FDA.reportPublic FDA data

Perrigo Clotrimazole Cream USP, 1% Drug Facts

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-06-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:13:25

Label at a glance#

Productclotrimazole
Active ingredientCLOTRIMAZOLE
Label structure9 sections

Indications and uses

cures most athlete’s foot, jock itch and ringworm relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Dosage and administration

wash the affected area and dry thoroughly apply a thin layer over affected area twice daily (morning and night) 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 conditio...

Storage and handling

store at 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

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 which accompany these conditions

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age unless directed by a doctor

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes

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)

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4225-52024-06-06C16284748780-1ba0f9c33-57a5-a910-e053-dadaa90a0b85Perrigo Clotrimazole Cream USP, 1% Drug Facts
68071-4225-52023-01-30C16284748780-1ba0f9c33-57a5-a910-e053-dadaa90a0b85Perrigo Clotrimazole Cream USP, 1% Drug Facts
68071-4225-52021-02-15C16284748780-1ba0f9c33-57a5-a910-e053-dadaa90a0b85Perrigo Clotrimazole Cream USP, 1% Drug Facts
68071-4225-52021-01-29C16284748780-1ba0f9c33-57a5-a910-e053-dadaa90a0b85Perrigo Clotrimazole Cream USP, 1% Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4225-5clotrimazole15 g in 1 BOXCREAM155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4225CLOTRIMAZOLE CREAM [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 1 package rows20240608_627375fb-2f20-16bc-e053-2a91aa0a1542.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-434-01GM - Gram45802-434d14ca4ba-e10d-4e66-9753-635847aed1a612012-07-24
45802-434-11GM - Gram45802-434a0b1e4f4-5f17-41be-ab4f-f972953bca2e12012-07-24

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68071-422568071-4225-5
45802-434

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ESTERS WAXD072FFP9GUIACT
OCTYLDODECANOL461N1O614YIACT
POLYSORBATE 60CAL22UVI4MIACT
WATER059QF0KO0RIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
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
clotrimazoleCLOTRIMAZOLEPadagis Israel Pharmaceuticals Ltd3dcd0158-ec51-4fa7-a26a-02c2926156c02026-01-22WarningsExact identifier
ndc (product): 45802-434
clotrimazoleCLOTRIMAZOLENuCare Pharmaceuticals,Inc.627375fb-2f20-16bc-e053-2a91aa0a15422024-06-06WarningsExact identifier
ndc (package): 68071-4225-5
ndc (product): 68071-4225
ndc11 (package): 68071422505
spl id: 1a3c5c49-b373-1318-e063-6394a90a47b6
spl set id: 627375fb-2f20-16bc-e053-2a91aa0a1542

Reported adverse events (FAERS/openFDA)#

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