MedPath

XIMONTH Bee Honey Eye Drops

Approved
Approval ID

3e69c950-bbbc-5c47-e063-6294a90a070e

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 Code84989-011
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: 2 mg in 50 mg
Code: PDC6A3C0OX
Classification: IACT
AQUAInactive
Quantity: 46.74 mg in 50 mg
Code: 059QF0KO0R
Classification: IACT
SODIUM PCAInactive
Quantity: 0.5 mg in 50 mg
Code: 469OTG57A2
Classification: IACT
PANTHENOLInactive
Quantity: 0.75 mg in 50 mg
Code: WV9CM0O67Z
Classification: IACT
HONEYActive
Quantity: 0.01 mg in 50 mg
Code: Y9H1V576FH
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

1. Effectively relieve eye dryness and fatigue, improve eye comfort, and keep your eyes fresh at all times.

2. Regular use helps maintain the balance of the eye environment, provides auxiliary support for the daily management of early cataracts and myopia, and promotes stable vision.

3. Helps to immediately relieve the troubles in front of your eyes, and pays more attention to

OTC - ACTIVE INGREDIENT SECTION

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

HONEY

OTC - PURPOSE SECTION

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

1. Effectively relieve eye dryness and fatigue, improve eye comfort, and keep your eyes fresh at all times.

2. Regular use helps maintain the balance of the eye environment, provides auxiliary support for the daily management of early cataracts and myopia, and promotes stable vision.

3. Helps to immediately relieve the troubles in front of your eyes, and pays more attention to long-term eye health.

OTC - WHEN USING SECTION

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

1. After cleaning your hands, take a small amount of this product, then raise your head, pull open your lower eyelids, and drop 1-2 drops of care solution into your eyes.

2. Close your eyes lightly and press the corners of your eyes with your fingertips to evenly distribute the liquid.

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、PANTHENOL、SODIUM PCA

DOSAGE & ADMINISTRATION SECTION

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

1. After cleaning your hands, take a small amount of this product, then raise your head, pull open your lower eyelids, and drop 1-2 drops of care solution into your eyes.

2. Close your eyes lightly and press the corners of your eyes with your fingertips to evenly distribute the liquid.

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