FEMMESIL- clotrimazole cream 
Aidance Skincare & Topical Solutions, LLC

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24909-203 femmesil Cream

Active Ingredient

Clotrimazole 1%

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, either shoulder, or a foul-smelling vaginal discharge. You should see a doctor for treatment of these symptoms.

Ask a 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 improve in 3 days; symptoms last more than 7 days; you get a rash or hives, 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 to 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. May temporarily (washable) discolor skin and fabrics in sunlight.

Inactive Ingredients

cottonseed oil, purified water, emulsifying wax, jojoba oil, peppermint oil, shea butter, silver stearate, sorbic acid, tea tree oil, zinc oxide

Questions?401-432-7750

PRINCIPAL DISPLAY PANEL - 50g Tube

femmesil Cream 50g Tube

FEMMESIL 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-203
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
COTTONSEED OIL (UNII: H3E878020N)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
JOJOBA OIL (UNII: 724GKU717M)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SHEA BUTTER (UNII: K49155WL9Y)  
SILVER STEARATE (UNII: 4H6PCL92ZN)  
SORBIC ACID (UNII: X045WJ989B)  
TEA TREE OIL (UNII: VIF565UC2G)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-203-251 in 1 CARTON11/30/201406/01/2017
125 g in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:24909-203-5050 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 DrugM00511/30/2014
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-203) , label(24909-203)

Revised: 5/2024
Document Id: 193aaeac-5c4f-3cdc-e063-6394a90a1f02
Set id: efddad82-9dc7-4cd9-b33c-7e85f30d992e
Version: 3
Effective Time: 20240524
 
Aidance Skincare & Topical Solutions, LLC