FDA.reportPublic FDA data

CR-1232

Manufacturer
Cardinal Health | Dynarex Corporation
Effective date
2026-09-15
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
daily-update
Hydrated at
2026-09-18 01:00:54

Label at a glance#

ProductMiconazole Nitrate Cream USP, 2%
Active ingredientMICONAZOLE NITRATE
Label structure9 sections

Indications and uses

For the treatment of most athlete's foot, tinea pedis, jock itch, tinea crusis, ringworm, tinea corporis Relieves itching, scaling, burning, 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 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 dai...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of most athlete's foot, tinea pedis, jock itch, tinea crusis, ringworm, tinea corporis
  • Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet

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
  • for diaper rash

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 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

If swallowed, get medical help or contact a Poison Control Center (1800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the 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 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

OTHER SAFETY INFORMATION

Store at 15° -30°C (59° -86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cetostearyl Alcohol, Chlorocresol, Disodium EDTA, Disodium Hydrogen Phosphate Dihydrate, Light Liquid Paraffin, Macrogol Cetostearyl Ether, Propylene Glycol, Purified Water, Sodium Dihydrogen Phosphate Dihydrate, White Soft Paraffin

Questions

OTC - QUESTIONS SECTION

1-888-DYNAREX

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CR-1232 Primary Display PanelCR-1232 Primary Display Panel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0340-1GM - Gram70000-034009378a1a-cacb-4618-b22f-d9c9c85d5c4012019-08-06

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-034070000-0340-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICONAZOLE NITRATEVW4H1CYW1KACTIB
PETROLATUM4T6H12BN9UIACT
SODIUM PHOSPHATE DIBASIC DIHYDRATE94255I6E2TIACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
CETEARETH-127V4MR24V5PIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHLOROCRESOL36W53O7109IACT
LIGHT MINERAL OILN6K5787QVPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102025-11-25full-release2026-06-01 01:18:05

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
4470ed81-4c10-ba4d-e063-6294a90ad130776ca76a-a6cc-5238-e053-2a91aa0abfcb2025-11-25WarningsExact identifier
spl set id: 776ca76a-a6cc-5238-e053-2a91aa0abfcb

Reported adverse events (FAERS/openFDA)#

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