43116-048

43116-048
SPL v1
SPL
SPL Set ID 44119185-b692-4123-e063-6394a90acf56
Route
TOPICAL
Published
Effective Date 2025-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyaminopropyl Biguanide (0.1 U) 4-terpineol (0.03 U)
Inactive Ingredients
Water Glycerin Propylene Glycol Panthenol Chamomile Aloe Vera Leaf Ceramide Np Betaine Cocos Nucifera (coconut) Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-21

Description

Polyaminopropyl Biguanide 0.1% 4-Terpineol 0.03%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Polyaminopropyl Biguanide 0.1% 4-Terpineol 0.03%

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

1.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.

2.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

Polyaminopropyl Biguanide 0.1%

4-Terpineol 0.03%

Other Information

● Store below 77°F.(25"C)

● Store in a cool, dry and airy place.

● Validity period for 2 years.

Inactive Ingredients

Water, Glycerin, Propylene Glycol, Panthenol, Chamomilla

Recutita, Aloe Yohjyu Matsu Ekisu, Ceramide Np, Betaine,

Cocos Nucifera (Coconut) Oil



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

1.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.

2.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

Polyaminopropyl Biguanide 0.1%

4-Terpineol 0.03%

Other Information (Other information)

● Store below 77°F.(25"C)

● Store in a cool, dry and airy place.

● Validity period for 2 years.

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Propylene Glycol, Panthenol, Chamomilla

Recutita, Aloe Yohjyu Matsu Ekisu, Ceramide Np, Betaine,

Cocos Nucifera (Coconut) Oil



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)