Label: FEMMESIL- clotrimazole cream

  • NDC Code(s): 24909-203-25, 24909-203-50
  • Packager: Aidance Skincare & Topical Solutions, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 24, 2024

If you are a consumer or patient please visit this version.

  • 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 DOCTOR

    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

    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

    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.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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

    Questions?401-432-7750

  • PRINCIPAL DISPLAY PANEL - 50g Tube

    femmesil Cream 50g Tube

  • INGREDIENTS AND APPEARANCE
    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)