FEMMESIL CREME MAXIMUM STRENGTH- miconazole nitrate cream

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.
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.
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.
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.

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.
QUESTIONS

Questions? 877-4-AIDANCE
PRINCIPAL DISPLAY PANEL - 28g Carton

INGREDIENTS AND APPEARANCE

FEMMESIL CREME MAXIMUM STRENGTH
miconazole nitrate cream

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2.0 g in 100 g

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	09/07/2012

Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)

Name	Address	ID/FEI	Business Operations
Establishment
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-201) , label(24909-201)