Label: FEMMESIL CREME MAXIMUM STRENGTH- miconazole nitrate cream 

  • NDC Code(s): 24909-201-28
  • Packager: Aidance Skincare & Topical Solutions, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/12

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

  • Active Ingredient

    Miconazole Nitrate 2%
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  • Purpose

    Vaginal Antifungal
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  • Use

    Treats vaginal yeast infections.
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  • 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.

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  • 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.
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  • 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.
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  • STOP USE

    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.

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  • 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.
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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use. Close
  • Keep out of reach of children.

    If swallowed, call poison control or seek medical help.
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  • Other Information

    Store at room temperature.
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  • Inactive Ingredients

    bentonite clay, distilled water, jojoba seed oil, peppermint oil, silver oxide, tea tree oil, zinc oxide.

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  • QUESTIONS

    Questions? 877-4-AIDANCE

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  • PRINCIPAL DISPLAY PANEL - 28g Carton
  • INGREDIENTS AND APPEARANCE
    FEMMESIL CREME  MAXIMUM STRENGTH
    miconazole nitrate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:24909-201
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 2.0 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    BENTONITE  
    JOJOBA OIL  
    PEPPERMINT OIL  
    SILVER OXIDE  
    TEA TREE OIL  
    WATER  
    ZINC OXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24909-201-28 1 in 1 CARTON
    1 28 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 09/07/2012
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    Name Address ID/FEI Business Operations
    Aidance Skincare & Topical Solutions, LLC 018950611 manufacture(24909-201), label(24909-201)
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