FDA.reportPublic FDA data

Rugby Clotrimazole Antifungal Cream

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2025-07-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:08:39

Label at a glance#

ProductRugby Clotrimazole Antifungal Cream
Active ingredientCLOTRIMAZOLE
Label structure12 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 f...

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

Relabeled By: Preferred Pharmaceuticals Inc.

68788-8901-2

Made in China

Packaging and Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clotrimazole Cream USP 1%
Clotrimazole Cream USP 1%

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN1
309367clotrimazole 10 MG/ML Topical CreamSCD1
309367clotrimazole 1 % Topical CreamSY1

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
68788-8901-2Rugby Clotrimazole Antifungal Cream28 g in 1 TUBECREAM281
68788-8901-2Rugby Clotrimazole Antifungal Cream1 in 1 BOXCREAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8901-2GM - Gram68788-8901639b6e63-89c0-4151-9572-d8a44cc94aed12025-11-13
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
68788-890168788-8901-2
0536-1265

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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby Clotrimazole Antifungal CreamCLOTRIMAZOLEPreferred Pharmaceuticals Inc.bd567e91-7152-4612-83e0-8e8a00c2d2c52025-07-25WarningsExact identifier
ndc (package): 68788-8901-2
ndc (product): 68788-8901
ndc11 (package): 68788890102
spl id: bd567e91-7152-4612-83e0-8e8a00c2d2c5
spl set id: bd567e91-7152-4612-83e0-8e8a00c2d2c5
Rugby Clotrimazole Antifungal CreamCLOTRIMAZOLERugby Laboratoriesa1365bc7-b376-adca-e053-2a95a90acf192024-12-20WarningsExact identifier
ndc (product): 0536-1265

Reported adverse events (FAERS/openFDA)#

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