Clotrimazole Cream 1%

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2025-02-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:40:52

Label at a glance#

ProductClotrimazole Cream 1%
Active ingredientCLOTRIMAZOLE
Label structure10 sections

Indications and uses

• For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) • Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch or itching, burning feet

Dosage and administration

• Clean the affected area and dry thoroughly. Apply a thin layer of cream 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 • Fo...

Storage and handling

• Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal • Store at room temperature • Preserve in tight containers • See crimp of tube or carton for Lot Number and Expiry Date

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

• For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
• Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch or itching, burning feet

Warnings

WARNINGS SECTION

For external use only

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

When using this product • avoid contact with the eyes

Stop use and ask a doctor if • irritation occurs • there is no improvement within 2 weeks when used for the treatment of jock itch • there is no improvement within 4 weeks when used for athlete’s foot or ringworm

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Clean the affected area and dry thoroughly. Apply a thin layer of cream 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 persists longer, consult a doctor. This product is not effective on the scalp or nails

Other information

STORAGE AND HANDLING SECTION

• Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal • Store at room temperature • Preserve in tight containers • See crimp of tube or carton for Lot Number and Expiry Date

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cetostearyl Alcohol, Macrogol Cetostearyl Ether, Methylparaben, Mineral Oil, Propylene Glycol, Propylparaben, Purified Water, White Petrolatum

Questions or comments?

OTC - QUESTIONS SECTION

718-502-6610 between 9 am to 4 pm EST, Monday-Friday.

SPL UNCLASSIFIED SECTION

Cures Most Athlete's Foot

Compared to the active ingredient in Lotrimin ® ​AF*

Relieves Itching and Burning Sensation. Relieves from Cracking and Scaling. Greaseless and non-staining.

*This product is not affiliated with, manufactured by, or produced by the makers or owners of Lotrimin ® AF

Distributed by:

EzriCare, LLC

Lakewood, NJ

www.EzriCare.com

Made in India

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3416-32025-03-04C16284748780-12cef2736-915f-d83d-e063-dadaa90ab31fEZRI CARE TM Clotrimazole Cream USP 1%
68071-3416-32025-01-30C16284748780-12cef2736-915f-d83d-e063-dadaa90ab31fEZRI CARE TM Clotrimazole Cream USP 1%

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3416CLOTRIMAZOLE CREAM 1% (CLOTRIMAZOLE) CREAM [NUCARE PHARMACEUTICALS,INC.]2Unmatched20250306_fc8b8b12-80c7-d4df-e053-6394a90ad437.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79503-105-30GM - Gram79503-10566b69b89-4095-4f57-9011-f42b62b9942e12022-05-04

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68071-341668071-3416-3
79503-105

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
2d584e7b-d293-0750-e063-6394a90a1985fc8b8b12-80c7-d4df-e053-6394a90ad4372025-02-04WarningsExact identifier
spl id: 2d584e7b-d293-0750-e063-6394a90a1985
spl set id: fc8b8b12-80c7-d4df-e053-6394a90ad437

Reported adverse events (FAERS/openFDA)#

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