FDA.reportPublic FDA data

Clotrimazole Vaginal Cream, USP

Manufacturer
TOP CARE (Topco Associates LLC)
Effective date
2024-11-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:37:14

Label at a glance#

ProductClotrimazole
Active ingredientCLOTRIMAZOLE
Label structure10 sections

Indications and uses

treats most athlete's foot, jock itch, and ringworm relieves itching, burning, cracking, scaling, and discomfort

Dosage and administration

wash the affected area and dry thoroughly apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctor supervise children in the use of this product for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily for athlete's foot and ringworm, use daily for 4 weeks; for jo...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole, USP 1%

)

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • treats most athlete's foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling, and discomfort

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age, unless directed by a doctor.

When using this product,

SPL UNCLASSIFIED SECTION

avoid contact with the eyes.

Stop use and ask a doctor if

SPL UNCLASSIFIED SECTION

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foots and ringworm) or within 2 weeks (for jock itch)

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

  • wash the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctor
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition lasts longer, contact a doctor
  • this product is not effective on the scalp or nails

Other information

OTHER SAFETY INFORMATION

  • store at room temperature 20º-25ºC (68º-77ºF)
  • before using any medication, read all label directions. Keep carton, it contains 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

Question or comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-423-0139

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO LOTRIMIN® AF ATHLETE'S FPPT CREAM ACTIVE INGREDIENT*

Athlete's Foot Cream

Cure Most Athlete's Foot

RELIEVES:

  • Itching
  • Burning
  • Cracking
  • Scaling
  • Proven Clinically Effective in the Treatment of Most Athlete's Foot
  • Soothes Itching and Burning

NET WT. OZ (g)

*This product is not manufactured or distributed by Bayer HealthCare LLC., distributor of Lotrimin® AF Athlete's Foot Cream.

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

www.topcarebrand.com

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TOPCARE HEALTH Athlete's Foot Cream
TOPCARE HEALTH Athlete's Foot Cream

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-508-01Clotrimazole28 g in 1 TUBECREAM284
36800-508-01Clotrimazole1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-508CLOTRIMAZOLE CREAM [TOP CARE (TOPCO ASSOCIATES LLC)]4Legacy NDC, 2 package rows20241115_cdb619ea-29a3-4c17-a6ec-8ff0b2f31ab4.zip

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
36800-50836800-508-01

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
b5f02aa7-e582-40f1-a912-b43c32b64bd6cdb619ea-29a3-4c17-a6ec-8ff0b2f31ab42024-11-13WarningsExact identifier
spl id: b5f02aa7-e582-40f1-a912-b43c32b64bd6
spl set id: cdb619ea-29a3-4c17-a6ec-8ff0b2f31ab4

Reported adverse events (FAERS/openFDA)#

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