FDA.reportPublic FDA data

Clotrimazole Vaginal Cream, USP

Manufacturer
Strategic Sourcing Services LLC
Effective date
2026-01-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:53:19

Label at a glance#

ProductClotrimazole
Active ingredientCLOTRIMAZOLE
Label structure10 sections

Indications and uses

treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection

Dosage and administration

before using this product, read the enclosed educational brochure for complete directions and information adults and children 1 years of age and over: vaginal cream : insert one applicatorful of cream into the vagina at bedtime for 7 days in a row. Wash applicator after each use. external cream : use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole, USP 1% (50 mg in each applicatorful)

Clotrimazole, USP 1% (external cream)

Purpose

OTC - PURPOSE SECTION

Vaginal antifungal

Vaginal antifungal

Uses

INDICATIONS & USAGE SECTION

  • treats vaginal yeast infections
  • relieves external itching and irritation due to a vaginal yeast infection

Warnings

WARNINGS SECTION

For external use only.

Do not use

SPL UNCLASSIFIED SECTION

if you have never had a vaginal yeast infection diagnosed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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,

OTC - WHEN USING SECTION

  • do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs).
  • do not have vaginal intercourse
  • mild increase in vaginal burning, itching or irritation may occur
  • if you do not get complete relief, ask a doctor before using another product

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms do not get better 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 dischage

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • before using this product, read the enclosed educational brochure for complete directions and information
  • adults and children 1 years of age and over:
    • vaginal cream: insert one applicatorful of cream into the vagina at bedtime for 7 days in a row. Wash applicator after each use.
    • external cream: use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days as needed.
  • children under 12 years of age: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
  • do not use if foil seal on tube opening is broken or missing
  • do not purchase if carton is open
  • store at room temperature 20º to 25ºC (68º to 77ºF)
  • before using any medication, read all label directions. Keep carton, it contain important information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

7-DAY TREATMENT

Clotrimazole

Vaginal Cream, USP 1%

VAGINAL ANTIFUNGAL (with 1 reusable applicator)

  • Clotrimazole Vaginal Cream Can Kill The Yeast That May Cause Vaginal Infection
  • Cures Most Vaginal Yeast Infections
  • 1 Reusable Applicator
  • Educational Pamphlet Enclosed

Distributed by: McKesson Corp.,

via Strategic Sourcing Services LLC.

Memphis, TN 38141

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FOSTER & THRIVE Vaginal Cream
FOSTER & THRIVE Vaginal Cream

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130010939959980GTIN-13: 0010939959980
EAN-13: 0010939959980
GTIN-12: 010939959980
UPC-A: 010939959980
GTIN storage (14 digits): 00010939959980		clotrimazole-1-percent-cream-ene-delisted-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1228-1GM - Gram70677-1228afa2a517-4358-4fb1-bcbe-5202e47e80c212024-07-12

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70677-122870677-1228-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CLOTRIMAZOLEG07GZ97H65ACTIB
BENZYL ALCOHOLLKG8494WBHIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ESTERS WAXD072FFP9GUIACT
OCTYLDODECANOL461N1O614YIACT
POLYSORBATE 60CAL22UVI4MIACT
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT

Source Document#

Source XML

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
b3366848-77f9-443d-9116-8eaf16c7b51ed5fe1c1a-900b-4439-80fa-3b0fc3ba142e2026-01-27WarningsExact identifier
spl id: b3366848-77f9-443d-9116-8eaf16c7b51e
spl set id: d5fe1c1a-900b-4439-80fa-3b0fc3ba142e

Reported adverse events (FAERS/openFDA)#

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