FEMMESIL ULTRA THERAPY- clotrimazole ointment

femmesil Ultra Therapy by

Drug Labeling and Warnings

femmesil Ultra Therapy by is a Otc medication manufactured, distributed, or labeled by Aidance Scientific, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Clotrimazole

Purpose

Vaginal Antifungal

Uses

Treats vaginal yeast infections.

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.

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

Keep out of reach of children.

If swallowed, call poison control or seek medical help.

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.

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

Questions?

401-432-7750 or www.aidance.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FEMMESIL ULTRA THERAPY 
clotrimazole ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
JOJOBA OIL (UNII: 724GKU717M)
COTTONSEED OIL (UNII: H3E878020N)
PEPPERMINT OIL (UNII: AV092KU4JH)
COCONUT OIL (UNII: Q9L0O73W7L)
BEESWAX (UNII: 2ZA36H0S2V)
PALM OIL (UNII: 5QUO05548Z)
ZINC OXIDE (UNII: SOI2LOH54Z)
SILVER STEARATE (UNII: 4H6PCL92ZN)
TEA TREE OIL (UNII: VIF565UC2G)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-050-28	28 g in 1 TUBE; Type 0: Not a Combination Product	08/25/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	08/25/2025

Labeler - Aidance Scientific, Inc. (018950611)

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Scientific, Inc.		018950611	manufacture(24909-050)