FDA.reportPublic FDA data

774 Aloe Vesta Clear Antifungal Ointment

Manufacturer
Medline Industries, LP
Effective date
2024-07-02
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:59:43

Label at a glance#

ProductAloe Vesta
Active ingredientMICONAZOLE NITRATE
Label structure8 sections

Indications and uses

cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) relieves itching, scaling, cracking, burning, redness, soreness, irritation, and discomfort that accompany these conditions for the treatment of most superficial skin infections caused by yeast (Candida albicans) follow a physician's instructions when treating Candida albicans

Dosage and administration

clean the affected area and dry thoroughly apply a thin layer of ointment over affected area twice daily (morning and night) or as directed by a physician supervise children in use of this product for athlete's foot: pay close 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...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazol nitrate 2% w/w

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • relieves itching, scaling, cracking, burning, redness, soreness, irritation, and discomfort that accompany these conditions
  • for the treatment of most superficial skin infections caused by yeast (Candida albicans)
  • follow a physician's instructions when treating Candida albicans

Warnings

WARNINGS SECTION

For external use only.

Do not use on

OTC - DO NOT USE SECTION

children under 2 years of age unless directed by a physician

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes

Stop use and ask doctor if

OTC - STOP USE SECTION

there is no improvement within 2 weeks for jock itch, or 4 weeks for athlete's foot or ringworm

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 of ointment over affected area twice daily (morning and night) or as directed by a physician
  • supervise children in use of this product
  • for athlete's foot: pay close 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

aloe barbadensis leaf extract, bis-diglyceryl polyacyladipate-2, mineral oil, white petrolatum

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured for: Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA of foreign and domestic materials

www.medline.com

1-800-MEDLINE

REF: 325105

V1 RE21GSG

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53329-774-142023-08-08C16284748780-10191ceaa-70ac-198a-e063-dbdaa90aec3e774 Aloe Vesta Clear Antifungal Ointment
53329-774-642023-08-08C16284748780-10191ceaa-70ac-198a-e063-dbdaa90aec3e774 Aloe Vesta Clear Antifungal Ointment
53329-774-142023-07-28C16284748780-10191ceaa-70ac-198a-e063-dbdaa90aec3e774 Aloe Vesta Clear Antifungal Ointment
53329-774-642023-07-28C16284748780-10191ceaa-70ac-198a-e063-dbdaa90aec3e774 Aloe Vesta Clear Antifungal Ointment

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-774ALOE VESTA (MICONAZOLE NITRATE) OINTMENT [MEDLINE INDUSTRIES, LP]6Legacy NDC20240704_af5ee8d9-f0f2-2659-e053-2995a90a343a.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-77453329-774-14, 53329-774-64

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICONAZOLE NITRATEVW4H1CYW1KACTIB
ALOE VERA LEAFZY81Z83H0XIACT
MINERAL OILT5L8T28FGPIACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
WHITE PETROLATUMB6E5W8RQJ4IACT

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
1c481f65-6f87-e7a8-e063-6294a90a8c30af5ee8d9-f0f2-2659-e053-2995a90a343a2024-07-02WarningsExact identifier
spl id: 1c481f65-6f87-e7a8-e063-6294a90a8c30
spl set id: af5ee8d9-f0f2-2659-e053-2995a90a343a

Reported adverse events (FAERS/openFDA)#

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