FDA.reportPublic FDA data

RUGBY ® ANTIFUNGAL CREAM CLOTRIMAZOLE 1%

Manufacturer
Proficient Rx LP
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:07:50

Label at a glance#

ProductRUGBY ANTIFUNGAL CLOTRIMAZOLE
Active ingredientCLOTRIMAZOLE
Label structure11 sections

Indications and uses

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

Dosage and administration

• wash affected area and dry thoroughly • apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor • supervise children in 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 da...

Storage and handling

• store at 15 to 30°C (59 to 86°F) • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes.

OTC - DO NOT USE SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in 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 persists longer, consult a doctor
  • this product is not effective on scalp or nails

Other information

STORAGE AND HANDLING SECTION

  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

SPL UNCLASSIFIED SECTION

Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152

Relabeled by:
PROFICIENT RX LP
Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL - 14 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71205-738-15

Compare to the
active ingredient
of Lotrimin® AF*

Antifungal Cream
Clotrimazole 1%

Cures most athlete's foot

NET WT 0.5 OZ (14 g)

71205-738-15
71205-738-15

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN2
309367clotrimazole 10 MG/ML Topical CreamSCD2
309367clotrimazole 1 % Topical CreamSY2

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
71205-738-15RUGBY ANTIFUNGAL CLOTRIMAZOLE1 in 1 CARTONCREAM12
71205-738-15RUGBY ANTIFUNGAL CLOTRIMAZOLE14 g in 1 TUBECREAM142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-738RUGBY ANTIFUNGAL CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [PROFICIENT RX LP]2Current NDC, 2 package rows20240125_7c64553b-589c-4e65-a6f0-b2847bbbe8a6.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71205-73871205-738-15
0536-1272

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CLOTRIMAZOLEG07GZ97H65ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CETYL ALCOHOL936JST6JCNIACT
DMDM HYDANTOINBYR0546TOWIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL ALCOHOLND2M416302IACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
EDETATE TRISODIUM420IP921MBIACT

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 ANTIFUNGAL CLOTRIMAZOLECLOTRIMAZOLERugby Laboratories0b32a369-ea1c-4cb8-8ea1-07bba8f16b722025-09-16WarningsExact identifier
ndc (product): 0536-1272
RUGBY ANTIFUNGAL CLOTRIMAZOLECLOTRIMAZOLEProficient Rx LP7c64553b-589c-4e65-a6f0-b2847bbbe8a62024-01-01WarningsExact identifier
ndc (package): 71205-738-15
ndc (product): 71205-738
ndc11 (package): 71205073815
spl id: c923176e-3604-42a2-9820-6b6fbe81d578
spl set id: 7c64553b-589c-4e65-a6f0-b2847bbbe8a6

Reported adverse events (FAERS/openFDA)#

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