24909-050 Femmesil Ultra Therapy Max

24909-050 Femmesil Ultra Therapy Max
SPL v1
SPL
SPL Set ID 3d36794a-07d0-860c-e063-6294a90a6e8f
Route
TOPICAL
Published
Effective Date 2025-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Magnesium Oxide Jojoba Oil Cottonseed Oil Peppermint Oil Coconut Oil Beeswax Palm Oil Zinc Oxide Silver Stearate Tea Tree Oil Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-25

Description

Clotrimazole

Purpose

Vaginal Antifungal


Medication Information

Purpose

Vaginal Antifungal

Description

Clotrimazole

Uses

Treats vaginal yeast infections.

Section 50565-1

Keep out of reach of children.

Section 51945-4

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 60561-8

If swallowed, call poison control or seek medical help.

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, either shoulder, or a foul-smelling vaginal discharge.You should see a doctor for treatment of these symptoms.

Ask a 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 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 and ask a doctor if symptoms do not improve in 3 days; symptoms last more than 7 days; you get a rash or hives, 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 older: femmesil may be used topically (outside the vaginal area) or intravaginally. Squeeze a small amount of ointment onto fingertip. Apply 2 to 3 times daily for up to 3 days or longer as needed. Store at room temperature.

Questions?

401-432-7750 or www.aidance.com

Active Ingredient

Clotrimazole

Inactive Ingredients

beeswax, coconut oil (organic), cottonseed oil*, jojoba oil, magnesium oxide, MCT oil, peppermint oil, silver stearate, tea tree oil, vegetable stearic acid (naturally sourced)*, zinc oxide

*may contain this ingredient


Structured Label Content

Uses

Treats vaginal yeast infections.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Section 60561-8 (60561-8)

If swallowed, call poison control or seek medical help.

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, either shoulder, or a foul-smelling vaginal discharge.You should see a doctor for treatment of these symptoms.

Ask a 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 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 and ask a doctor if symptoms do not improve in 3 days; symptoms last more than 7 days; you get a rash or hives, 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 older: femmesil may be used topically (outside the vaginal area) or intravaginally. Squeeze a small amount of ointment onto fingertip. Apply 2 to 3 times daily for up to 3 days or longer as needed. Store at room temperature.

Questions?

401-432-7750 or www.aidance.com

Active Ingredient

Clotrimazole

Inactive Ingredients

beeswax, coconut oil (organic), cottonseed oil*, jojoba oil, magnesium oxide, MCT oil, peppermint oil, silver stearate, tea tree oil, vegetable stearic acid (naturally sourced)*, zinc oxide

*may contain this ingredient


Advanced Ingredient Data


Raw Label Data

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