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

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24909-202 femmesil

Active Ingredient

Miconazole Nitrate 2%.

Purpose

Vaginal Antifungal.

Use.

Treats vaginal yeast infections

Warnings

For vaginal use only. Do not useif 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 ifsymptoms 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 - 28g 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 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CARTON09/07/201206/01/2017
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 DrugM00509/07/2012
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-202) , label(24909-202)

Revised: 5/2024
Document Id: 193a3ca0-833f-51df-e063-6394a90ac2d7
Set id: d8b01fe1-4465-497b-909e-f51f31fdf833
Version: 4
Effective Time: 20240524
 
Aidance Skincare & Topical Solutions, LLC