24909-203 Femmesil Cream

24909-203 Femmesil Cream
SPL v3
SPL
SPL Set ID efddad82-9dc7-4cd9-b33c-7e85f30d992e
Route
TOPICAL
Published
Effective Date 2018-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Cottonseed Oil Water Cetostearyl Alcohol Jojoba Oil Peppermint Oil Shea Butter Silver Stearate Sorbic Acid Tea Tree Oil Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2014-11-30 Until 2017-06-01

Description

Clotrimazole 1%

Purpose

Vaginal Antifungal


Medication Information

Purpose

Vaginal Antifungal

Description

Clotrimazole 1%

Use

Treats vaginal yeast infections.

Section 50565-1

Keep out of reach of children. If swallowed, call poison control or seek medical help.

Section 50566-9

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.

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 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.

Section 53413-1

Questions?401-432-7750

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, 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 to 3 times daily for up to 3 days or longer as needed.

Active Ingredient

Clotrimazole 1%

Other Information

Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.

Inactive Ingredients

cottonseed oil, purified water, emulsifying wax, jojoba oil, peppermint oil, shea butter, silver stearate, sorbic acid, tea tree oil, zinc oxide

Principal Display Panel 50g Tube


Structured Label Content

Use

Treats vaginal yeast infections.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, call poison control or seek medical help.

Section 50566-9 (50566-9)

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.

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 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.

Section 53413-1 (53413-1)

Questions?401-432-7750

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, 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 to 3 times daily for up to 3 days or longer as needed.

Active Ingredient

Clotrimazole 1%

Other Information

Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.

Inactive Ingredients

cottonseed oil, purified water, emulsifying wax, jojoba oil, peppermint oil, shea butter, silver stearate, sorbic acid, tea tree oil, zinc oxide

Principal Display Panel 50g Tube (PRINCIPAL DISPLAY PANEL - 50g Tube)


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