Your browser does not support JavaScript! FEMMESIL CREME MAXIMUM STRENGTH (MICONAZOLE NITRATE) CREAM [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]
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FEMMESIL CREME MAXIMUM STRENGTH (miconazole nitrate) cream
[Aidance Skincare & Topical Solutions, LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

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 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 Information

Store at room temperature.

Inactive Ingredients

bentonite clay, distilled water, jojoba seed oil, peppermint oil, silver oxide, tea tree oil, zinc oxide.

Questions? 877-4-AIDANCE

PRINCIPAL DISPLAY PANEL - 28g Carton

Carton Image

FEMMESIL CREME  MAXIMUM STRENGTH
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:24909-201
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 
PEPPERMINT OIL 
SILVER OXIDE 
TEA TREE OIL 
WATER 
ZINC OXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-201-281 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/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-201), label(24909-201)

Revised: 9/2012
 
Aidance Skincare & Topical Solutions, LLC

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