24909-202 Femmesil

24909-202 Femmesil
SPL v5
SPL
SPL Set ID d8b01fe1-4465-497b-909e-f51f31fdf833
Route
TOPICAL
Published
Effective Date 2018-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Cottonseed Oil Jojoba Oil Magnesium Oxide Peppermint Oil Silver Oxide Stearic Acid Tea Tree Oil White Wax Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2012-09-07 Until 2027-06-13

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 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.



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 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.

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

beeswax (organic), bentonite clay, cotton seed oil, jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, stearic acid, tea tree oil, zinc oxide.

Keep Out of Reach of Children.

If swallowed, call poison control or seek medical help

Principal Display Panel 28g Tube


Structured Label Content

Use.

Treats vaginal yeast infections

Section 50566-9 (50566-9)

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.



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 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.

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

beeswax (organic), bentonite clay, cotton seed oil, jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, stearic acid, 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 Tube (PRINCIPAL DISPLAY PANEL - 28g Tube)


Advanced Ingredient Data


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