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Medline drug information

MICONAZOLE NITRATE
Medline Industries, LP · TOPICAL

Product NDC: 53329-147

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameMICONAZOLE NITRATE
Labeler / manufacturerMedline Industries, LP
RouteTOPICAL
Drug classDrug class not supplied in source label
Product NDC53329-147
Label effective date2026-09-08

Official product label reference

Medline — Medline Industries, LP

This page contains 12 source sections for MICONAZOLE NITRATE, topical route. Label set 0d997d1d-8663-201f-e063-6394a90a285e, version 3.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

Uses for the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris) or ringworm (tinea corporis) relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

Purpose

Purpose Antifungal
Dosage and administration — label text
Directions 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
Warnings
Warnings For external use only Do not use on children under 2 years of age unless directed by doctor When using this product avoid contact with the eyes Stop use and ask a doctor 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. If swallowed, get medical help or contact a Poison Control Center right away.
Active ingredient
Active ingredient Miconazole nitrate 2.0% w/w
Do not use
Do not use on children under 2 years of age unless directed by doctor
While using this medicine
When using this product avoid contact with the eyes
When to stop use and seek help
Stop use and ask a doctor 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
Child safety
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Other information protect from freezing avoid excessive heat
Inactive ingredient
Inactive ingredients acrylamide/ammonium acrylate copolymer, aloe barbadensis leaf juice, apricot kernel oil PEG-6 esters, ascorbic acid, ascorbyl palmitate, cetyl dimethicone, cholecalciferol, citric acid, citrus aurantium dulcis (orange) peel oil, citrus grandis (grapefruit) peel oil, citrus tangerina (tangerine) peel oil, diazolidinyl urea, ethyl vanillin, glycine, glycine soja (soybean) oil, glycol stearate, hydroxytyrosol, l-proline, l-taurine, methylparaben, methylsulfonylmethane, n-acetyl-l-cysteine, niacinamide, olea europaea (olive) fruit oil, olea europaea (olive) leaf extract, PEG-6 stearate, PEG-8, PEG-32 stearate, polyisobutene, polysorbate 20, propanediol, propylene glycol, propylparaben, pyridoxine HCL, retinyl palmitate, silica, tocopherol, triethanolamine, vanillin, water, zea mays oil
Unclassified section
Manufacturing Information www.medline.com ©2022 Medline and Medline Remedy are registered trademarks of Medline Industries, LP. Made in USA of foreign and domestic materials Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA 1-800-MEDLINE REF: MSC092604

Official sources and product identifiers

Substances listed: MICONAZOLE NITRATE

RxNorm identifiers: 998483

Package NDC codes

53329-147-44

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.