43116-043

43116-043
SPL v1
SPL
SPL Set ID 377fb842-aa78-ab2a-e063-6394a90a69f9
Route
TOPICAL
Published
Effective Date 2025-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Melaleuca Alternifolia (tea Tree) Leaf Oil (0.04 U) 4-terpineol (0.003 U)
Inactive Ingredients
Propylene Glycol 1,2-hexanediol Butylene Glycol Aloe Barbadensis Leaf Water Polysorbate 20 Chrysanthellum Indicum Top Hydroxyacetophenone Camellia Sinensis Leaf Polyaminopropyl Biguanide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-14

Description

Melaleuca Alternifolia(Tea Tree)Leaf Oil 0.04% 4-Terpineol 0.003%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Melaleuca Alternifolia(Tea Tree)Leaf Oil 0.04% 4-Terpineol 0.003%

Use

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

Stop Use

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

Warnings

●For external use only.

●Disposable wipes, one-time use only.

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.

Do Not Use

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

When Using

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

Active Ingredient

Melaleuca Alternifolia(Tea Tree)Leaf Oil 0.04%

4-Terpineol 0.003%

Other Information

●Store below 106°F (41°C)

●Store in a cool, dry and airy place.

●Validity period for 2 years.

Inactive Ingredients

Water, Propylene Glycol, Hydroxyacetophenone, 1,2-Hexanediol,

Butylene Glycol, Polyaminopropyl Biguanide, Polysorbate 20,

Chrysanthellum Indicum Extract, Aloe Barbadensis Leaf Extract,

Camellia Sinensis Extract.



Principal Display Panel

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.


Structured Label Content

Use

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

Purpose

Antibacterial

Stop Use

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

Warnings

●For external use only.

●Disposable wipes, one-time use only.

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.

Do Not Use (Do not use)

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

When Using

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

Active Ingredient

Melaleuca Alternifolia(Tea Tree)Leaf Oil 0.04%

4-Terpineol 0.003%

Other Information (Other information)

●Store below 106°F (41°C)

●Store in a cool, dry and airy place.

●Validity period for 2 years.

Inactive Ingredients (Inactive ingredients)

Water, Propylene Glycol, Hydroxyacetophenone, 1,2-Hexanediol,

Butylene Glycol, Polyaminopropyl Biguanide, Polysorbate 20,

Chrysanthellum Indicum Extract, Aloe Barbadensis Leaf Extract,

Camellia Sinensis Extract.



Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)