FDA Label for Femmesil Maximum Strength
View Indications, Usage & Precautions
Femmesil Maximum Strength Product Label
The following document was submitted to the FDA by the labeler of this product Aidance Skincare & Topical Solutions, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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, cera alba (organic beeswax), jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, tea tree oil, zinc oxide.
Otc - Questions
Questions? 877-4-AIDANCE
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