast feeding, otc - keep out of reach of children, other safety information, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Vaginal Antifungal
Uses
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.
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.
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.
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Other Safety Information
If swallowed, call poison control or seek medical help.
Directions
Children under 12: Ask a physician. Adults and children 12 years and older: femmesil may be used topically (outside the vaginal area) or intravaginally. Squeeze a small amount of ointment onto fingertip. Apply 2 to 3 times daily for up to 3 days or longer as needed. Store at room temperature.
Inactive Ingredients
beeswax, coconut oil (organic), cottonseed oil*, jojoba oil, magnesium oxide, MCT oil, peppermint oil, silver stearate, tea tree oil, vegetable stearic acid (naturally sourced)*, zinc oxide
*may contain this ingredient
Questions?
401-432-7750 or www.aidance.com
* Please review the disclaimer below.
