MedPath

SOUTH MOON Wart Remover

Approved
Approval ID

3efd2939-e3d3-869d-e063-6294a90a9868

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 17, 2025

Manufacturers
FDA

Shantou South Moon Biotechnology Co., Ltd.

DUNS: 457126192

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 Code84983-013
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
GLYCERIN
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 17, 2025
FDA Product Classification

INGREDIENTS (5)

GLYCERINInactive
Quantity: 0.5 mg in 10 mg
Code: PDC6A3C0OX
Classification: IACT
AQUAInactive
Quantity: 9.486 mg in 10 mg
Code: 059QF0KO0R
Classification: IACT
CENTELLA ASIATICA TRITERPENOIDSActive
Quantity: 0.01 mg in 10 mg
Code: 4YS74Q4G4J
Classification: ACTIB
HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF WATERActive
Quantity: 0.002 mg in 10 mg
Code: 8FP93ED6H2
Classification: ACTIB
ALOE BARBADENSIS LEAFActive
Quantity: 0.002 mg in 10 mg
Code: ZY81Z83H0X
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/17/2025

1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/17/2025

Take an appropriate amount of this product and apply it on the skin where warts grow.

WARNINGS SECTION

LOINC: 34071-1Updated: 9/17/2025

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: 9/17/2025

Discontinue use if signs of irritation or rash occur.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/17/2025

Discontinue use if signs of irritation or rash occur.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/17/2025

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/17/2025

Store in a cool and dry place.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/17/2025

AQUA、GLYCERIN

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/17/2025

1. Clean skin thoroughly and dry first

2. Take an appropriate amount of this product and apply it on the skin where warts grow.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/17/2025

CENTELLA ASIATICA TRITERPENOIDS、HAMAMELIS VIRGINIANA LEAF WATER、ALOE BARBADENSIS LEAF

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/17/2025

1. Clean skin thoroughly and dry first

2. Take an appropriate amount of this product and apply it on the skin where warts grow.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/17/2025

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. Use tea tree oil and saffron plant ingredients to protect and care for the skin.

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