FDA.reportPublic FDA data

080 INZO Antifungal Cream

Manufacturer
Medline Industries, LP
Effective date
2024-10-08
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 20:53:07

Label at a glance#

ProductSoothe And Cool Treat
Active ingredientMICONAZOLE NITRATE
Label structure9 sections

Indications and uses

For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) For the treatment of superficial skin infections caused by yeast (candida albicans) Relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

Dosage and administration

clean the affected area and dry thoroughly apply a thin layer over affected area twice daily or as directed by a physician supervise use by children 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 four weeks for jock itch, use daily for two weeks if condition pers...

Storage and handling

Protect from freezing. Avoid excessive heat.

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 cruris), ringworm (tinea corporis)
  • For the treatment of superficial skin infections caused by yeast (candida albicans)
  • Relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

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

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if irritation occurs
  • there is no improvement within 4 weeks for athlete's foot and ringworm
  • thereis no improvement within 2 weeks 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area and dry thoroughly
  • apply a thin layer over affected area twice daily or as directed by a physician
  • supervise use by children
  • 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 four weeks
  • for jock itch, use daily for two weeks
  • if condition persists longer, consult a doctor
  • this product is not effective on scalp or nails

Other information

STORAGE AND HANDLING SECTION

  • Protect from freezing. Avoid excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

allantoin, bees wax, cetyl dimethicone, cetyl PEG/PGG-10/1 dimethicone, dimethicone, fragrance, hydrogenated castor oil, imidazolidinyl urea, isopropyl palmitate, petrolatum, polymethoxy bicyclic oxazolidine, sodium chloride, water, zinc oxide

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured for Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA

www.medline.com
1-800-MEDLINE (633-5463)

REF: MSC095635

V1 RH22SAP

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label V1 RH22SAPLabel V1 RH22SAP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-080-57GM - Gram53329-080dd3c27b5-d2dd-4678-b9ef-191b3976fd3712012-07-24
53329-080-58GM - Gram53329-08067d5c4bd-053a-418b-83a8-efdce3b4539b12012-07-24

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-08053329-080-57, 53329-080-58

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
5-HYDROXYMETHYL(METHYLENEOXY)-1-AZA-3,7-DIOXABICYCLO(3,3,0)OCTANE82EKS47IC5IACT
ALLANTOIN344S277G0ZIACT
YELLOW WAX2ZA36H0S2VIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
DIMETHICONE92RU3N3Y1OIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
PETROLATUM4T6H12BN9UIACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
IMIDUREAM629807ATLIACT

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
23fb980d-c0ee-f7ff-e063-6394a90abc222915e550-a446-66b3-e054-00144ff8d46c2024-10-08WarningsExact identifier
spl id: 23fb980d-c0ee-f7ff-e063-6394a90abc22
spl set id: 2915e550-a446-66b3-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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