MedPath

Eyelid Wipes

43116-040

Approved
Approval ID

36ddfa37-3913-9e48-e063-6294a90ae1be

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 8, 2025

Manufacturers
FDA

Shenzhen Shierjie Biological Engineering Co., LTD

DUNS: 547610261

Products 1

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

Eyelid Wipes

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43116-040
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Eyelid Wipes
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 8, 2025
FDA Product Classification

INGREDIENTS (13)

CAMELLIA SINENSIS LEAFInactive
Code: W2ZU1RY8B0
Classification: IACT
HYDROXYACETOPHENONEInactive
Code: G1L3HT4CMH
Classification: IACT
CHRYSANTHELLUM INDICUM TOPInactive
Code: STJ856D1Z0
Classification: IACT
4-TERPINEOLActive
Quantity: 0.003 U in 100 U
Code: L65MV77ZG6
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILActive
Quantity: 0.04 U in 100 U
Code: VIF565UC2G
Classification: ACTIB
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POLYAMINOPROPYL BIGUANIDEInactive
Code: DT9D8Z79ET
Classification: IACT
ALOE BARBADENSIS LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
1,2-HEXANEDIOLInactive
Code: TR046Y3K1G
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/6/2025

PRINCIPAL DISPLAY PANEL

1

2

3

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/6/2025

Use

Eyelid Wipes for Dry Eyes and Blepharitis Relief, Stay Hygienic.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/6/2025

Active Ingredient

Melaleuca Alternifolia(Tea Tree)Leaf Oil 0.04%

4-Terpineol 0.003%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/6/2025

Purpose

Antibacterial

WARNINGS SECTION

LOINC: 34071-1Updated: 6/6/2025

Warnings

●For external use only.
●Disposable wipes, one-time use only.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 6/6/2025

Do not use

Do not use if you are allergic to any of the ingredients, not suitable for the eye injuries.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 6/6/2025

When Using

Please remove contact lenses before use. In case of uncomfortable contact, rinse thoroughly with water.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 6/6/2025

Stop Use

Stop use and ask a doctor if irritation or rash appears and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/6/2025

Keep Oot Of Reach Of Children

To avoid the risk of chocking and suffocation, keep wipes and plastic bag away
from babies, children and pets.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/6/2025

Directions

●Wrap the wet wipe around your index finger gently close your eyes and wipe
the eyelid from the base of your lashes outward for 3-5 times.
●Children under 6 years of age should be surpervised when using this product.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 6/6/2025

Other information

●Store below 106°F (41°C)
●Store in a cool, dry and airy place.
●Validity period for 2 years.

INACTIVE INGREDIENT SECTION

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

Inactive ingredients

Water, Propylene Glycol, Sodium Chloride, Hydroxyacetophenone,
1,2-Hexanediol, Butylene Glycol, PolyaminopropyI Biguanide,
Polysorbate 20, Chrysanthellum Indicum Extract,
Aloe Barbadensis Leaf Extract, Camellia Sinensis Extract.

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 6/6/2025

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Eyelid Wipes - FDA Drug Approval Details