FDA.reportPublic FDA data

CAREALL Miconazole Nitrate

Manufacturer
New World Imports, Inc
Effective date
2025-12-01
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:18:57

Label at a glance#

ProductCAREALL Miconazole Nitrate
Active ingredientMICONAZOLE NITRATE
Label structure8 sections

Indications and uses

Proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm. For effective relief of itching, scaling, burning and discomfort

Dosage and administration

wash affected area and dry thoroughly apply a thin layer of the 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 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 itc...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

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 right away (1-800-222-1222).

Uses

INDICATIONS & USAGE SECTION

  • Proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm.
  • For effective relief of itching, scaling, burning 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 productavoide contact with eyes

Stop use and ask doctor if

  • irritation occurs
  • there is no improvement within 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 of the 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 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
  • not effective on the scalp or nails

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ceteareth 20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Purified Water, White Petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AFMC1 Carton LabelAFMC1 Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998483miconazole nitrate 2 % Topical CreamPSN7
998483miconazole nitrate 20 MG/ML Topical CreamSCD7
998483miconazole nitrate 2 % Topical CreamSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MICONAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130085317008673GTIN-13: 0085317008673
EAN-13: 0085317008673
GTIN-12: 085317008673
UPC-A: 085317008673
GTIN storage (14 digits): 00085317008673		AFMC1 Carton Label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51824-078-01CAREALL Miconazole Nitrate28 g in 1 TUBECREAM287

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51824-078-01GM - Gram51824-0783e2179a3-5119-458d-afaa-8b9bd887439712021-08-05

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
51824-07851824-078-01

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
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHLOROCRESOL36W53O7109IACT
MINERAL OILT5L8T28FGPIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB

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 Miconazole NitrateMICONAZOLE NITRATENew World Imports, Incbed775be-8bcb-44c2-9b9f-8bb25b4b24532025-12-01WarningsExact identifier
ndc (package): 51824-078-01
ndc (product): 51824-078
ndc11 (package): 51824007801
spl id: 44ebdc80-6f2e-836c-e063-6394a90aeba7
spl set id: bed775be-8bcb-44c2-9b9f-8bb25b4b2453

Reported adverse events (FAERS/openFDA)#

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