FDA.reportPublic FDA data

Drug Facts

Manufacturer
New World Imports, Inc
Effective date
2026-07-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-04 03:33:09

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 onchildren under 2 years of age unless directed by a doctor.

When using this productavoid 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

Benzyl Alcohol, Cetearyl Alcohol, Cetyl Palmitate, Octyldodecanol, Polysorbate 60, Sorbitan Stearate, Stearyl Alcohol, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

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
51824-12151824-121-01

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
STEARYL ALCOHOL2KR89I4H1YIACT
CETYL PALMITATE5ZA2S6B08XIACT
BENZYL ALCOHOLLKG8494WBHIACT
CETEARYL ALCOHOL2DMT128M1SIACT
SORBITAN STEARATENVZ4I0H58XIACT
POLYSORBATE 60CAL22UVI4MIACT
OCTYLDODECANOL461N1O614YIACT
WATER059QF0KO0RIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Inc561d3e64-ab9c-1074-e063-6394a90a12982026-07-08WarningsExact identifier
ndc (package): 51824-121-01
ndc (product): 51824-121
ndc11 (package): 51824012101
spl id: 561d48fe-f726-1267-e063-6294a90adbd2
spl set id: 561d3e64-ab9c-1074-e063-6394a90a1298

Reported adverse events (FAERS/openFDA)#

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