FDA.reportPublic FDA data

Rugby Clotrimazole Antifungal Cream

Manufacturer
Rugby Laboratories | Trifecta Pharmaceuticals USA LLC
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:47:41

Label at a glance#

ProductRugby Clotrimazole Antifungal Cream
Active ingredientCLOTRIMAZOLE
Label structure14 sections

Indications and uses

Cures athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Dosage and administration

Wash the affected area and dry thoroughly. ● Apply a thin layer of this 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 the 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...

Storage and handling

store at controlled room temperature 15°-30°C (59°- 86°F) Close cap tightly after use.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole USP 1% w/w

Purpose

OTC - PURPOSE SECTION

Antifungal Cream

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

Cures athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Warnings

WARNINGS SECTION

● For external use only

● Do not use on children under 2 years of age unless directed by a doctor.

● Avoid contact with eyes.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wash the affected area and dry thoroughly.

● Apply a thin layer of this 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 the 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 conditions persists longer, consult a doctor.

● This product is not effective on the scalp or nails.

Stop Use and ask a doctor if

OTC - DO NOT USE SECTION

  • Irritation occurs
  • There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Dimethyl Sulfoxide, Ethylparaben, Glycerin, Glyceryl Stearate SE, Laureth-23, Light Mineral Oil, Petrolatum, Stearyl Alcohol, Water

Other Information

STORAGE AND HANDLING SECTION

  • store at controlled room temperature 15°-30°C (59°- 86°F)
  • Close cap tightly after use.

Other Information

SPL UNCLASSIFIED SECTION

Clotrimazole Antifungal Cream is not manufactured or distributed by Bayer, owners of the registered trademark Lotrimin®AF.

Questions

OTC - QUESTIONS SECTION

Keep carton for complete Drug Facts

Call 1-800-645-2158

Distributed by:

RUGBY® LABORATORIES

17177 N. Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Made in China

Packaging and Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

370816 RUGBY CLOTRIMAZOLE CREAM 1 PERCENT 1.6OZ 011722 CDER370816 RUGBY CLOTRIMAZOLE CREAM 1 PERCENT 1.6OZ 011722 CDER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

371174 RUGBY CLOTRIMAZOLE CREAM 1 percent 1OZ REV1023 110223 CDER371174 RUGBY CLOTRIMAZOLE CREAM 1 percent 1OZ REV1023 110223 CDER

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

371175 RUGBY CLOTRIMAZOLE CREAM 1 percent 0.5OZ REV1023 110623 CDER371175 RUGBY CLOTRIMAZOLE CREAM 1 percent 0.5OZ REV1023 110623 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN5
309367clotrimazole 10 MG/ML Topical CreamSCD5
309367clotrimazole 1 % Topical CreamSY5

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
0536-1265-11Rugby Clotrimazole Antifungal Cream1 in 1 BOXCREAM15
0536-1265-11Rugby Clotrimazole Antifungal Cream14.17 g in 1 TUBECREAM14.175
0536-1265-26Rugby Clotrimazole Antifungal Cream1 in 1 BOXCREAM15
0536-1265-26Rugby Clotrimazole Antifungal Cream45 g in 1 TUBECREAM455
0536-1265-95Rugby Clotrimazole Antifungal Cream1 in 1 BOXCREAM15
0536-1265-95Rugby Clotrimazole Antifungal Cream28 g in 1 TUBECREAM285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1265RUGBY CLOTRIMAZOLE ANTIFUNGAL CREAM (CLOTRIMAZOLE) CREAM [RUGBY LABORATORIES]5Current NDC, Legacy NDC, 6 package rows20241222_a1365bc7-b376-adca-e053-2a95a90acf19.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1265-11GM - Gram0536-12652c40d8cc-1769-4905-bac0-fb8d74d4f8a012024-05-16
0536-1265-26GM - Gram0536-126507291e9c-7da9-43e7-acb6-313ea812fd7212020-08-06
0536-1265-95GM - Gram0536-1265751a2bf8-e819-4298-90c5-4cc32e82ba9d12024-07-12

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-12650536-1265-26, 0536-1265-95, 0536-1265-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHYL SULFOXIDEYOW8V9698HIACT
ETHYLPARABEN14255EXE39IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
LAURETH-23N72LMW566GIACT
LIGHT MINERAL OILN6K5787QVPIACT
PETROLATUM4T6H12BN9UIACT
STEARYL ALCOHOL2KR89I4H1YIACT
WATER059QF0KO0RIACT
CLOTRIMAZOLEG07GZ97H65ACTIB

Source Document#

Source XML · Source PDF

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
Rugby Clotrimazole Antifungal CreamCLOTRIMAZOLERugby Laboratoriesa1365bc7-b376-adca-e053-2a95a90acf192024-12-20WarningsExact identifier
ndc (package): 0536-1265-11
ndc (package): 0536-1265-95
ndc (package): 0536-1265-26
ndc (product): 0536-1265
ndc11 (package): 00536126511
ndc11 (package): 00536126526
ndc11 (package): 00536126595
spl id: 29b43e9e-352d-2018-e063-6394a90a27f7
spl set id: a1365bc7-b376-adca-e053-2a95a90acf19

Reported adverse events (FAERS/openFDA)#

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