Clotrimazole cream USP, 1%

Manufacturer
Proficient Rx LP
Effective date
2026-10-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-30 01:02:35

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

Relabeled by:

Proficicient Rx LP

Thaousand Oaks, CA 91320

Made in China

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82804-324-15
82804-324-15

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130382804324156GTIN-13: 0382804324156
EAN-13: 0382804324156
GTIN-12: 382804324156
UPC-A: 382804324156
GTIN storage (14 digits): 00382804324156
image-01.jpg
Data codeData Matrix010038280432415621MASTER<GS>171000000image-01.jpg
Data codeData MatrixXC032415*82804-324-15*14.17 g*00000*00536-1265-11*000000*MASTERimage-01.jpg

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
82804-32482804-324-15
0536-1265

Ingredients#

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

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

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
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.