FDA.reportPublic FDA data

Botanimedix OnychoRX Antifungal Nail Gel

Manufacturer
Cosco International, Inc.
Effective date
2020-01-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:04:05

Label at a glance#

ProductBotanimedix OnychoRX Antifungal Nail Gel
Active ingredientUNDECYLENIC ACID
Label structure6 sections

Indications and uses

For the cure of most Tinea Pedis (athlete's foot) and Tinea Corporis (ringworm) For relief of: Itching, Burning, Redness, Irratation, Scaling, Soreness Discomfort which may accompany these conditions

Dosage and administration

Apply twice daily for best results.

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose
Undecylenic Acid 25%........................Anti-fungal

Uses:

OTC - PURPOSE SECTION

For the cure of most Tinea Pedis (athlete's foot) and Tinea Corporis (ringworm)

INDICATIONS & USAGE SECTION

For relief of:

Itching, Burning, Redness, Irratation, Scaling, Soreness
Discomfort which may accompany these conditions

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply twice daily for best results.

Warnings:

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product

  • Do not get into eyes.
OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • Condition worsens.
  • Symptoms last more than 7 days or clear and occur again within a few days.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Alpha Tocopheryl Acetate (Vitamin E), Cannabidiol, Cetostearyl Alchohol, Clove Leaf Oil, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Oil, Glyceryl Monostearate, Hypromellose, Isopropyl Palmitate, Peppermint Oil, Phenoxyethanol, Polysorbate 60, Propolis Wax, Tea Tree Oil, Urea, Water

Distributed by:

SPL UNCLASSIFIED SECTION

BotaniMedix

Atlanta, GA 30067

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabellabellabel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1362039undecylenic acid 25 % Topical GelPSN3
1362039undecylenic acid 0.25 MG/MG Topical GelSCD3
1362039undecylenic acid 25 % Topical GelSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52261-5800-02025-01-30C16284748780-12cef2736-8970-d83d-e063-dadaa90ab31fBotanimedix OnychoRX Antifungal Nail Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52261-5800-0Botanimedix OnychoRX Antifungal Nail Gel1 in 1 CARTONGEL13
52261-5800-1Botanimedix OnychoRX Antifungal Nail Gel0.002 kg in 1 BOTTLE, WITH APPLICATORGEL0.0023

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52261-5800BOTANIMEDIX ONYCHORX ANTIFUNGAL NAIL GEL (UNDECYLENIC ACID) GEL [COSCO INTERNATIONAL, INC.]3Legacy NDC, 2 package rows20200327_16e8a074-905e-41b5-bb46-c7bb3e914f7a.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52261-580052261-5800-1, 52261-5800-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
UNDECYLENIC ACIDK3D86KJ24NACTIB
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
UREA8W8T17847WIACT
PEPPERMINT OILAV092KU4JHIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
PROPOLIS WAX6Y8XYV2NOFIACT
HYPROMELLOSE 2208 (15000 MPA.S)Z78RG6M2N2IACT
WATER059QF0KO0RIACT
TEA TREE OILVIF565UC2GIACT
EUCALYPTUS OIL2R04ONI662IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CANNABIDIOL19GBJ60SN5IACT
CLOVE LEAF OILVCA5491KVFIACT
DIMETHYL SULFOXIDEYOW8V9698HIACT

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
0c4206d2-bb4d-4adc-9546-67081c2f47f916e8a074-905e-41b5-bb46-c7bb3e914f7a2020-01-29WarningsExact identifier
spl id: 0c4206d2-bb4d-4adc-9546-67081c2f47f9
spl set id: 16e8a074-905e-41b5-bb46-c7bb3e914f7a

Reported adverse events (FAERS/openFDA)#

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