MedPath

SOUTH MOON Ingrown Toenail Drops

Approved
Approval ID

3f10b998-49c7-f2b0-e063-6294a90ac7bf

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 18, 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 Code84983-014
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
GLYCERIN
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 18, 2025
FDA Product Classification

INGREDIENTS (6)

SODIUM PCAInactive
Quantity: 0.3 mg in 30 mg
Code: 469OTG57A2
Classification: IACT
PANTHENOLInactive
Quantity: 0.45 mg in 30 mg
Code: WV9CM0O67Z
Classification: IACT
AQUAInactive
Quantity: 28.038 mg in 30 mg
Code: 059QF0KO0R
Classification: IACT
THYMUS VULGARIS (THYME) FLOWER/LEAF OILActive
Quantity: 0.006 mg in 30 mg
Code: 2UK410MY6B
Classification: ACTIB
COMMIPHORA MYRRHA RESINActive
Quantity: 0.006 mg in 30 mg
Code: JC71GJ1F3L
Classification: ACTIB
GLYCERINInactive
Quantity: 1.2 mg in 30 mg
Code: PDC6A3C0OX
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/18/2025

1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/18/2025

Drop the toenail onto the affected toe,until the nail can get out of the groove Take out and trim easily.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/18/2025

Drop the toenail onto the affected toe,until the nail can get out of the groove Take out and trim easily.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/18/2025

Store in a cool and dry place.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/18/2025

AQUA、GLYCERIN、PANTHENOL、SODIUM PCA

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/18/2025

COMMIPHORA MYRRHA RESIN、THYMUS VULGARIS (THYME) FLOWER/LEAF OIL

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/18/2025

Drop the toenail onto the affected toe,until the nail can get out of the groove Take out and trim easily.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/18/2025

SOFTENS IN-GROWING TOENAIL
IMPROVE TOENAIL HEALTH
EFFECTIVE AND GENTLE

WARNINGS SECTION

LOINC: 34071-1Updated: 9/18/2025

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: 9/18/2025

Discontinue use if signs of irritation or rash occur.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/18/2025

Discontinue use if signs of irritation or rash occur.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/18/2025

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

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SOUTH MOON Ingrown Toenail Drops - FDA Drug Approval Details