Femmesil Maximum Strength

Dosage form: ointment
Ingredients: MICONAZOLE NITRATE 2.0g in 100g
Labeler: Aidance Skincare & Topical Solutions, LLC
NDC Code: 24909-202

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredient Miconazole Nitrate 2%

Purpose Vaginal Antifungal

UseTreats 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 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 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.

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 InformationStore 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.

Questions? 877-4-AIDANCE

PRINCIPAL DISPLAY PANEL - 28g Carton

FEMMESIL  MAXIMUM STRENGTH
miconazole nitrate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-202
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE2.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENTONITE 
JOJOBA OIL 
MAGNESIUM OXIDE 
PEPPERMINT OIL 
SILVER OXIDE 
TEA TREE OIL 
WHITE WAX 
ZINC OXIDE 
Packaging
#Item CodePackage Description
1NDC:24909-202-281 BOTTLE (BOTTLE) in 1 CARTON
128 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/07/2012
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIOperations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-202), label(24909-202)

Revised: 09/2012
 
Aidance Skincare & Topical Solutions, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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