MedPath

XIMONTH Bee Venom Wart Remover Patch

Approved
Approval ID

3e6965b6-8f08-db62-e063-6394a90a64c9

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 9, 2025

Manufacturers
FDA

Shantou Ximonth Biotechnology Co., Ltd.

DUNS: 457811606

Products 1

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

GLYCERIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84989-010
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
GLYCERIN
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 9, 2025
FDA Product Classification

INGREDIENTS (5)

GLYCERINInactive
Quantity: 7.2 mg in 144 mg
Code: PDC6A3C0OX
Classification: IACT
ALLANTOINInactive
Quantity: 0.072 mg in 144 mg
Code: 344S277G0Z
Classification: IACT
APIS MELLIFERA VENOMInactive
Quantity: 0.0288 mg in 144 mg
Code: 76013O881M
Classification: IACT
AQUAInactive
Quantity: 136.6704 mg in 144 mg
Code: 059QF0KO0R
Classification: IACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILActive
Quantity: 0.0288 mg in 144 mg
Code: VIF565UC2G
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/10/2025

1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/10/2025

Easily remove skin tags, painlessly remove skin warts and moles, and quickly restore smooth skin.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/10/2025

MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/10/2025

1. Easily remove skin tags, painlessly remove skin warts and moles, and quickly restore smooth skin.

2. The formula is mild and suitable for all types of skin, making it safer to use.

3. Using tea tree oil and safflower plant ingredients, it can protect and care for the skin.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/10/2025

1. Clean skin thoroughly and dry first

2. Tear this product apart and apply it to the wart, ensuring that the wart is completely covered

3. Wait a few hours, gently remove the patch, and clean the affected area.

WARNINGS SECTION

LOINC: 34071-1Updated: 9/10/2025

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/10/2025

Discontinue use if signs of irritation or rash occur.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/10/2025

Discontinue use if signs of irritation or rash occur.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/10/2025

Please keep out of reach of children. Do not swallow.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/10/2025

Store in a cool and dry place.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/10/2025

AQUA、GLYCERIN、ALLANTOIN、APIS MELLIFERA VENOM

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/10/2025

1. Clean skin thoroughly and dry first

2. Tear this product apart and apply it to the wart, ensuring that the wart is completely covered

3. Wait a few hours, gently remove the patch, and clean the affected area.

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XIMONTH Bee Venom Wart Remover Patch - FDA Drug Approval Details