Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 72d74cbc-4abf-492a-9b60-3793c33b16c4
Route
TOPICAL
Published
Effective Date 2012-04-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2.0 g)
Inactive Ingredients
Bentonite Jojoba Oil Peppermint Oil Silver Oxide Tea Tree Oil Water Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-09-07
Description

Miconazole Nitrate 2%

Purpose

Vaginal Antifungal

Medication Information

Purpose
Vaginal Antifungal

Description

Miconazole Nitrate 2%

Use
Treats vaginal yeast infections.

Section 50566-9

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.



Section 50567-7

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.
Section 50569-3

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.
Section 53413-1

Questions? 877-4-AIDANCE



Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
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.

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.
Active Ingredient
Miconazole Nitrate 2%

Other Information
Store at room temperature.

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



Keep Out of Reach of Children.
If swallowed, call poison control or seek medical help.

Principal Display Panel 28g Carton

Structured Label Content

Use
Treats vaginal yeast infections.

Section 50566-9 (50566-9)

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.



Section 50567-7 (50567-7)

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.
Section 50569-3 (50569-3)

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.
Section 53413-1 (53413-1)

Questions? 877-4-AIDANCE



Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Purpose
Vaginal Antifungal

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.

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.
Active Ingredient
Miconazole Nitrate 2%

Other Information
Store at room temperature.

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



Keep Out of Reach of Children. (Keep out of reach of children.)
If swallowed, call poison control or seek medical help.

Principal Display Panel 28g Carton (PRINCIPAL DISPLAY PANEL - 28g Carton)

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:31.032072 · Updated: 2026-03-14T22:53:16.318838