FEMMESIL MAXIMUM STRENGTH- miconazole nitrate ointment 
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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Drug Facts

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

beeswax (organic), bentonite clay, cotton seed oil, jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, stearic acid, tea tree oil, zinc oxide.

Questions? 877-4-AIDANCE

PRINCIPAL DISPLAY PANEL - 25g Tube

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FEMMESIL  MAXIMUM STRENGTH
miconazole nitrate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-202
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENTONITE (UNII: A3N5ZCN45C)  
COTTONSEED OIL (UNII: H3E878020N)  
JOJOBA OIL (UNII: 724GKU717M)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SILVER OXIDE (UNII: 897WUN6G6T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TEA TREE OIL (UNII: VIF565UC2G)  
WHITE WAX (UNII: 7G1J5DA97F)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-202-281 in 1 CARTON09/07/2012
128 g in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:24909-202-2928 g in 1 TUBE; Type 0: Not a Combination Product12/31/2018
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(24909-202) , label(24909-202)

Revised: 12/2018
Document Id: f0e4459a-7455-41e8-a426-5d1f0ebb4465
Set id: d8b01fe1-4465-497b-909e-f51f31fdf833
Version: 3
Effective Time: 20181229
 
Aidance Skincare & Topical Solutions, LLC