FDA.reportPublic FDA data

218 Remedy Antifungal Cream with Zinc Oxide

Manufacturer
Medline Industries, LP
Effective date
2025-11-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:42:30

Label at a glance#

ProductMedline
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) relieves 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 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 four weeks for jock itch, use daily for two wee...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate 2.0% w/w

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)
  • relieves 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 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
  • there is 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 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 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

OTHER SAFETY INFORMATION

  • protect from freezing. Avoid excessive heat.
  • Store at controlled room temperature.

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.

Manufacturing information

SPL UNCLASSIFIED SECTION

www.medline.com ©2024 Medline and Medline Remedy are registered trademarks of Medline Industries, LP.

Made in India.

Manufactured for Medline Industries, LP,
Three Lakes Drive, Northfield, IL 60093 USA.

1-800-MEDLINE

REF: MSC095635

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MICONAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-218-44Medline113 g in 1 TUBECREAM1133

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
53329-21853329-218-44

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CHLOROCRESOL36W53O7109IACT
WHITE PETROLATUMB6E5W8RQJ4IACT
ZINC OXIDESOI2LOH54ZIACT
SODIUM PHOSPHATE DIBASIC DIHYDRATE94255I6E2TIACT
LIGHT MINERAL OILN6K5787QVPIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
EDETATE DISODIUM7FLD91C86KIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956IACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-10-08full-release2026-06-01 00:23:11

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
MedlineMICONAZOLE NITRATEMedline Industries, LP1ea444eb-f2f5-8c63-e063-6294a90acac82025-11-06WarningsExact identifier
ndc (package): 53329-218-44
ndc (product): 53329-218
ndc11 (package): 53329021844
spl id: 42f3af59-a020-421e-e063-6294a90a6eab
spl set id: 1ea444eb-f2f5-8c63-e063-6294a90acac8

Reported adverse events (FAERS/openFDA)#

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