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
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated September 5, 2012
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- Active Ingredient
Miconazole Nitrate 2%
Treats vaginal yeast infections.
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.Close
- 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 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.Close
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. Close
- Keep out of reach of children.
If swallowed, call poison control or seek medical help.
- Other Information
Store at room temperature.
- Inactive Ingredients
bentonite clay, distilled water, jojoba seed oil, peppermint oil, silver oxide, tea tree oil, zinc oxide.
- PRINCIPAL DISPLAY PANEL - 28g Carton
- INGREDIENTS AND APPEARANCE
FEMMESIL CREME MAXIMUM STRENGTH
miconazole nitrate cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24909-201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2.0 g in 100 g Inactive Ingredients Ingredient Name Strength BENTONITE (UNII: A3N5ZCN45C) JOJOBA OIL (UNII: 724GKU717M) PEPPERMINT OIL (UNII: AV092KU4JH) SILVER OXIDE (UNII: 897WUN6G6T) TEA TREE OIL (UNII: VIF565UC2G) WATER (UNII: 059QF0KO0R) ZINC OXIDE (UNII: SOI2LOH54Z) 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)