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Antifungal

Manufacturer
A-S Medication Solutions
Effective date
2018-01-05
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-02 01:01:11

Label at a glance#

ProductAntifungal
Active ingredientMICONAZOLE NITRATE
Label structure12 sections

Indications and uses

cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) for effective relief of itching scaling cracking burning redness soreness irritation discomfort

Dosage and administration

This product is not effective on the scalp or nails. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks. clean 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;...

Storage and handling

To open: unscrew cap, use pointed end on cap to puncture seal store at room temperature see carton or tube crimp for lot number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • for effective relief of
    • itching
    • scaling
    • cracking
    • burning
    • redness
    • soreness
    • irritation
    • discomfort

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before use

OTC - ASK DOCTOR SECTION

  • on children under 2 years of age

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)

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.

Directions

DOSAGE & ADMINISTRATION SECTION

This product is not effective on the scalp or nails.

For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.

  • clean 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; change shoes and socks at least once daily

Other information

STORAGE AND HANDLING SECTION

  • To open: unscrew cap, use pointed end on cap to puncture seal
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

apricot kernel oil, benzoic acid, BHT, glycol stearate, mineral oil, PEG-6, PEG-6-32 stearate, purified water

Questions?

OTC - QUESTIONS SECTION

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by McKesson One Post Street
San Francisco, CA 94104

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-1351

NDC: 50090-1351-0 30 g in a TUBE

Miconazole Nitrate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-689-72GM - Gram49348-689ae015f1f-68b8-4209-b295-89bdbc8d553712013-02-19

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
50090-135150090-1351-0
49348-689

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
MICONAZOLE NITRATEVW4H1CYW1KACTIB
apricot kernel oil54JB35T06AIACT
benzoic acid8SKN0B0MIMIACT
butylated hydroxytoluene1P9D0Z171KIACT
glycol stearate0324G66D0EIACT
mineral oilT5L8T28FGPIACT
polyethylene glycol 3005655G9Y8AQIACT
water059QF0KO0RIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUNMARK MICONAZOLE NITRATE antifungalMICONAZOLE NITRATEStrategic Sourcing Services LLC7c15d95a-5b89-4789-8c91-3f61d7ec77072025-07-30WarningsExact identifier
ndc (product): 49348-689
8183fb0d-a25a-49fe-83ab-70ff1c6cdb286906efce-f67e-412b-8ba0-2cd47b3d823b2020-01-18WarningsExact identifier
spl set id: 6906efce-f67e-412b-8ba0-2cd47b3d823b

Reported adverse events (FAERS/openFDA)#

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