FDA.reportPublic FDA data

Tobcharm

Manufacturer
EUbizrival LLC | Guangzhou Pallas Cosmetics Co.,Ltd.
Effective date
2023-09-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:56:07

Label at a glance#

ProductTobcharm
Active ingredientUNDECYLENIC ACID
Label structure9 sections

Indications and uses

Hinder fungal and bacterial growth, reduce itching, cleanse skin tissue.

Dosage and administration

Wash feet thoroughly with warm water, and gently file thickened part of the fungal nail with a nail file until its flat apply layer of the liquid to the surface of the fungal nail and allow it to be absorbed into the nail.  after the liquid has been absorbed, apply a layer of the cream to the infected parts of the nail  repeat the process if necessary once a day  

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 10%

Purpose

OTC - PURPOSE SECTION

Anti-Fungal

Uses

INDICATIONS & USAGE SECTION

Hinder fungal and bacterial growth, reduce itching, cleanse skin tissue.

Warnings

WARNINGS SECTION

For external use only

Do not use

  • on irritated skin and any area that is infected or reddened 
  • if pregnant or if there is any allergic reaction to this product.

When using this product

  • avoid contact with eyes.

Stop use and ask a doctor if

  • if discomfort persists

Keep out of reach of children.

  • if product get into eyes, flush with water for 15 minutes 
  • if swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wash feet thoroughly with warm water, and gently file thickened part of the fungal nail with a nail file until its flat
  • apply layer of the liquid to the surface of the fungal nail and allow it to be absorbed into the nail. 
  • after the liquid has been absorbed, apply a layer of the cream to the infected parts of the nail 
  • repeat the process if necessary once a day  

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature and our of direact sunlight. Skin discoloration may occur during or after use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

mineral oil, apricot kernel oil, tea tree oil, tocopherol, peppermint oil, camphor oil, jojoba oil, bergamot oil, lavender oil

SPL UNCLASSIFIED SECTION

Questions ? Email at

service@Tobcharm.com

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1251008undecylenic acid 10 % Topical SolutionPSN1
1251008undecylenic acid 100 MG/ML Topical SolutionSCD1
1251008undecylenic acid 10 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83462-002-012025-01-30C16284748780-11030e365-0514-111a-e063-dadaa90a10e2d346b98a-2039-4f84-b565-21105962863e
83462-002-012024-01-30C16284748780-11030e365-0514-111a-e063-dadaa90a10e2d346b98a-2039-4f84-b565-21105962863e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83462-002-01Tobcharm30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83462-002TOBCHARM (UNDECYLENIC ACID) LIQUID [EUBIZRIVAL LLC]11 package rows20230907_d346b98a-2039-4f84-b565-21105962863e.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83462-00283462-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPIACT
APRICOT KERNEL OIL54JB35T06AIACT
TEA TREE OILVIF565UC2GIACT
TOCOPHEROLR0ZB2556P8IACT
PEPPERMINT OILAV092KU4JHIACT
CAMPHOR OIL75IZZ8Y727IACT
JOJOBA OIL724GKU717MIACT
BERGAMOT OIL39W1PKE3JIIACT
LAVENDER OILZBP1YXW0H8IACT
UNDECYLENIC ACIDK3D86KJ24NACTIB

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
04b6fb32-4f58-b262-e063-6394a90a5855d346b98a-2039-4f84-b565-21105962863e2023-09-06WarningsExact identifier
spl id: 04b6fb32-4f58-b262-e063-6394a90a5855
spl set id: d346b98a-2039-4f84-b565-21105962863e

Reported adverse events (FAERS/openFDA)#

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