FDA.reportPublic FDA data

Diabetic Antifungal

Manufacturer
Lavior Inc
Effective date
2021-05-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:40:16

Label at a glance#

ProductDiabetic Antifungal
Active ingredientUNDECYLENIC ACID
Label structure12 sections

Indications and uses

Cures most athlete's foot (tinea pedis) jock itch (tinea cruris) ringworm (tinea corporis) Relieves itching, burning, cracking, and scaling.

Dosage and administration

read all warnings and directions use only as directed wash 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 athletes’ foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily for athle...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 10%...................Antifungal

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

Cures most

  • athlete's foot (tinea pedis)
  • jock itch (tinea cruris)
  • ringworm (tinea corporis)

Relieves itching, burning, cracking, and scaling.

Warnings

WARNINGS SECTION

For external use only. Avoid contact with eyes.

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age unless directed by a doctor

Stop use and consult a doctor if

OTC - STOP USE SECTION

irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or 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

  • read all warnings and directions
  • use only as directed
  • wash 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 athletes’ 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 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
  • wash hands after each use

Other Information

OTC - WHEN USING SECTION

store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Propanediol, Inula Viscosa Flower/Leaf/Stem Extract, Urea, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Arachidyl Alcohol, Zea Mays (Corn) Starch, Behenyl Alcohol, Dimethicone, Pentaerythrityl Tetraethylhexanoate, Synthetic Beeswax, Glycerin, Phenoxyethanol, Euphorbia Cerifera (Candelilla) Wax/Candelilla Cera/Cire de Candelilla, Copernicia Cerifera (Carnauba) Wax/Cera Carnauba/Cire de Carnauba, Arachidyl Glucoside, Glyceryl Stearate SE, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, ButyrospermumParkii (Shea) Butter, Ethylhexylglycerin, Disodium EDTA, Xanthan Gum, Hydroxypropyl Bispalmitamide MEA, Polyglyceryl-2 Stearate, Glyceryl Stearate, Palmitic Acid, Stearyl Alcohol, Pentylene Glycol, Isomerized Safflower Acid, Caprylyl Glycol

Questions?

OTC - QUESTIONS SECTION

Call toll free 1-844-474-2552 or visit www.lavior.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diabetic Antifungal OintmentDiabetic Antifungal Ointment

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71521-391-502023-01-30C16284748780-1f386c64a-1e5e-0266-e053-dadaa90a7c1abdbcf0c0-2cf3-6bd7-e053-2995a90ac3dd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71521-391-50Diabetic Antifungal50 g in 1 BOTTLE, PUMPCREAM504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71521-391DIABETIC ANTIFUNGAL (UNDECYLENIC ACID) CREAM [LAVIOR INC]4Legacy NDC, 1 package rows20210510_bdbcf0c0-2cf3-6bd7-e053-2995a90ac3dd.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71521-39171521-391-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
PROPANEDIOL5965N8W85TIACT
PALMITIC ACID2V16EO95H1IACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
STARCH, CORNO8232NY3SJIACT
PENTAERYTHRITYL TETRAETHYLHEXANOATEXJ7052W897IACT
UREA8W8T17847WIACT
CANDELILLA WAXWL0328HX19IACT
UNDECYLENIC ACIDK3D86KJ24NACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
PENTYLENE GLYCOL50C1307PZGIACT
DOCOSANOL9G1OE216XYIACT
DIMETHICONE92RU3N3Y1OIACT
SYNTHETIC BEESWAX08MNR5YE2RIACT
GLYCERINPDC6A3C0OXIACT
STEARYL ALCOHOL2KR89I4H1YIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
DITTRICHIA VISCOSA WHOLE3SYW69FH88IACT
SHEA BUTTERK49155WL9YIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
TEA TREE OILVIF565UC2GIACT
EDETATE DISODIUM7FLD91C86KIACT
HYDROXYPROPYL BISPALMITAMIDE MONOETHANOLAMIDEEVX7NC9YVEIACT
ISOMERIZED SAFFLOWER ACID70S2158RCIIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARNAUBA WAXR12CBM0EIZIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT

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
c1ed00da-2744-cefc-e053-2a95a90a1ad7bdbcf0c0-2cf3-6bd7-e053-2995a90ac3dd2021-05-09WarningsExact identifier
spl id: c1ed00da-2744-cefc-e053-2a95a90a1ad7
spl set id: bdbcf0c0-2cf3-6bd7-e053-2995a90ac3dd

Reported adverse events (FAERS/openFDA)#

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