FEMMESIL MAXIMUM STRENGTH- miconazole nitrate ointment

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient

Miconazole Nitrate 2%.

Purpose

Vaginal Antifungal.

Use.

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

ASK DOCTOR

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.

WHEN USING

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

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.

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.

PREGNANCY OR BREAST FEEDING

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

Keep out of reach of children.

If swallowed, call poison control or seek medical help

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.

QUESTIONS

Questions? 877-4-AIDANCE

PRINCIPAL DISPLAY PANEL - 25g Tube

INGREDIENTS AND APPEARANCE

FEMMESIL  MAXIMUM STRENGTH
miconazole nitrate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENTONITE (UNII: A3N5ZCN45C)
COTTONSEED OIL (UNII: H3E878020N)
JOJOBA OIL (UNII: 724GKU717M)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
PEPPERMINT OIL (UNII: AV092KU4JH)
SILVER OXIDE (UNII: 897WUN6G6T)
STEARIC ACID (UNII: 4ELV7Z65AP)
TEA TREE OIL (UNII: VIF565UC2G)
WHITE WAX (UNII: 7G1J5DA97F)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-202-28	1 in 1 CARTON	09/07/2012
1		28 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 24909-202-29	28 g in 1 TUBE; Type 0: Not a Combination Product	12/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	09/07/2012

Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-202) , label(24909-202)