Label: FEMMESIL MAXIMUM STRENGTH- miconazole nitrate ointment

  • NDC Code(s): 24909-202-28, 24909-202-29
  • Packager: Aidance Skincare & Topical Solutions, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 24, 2024

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  • 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

    Ask 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 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.
  • PREGNANCY OR BREAST FEEDING

    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

    Questions?877-4-AIDANCE

  • PRINCIPAL DISPLAY PANEL - 28g Tube

    Carton Image

  • INGREDIENTS AND APPEARANCE
    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)