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DB Antifungal foot

Manufacturer
The Magni Group Inc
Effective date
2023-10-25
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:23:25

Label at a glance#

ProductDB Antifungal foot
Active ingredientMICONAZOLE NITRATE
Label structure6 sections

Indications and uses

• Cures most tinea pedis (athlete’s foot) • Relieves itching, scaling, cracking, burning, redness; itchy, scaly skin between toes; itching, burning feet; discomfort

Dosage and administration

• Wash the 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 week...

Label contents#

Full prescribing information#

Active ingredients (in cream)

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

• Cures most tinea pedis (athlete’s foot) • Relieves itching, scaling, cracking, burning, redness; itchy, scaly skin between toes; itching, burning feet; discomfort

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • on children under 2 years of age unless directed by a doctor • For external use only
  • Avoid contact with the eyes 
  • If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• If swallowed, get medical attention, help, or contact a poison control center right away

Directions

DOSAGE & ADMINISTRATION SECTION

• Wash the 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 • This product is not effective on the scalp or nails

Inactive ingredients

INACTIVE INGREDIENT SECTION

Allium Sativum Garlic (Plant) Extract, C12-15 Alkyl Benzoate, Ceteth-20, Cetyl Alcohol, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Garcinia Indica Seed Butter, Hydroxyacetophenone, Isopropyl Palmitate, Isopropyl Myristate, Lemon Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sodium Acrylate/Sodium Acryldimethyl Taurate Copolymer, Tocopheryl Acetate, Water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43689-0025DB ANTIFUNGAL FOOT (MICONAZOLE NITRATE) CREAM [THE MAGNI GROUP INC]5Legacy NDC20231025_e206738e-6b24-4b03-a84f-7c2521d022ea.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43689-002543689-0025-1, 43689-0025-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CETETH-20I835H2IHHXIACT
CETYL ALCOHOL936JST6JCNIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
EUCALYPTUS OIL2R04ONI662IACT
GARCINIA INDICA SEED BUTTERUS2H3D7800IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LEMON OILI9GRO824LLIACT
TEA TREE OILVIF565UC2GIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALMOND OIL66YXD4DKO9IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
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
3f00accb-cdc5-85ab-e063-6394a90a7e90e206738e-6b24-4b03-a84f-7c2521d022ea2025-09-17WarningsExact identifier
spl set id: e206738e-6b24-4b03-a84f-7c2521d022ea

Reported adverse events (FAERS/openFDA)#

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