MedPath

Tobcharm Fungus Nail Renewal

85817-005

Approved
Approval ID

4001247d-4704-8786-e063-6394a90a083a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 30, 2025

Manufacturers
FDA

Guangzhou Qiexiran Cosmetics Co., Ltd.

DUNS: 513170495

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Fungus Nail Renewal

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85817-005
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Fungus Nail Renewal
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 30, 2025
FDA Product Classification

INGREDIENTS (10)

JOJOBA OILInactive
Code: 724GKU717M
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
CAMPHOR OILInactive
Code: 75IZZ8Y727
Classification: IACT
BERGAMOT OILInactive
Code: 39W1PKE3JI
Classification: IACT
UNDECYLENIC ACIDActive
Quantity: 25 g in 100 mL
Code: K3D86KJ24N
Classification: ACTIB
APRICOT KERNEL OILInactive
Code: 54JB35T06A
Classification: IACT
TEA TREE OILInactive
Code: VIF565UC2G
Classification: IACT
LAVENDER OILInactive
Code: ZBP1YXW0H8
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/30/2025

PRINCIPAL DISPLAY PANEL

1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/30/2025

Use

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/30/2025

Active Ingredient

Undecylenic Acid 25%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/30/2025

Purpose

Antifungal

WARNINGS SECTION

LOINC: 34071-1Updated: 9/30/2025

Warnings

For external use only.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/30/2025

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.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/30/2025

When Using

Avoid contact with eyes.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/30/2025

Stop Use

Stop use and ask a doctor If discomfort persists.​​

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 9/30/2025

Ask Doctor

If you have diabetes or poor blood circulation.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/30/2025

Keep Out Of Reach Of Children

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/30/2025

Directions

Wash feet thoroughly with warm water, and gently file the thickened part of the fungal nail with a nail file until it's flat.
Apply a layer of the liquid to the surface of the fungal nail and allow it to be absorbed into the nail.
Repeat the process twice a day. Use it continuously for at least 4 weeks to see the effect. And if you want complete improvement, we recommend using it for 6 weeks or more.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/30/2025

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/30/2025

Inactive ingredients

Mineral oil, Apricot Kernel Oil, Tea Tree Oil, Tocopherol, Peppermint Oil, Camphor Oil, Jojoba Oil, Bergamot Oil, Lavender Oil.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/30/2025

Questions

Email at Service@Tobcharm.com​

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Tobcharm Fungus Nail Renewal - FDA Drug Approval Details