1230-MN, 1233-MN Antifungal Cream

Manufacturer
Dynarex Corporation
Effective date
2026-03-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:51:05

Label at a glance#

ProductAntifungal
Active ingredientMICONAZOLE NITRATE
Label structure10 sections

Indications and uses

• For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruis), and ringworm (tinea corporis) • Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, chafing associated with jock itch, and 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 joc...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate USP 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

• For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruis), and ringworm (tinea corporis)

• Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, chafing associated with jock itch, and 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

• Avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

• Irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor for athlete's foot and ringworm.

• Irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor 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 (1-800-222-1222) 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 controlled room temperature 20°-25°C (68°-77°F)

• Tamper evident. Do not use if seal is damaged.

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetostearyl alcohol, chlorocresol, edetate disodium, light mineral oil, macrogol cetostearyl ether, propylene glycol, purified water, sodium phosphate dibasic dihydrate, sodium phosphate monobasic dihydrate, white petrolatum, zinc oxide

Questions?

OTC - QUESTIONS SECTION

1-888-Dynarex Monday-Friday, 9am-5pm EST

Label 1230-MN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1230-MN_BX_MASTER1230-MN_BX_MASTER

Label 1233-MN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1233-MN_IN_MASTER1233-MN_IN_MASTER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998483miconazole nitrate 2 % Topical CreamPSN1
998483miconazole nitrate 20 MG/ML Topical CreamSCD1
998483miconazole nitrate 2 % Topical CreamSY1

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-130840117346697GTIN-13: 0840117346697
EAN-13: 0840117346697
GTIN-12: 840117346697
UPC-A: 840117346697
GTIN storage (14 digits): 00840117346697
1230-MN_BX_MASTER_R251027-2.jpg
BarcodeEAN-130840117346710GTIN-13: 0840117346710
EAN-13: 0840117346710
GTIN-12: 840117346710
UPC-A: 840117346710
GTIN storage (14 digits): 00840117346710
1233-MN_IN_MASTER_R251020-6.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
67777-710-01Antifungal5 g in 1 PACKETCREAM51
67777-710-01Antifungal144 in 1 BOXCREAM1441
67777-710-02Antifungal2 in 1 CASECREAM21
67777-710-03Antifungal113 g in 1 TUBECREAM1131
67777-710-04Antifungal6 in 1 BOXCREAM61
67777-710-05Antifungal4 in 1 CASECREAM41

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-71067777-710-01, 67777-710-02, 67777-710-03, 67777-710-04, 67777-710-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
AntifungalMICONAZOLE NITRATEDynarex Corporation4d384385-f3c5-09ba-e063-6394a90aec7f2026-03-17WarningsExact identifier
ndc (package): 67777-710-02
ndc (package): 67777-710-03
ndc (package): 67777-710-01
ndc (package): 67777-710-05
ndc (package): 67777-710-04
ndc (product): 67777-710
ndc11 (package): 67777071003
ndc11 (package): 67777071002
ndc11 (package): 67777071005
ndc11 (package): 67777071004
ndc11 (package): 67777071001
spl id: 4d384385-f3c6-09ba-e063-6394a90aec7f
spl set id: 4d384385-f3c5-09ba-e063-6394a90aec7f

Reported adverse events (FAERS/openFDA)#

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