FEMMESIL CREME MAXIMUM STRENGTH - miconazole nitrate cream 
Aidance Skincare & Topical Solutions, LLC

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.

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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

When using this product

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 DRUGItem 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 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:24909-201-281 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
128 g in 1 BOTTLEThis package is contained within the CARTON (24909-201-28)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/05/2012

Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIOperations
Aidance Skincare & Topical Solutions, LLC018950611manufacture, label

Revised: 04/2012 Aidance Skincare & Topical Solutions, LLC