MedPath

LensMate Preservative-Free Artificial Tears

001-01

Approved
Approval ID

3eda8519-56be-cb15-e063-6394a90a8245

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 15, 2025

Manufacturers
FDA

YD BIO USA, INC.

DUNS: 118330659

Products 1

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

Lubricant Eye Drops

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code87106-001
Application NumberM018
Product Classification
M
Marketing Category
C200263
G
Generic Name
Lubricant Eye Drops
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateSeptember 15, 2025
FDA Product Classification

INGREDIENTS (6)

POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
HYPROMELLOSESActive
Quantity: 0.2 g in 100 g
Code: 3NXW29V3WO
Classification: ACTIB
SODIUM BORATEInactive
Code: 91MBZ8H3QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/15/2025

CartonPrinciple Dislay Panel

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/15/2025

For the temporary relief of burning and irritation due to dryness of the eye
For use as a protectant against further irritation

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/15/2025

Hypromellose 0.2%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/15/2025

Lubricant

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 9/15/2025

Stop use and ask a doctor if you experience any of the following:

Eye pain
Changes in vision
Continued redness or irritation of the eye
Condition worsens or persists for more than 72 hours

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/15/2025

If this solution changes color or becomes cloudy
If you are sensitive to any ingredient in this product

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/15/2025

If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/15/2025

Stop use and ask a doctor if you experience any of the following:

eye pain
Changes in vision
Continued redness or irritation of the eye
Condition worsens or persists for more than 72 hours

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/15/2025

Do not touch tip of container to any surface to avoid contamination
Replace cap after each use
Do not use if bottle seal is broken or missing

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 9/15/2025

Store at room temperature
Use before expiration date marked on container
Retain this carton for future reference

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/15/2025

Sodium chloride, poloxamer, boric acid, sodium borate decahydrate, purified water.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/15/2025

Visit www.yd-biopharma.com

INSTRUCTIONS FOR USE SECTION

LOINC: 59845-8Updated: 9/15/2025

Shake well before using
Instill 1-2 drops in the affected eye(s) as needed

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/15/2025

Directions

Shake well before using
Instill 1-2 drops in the affected eye(s) as needed

WARNINGS SECTION

LOINC: 34071-1Updated: 9/15/2025

For external use only

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LensMate Preservative-Free Artificial Tears - FDA Drug Approval Details