FDA.reportPublic FDA data

CAREALL Clotrimazole

Manufacturer
New World Imports, Inc
Effective date
2024-10-07
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:23:09

Label at a glance#

ProductCAREALL Clotrimazole
Active ingredientclotrimazole
Label structure8 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 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 atlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Keep out of Reach of Children

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 immediately.

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.

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

When using this product avoid contact with eyes

Stop use and ask doctor if

  • irritation occurs
  • there is no improvement in 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

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 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 atlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ceteareth 20, Cetostearyl Alcohol, Methylparaben, Mineral Oil, Propylene Glycol, Propylparaben, Water, White Petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AFCL1AFCL1

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
51824-063-01CAREALL Clotrimazole28 g in 1 TUBECream2810

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51824-063CAREALL CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [NEW WORLD IMPORTS, INC]10Current NDC, Legacy NDC, 1 package rows20241009_ebc565bb-e56c-43ba-a5cb-d2fad2aafc4a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51824-063-01GM - Gram51824-0633accd27b-48a9-4928-ab2f-69b43fc4dbe212020-03-10

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
51824-06351824-063-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
clotrimazoleG07GZ97H65ACTIB
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
MINERAL OILT5L8T28FGPIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
water059QF0KO0RIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Incebc565bb-e56c-43ba-a5cb-d2fad2aafc4a2024-10-07WarningsExact identifier
ndc (package): 51824-063-01
ndc (product): 51824-063
ndc11 (package): 51824006301
spl id: 1b131084-a996-4923-9a06-f6f19072ade2
spl set id: ebc565bb-e56c-43ba-a5cb-d2fad2aafc4a

Reported adverse events (FAERS/openFDA)#

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