24909-203 femmesil Cream

Manufacturer
Aidance Skincare & Topical Solutions, LLC
Effective date
2024-05-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:13:17

Label at a glance#

ProductFemmesil
Active ingredientCLOTRIMAZOLE
Label structure14 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

Purpose

OTC - PURPOSE SECTION

Vaginal Antifungal

Use

INDICATIONS & USAGE SECTION

Treats vaginal yeast infections.

Warnings

WARNINGS SECTION

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.

OTC - ASK DOCTOR SECTION

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.

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Other Information

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions?401-432-7750

PRINCIPAL DISPLAY PANEL - 50g Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

femmesil Cream 50g Tubefemmesil Cream 50g Tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309368clotrimazole 1 % Vaginal CreamPSN3
309368clotrimazole 10 MG/ML Vaginal CreamSCD3
309368clotrimazole 1 % Vaginal CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLOTRIMAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24909-203-25Femmesil25 g in 1 BOTTLECREAM253
24909-203-25Femmesil1 in 1 CARTONCREAM13
24909-203-50Femmesil50 g in 1 TUBECREAM503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24909-203FEMMESIL (CLOTRIMAZOLE) CREAM [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]3Current NDC, Legacy NDC, 3 package rows20240604_efddad82-9dc7-4cd9-b33c-7e85f30d992e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H651
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H651
BENTONITEINACTIVE INGREDIENTA3N5ZCN45C1
JOJOBA OILINACTIVE INGREDIENT724GKU717M1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH1
SILVER OXIDEINACTIVE INGREDIENT897WUN6G6T1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G1
WATERINACTIVE INGREDIENT059QF0KO0R1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54Z1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24909-20324909-203-25, 24909-203-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ZINC OXIDEZINC OXIDESOI2LOH54ZLOTION / TOPICAL16 %w/wExact identifier — unii+route
3 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZLOTION / TOPICAL16 %w/wExact identifier — unii+route
3 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CCREAM / TOPICAL4.1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZLOTION / TOPICAL16 %w/wExact identifier — unii+route
3 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CCREAM / TOPICAL4.1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CCREAM / TOPICAL4.1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route
6 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FemmesilCLOTRIMAZOLEAidance Skincare & Topical Solutions, LLCefddad82-9dc7-4cd9-b33c-7e85f30d992e2024-05-24WarningsExact identifier
ndc (package): 24909-203-50
ndc (package): 24909-203-25
ndc (product): 24909-203
ndc11 (package): 24909020350
ndc11 (package): 24909020325
spl id: 193aaeac-5c4f-3cdc-e063-6394a90a1f02
spl set id: efddad82-9dc7-4cd9-b33c-7e85f30d992e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.