添付文書

● Features
● Mighty Eye Tect EX is an eye drop that contains the anti-inflammatory ingredient "Pranoprofen" [Switch OTC ingredient], combined with four additional ingredients: the antihistamine "Chlorpheniramine Maleate," the corneal protective ingredient "Chondroitin Sulfate Ester Sodium," the corneal repair auxiliary ingredient "Taurine," and the metabolism-promoting ingredient "L-Potassium Aspartate."※
● It is effective for symptoms caused by eye inflammation such as "tearing," "foreign body sensation*," "itchy eyes," and "redness."
■ Mechanism of eye inflammation
When external stimuli such as ultraviolet rays, strong wind, or house dust affect the eyes, the inflammatory mediator "prostaglandin" is produced, which may cause inflammation in the eyes. As a result, symptoms such as "tearing," "foreign body sensation*," "itchy eyes," and "redness" appear.
● A refreshing and cool sensation upon application.
※Compared to our conventional products
*A rolling or prickling sensation

【Class 2 OTC Drug】

●Efficacy/Effects
Relief of the following eye symptoms: tearing, foreign body sensation (rolling or prickling sensation), itchy eyes, conjunctival redness, and blurred vision when there is a lot of eye discharge

<Precautions related to Efficacy/Effects>


●Dosage and Administration
Instill 1 to 2 drops per application, 4 times a day.

<Precautions related to Dosage and Administration>
(1) When used by children, use under the guidance and supervision of a guardian.
(2) Do not let the tip of the container touch the eyes, eyelids, or eyelashes (to prevent contamination or clouding of the solution due to eye discharge or other foreign substances). Do not use if the solution is cloudy.
(3) Do not use while wearing contact lenses (remove lenses before instillation).
(4) Use only for eye drops.
(5) Strictly follow the dosage and administration instructions.

●Ingredients/Quantity
Per 1 mL
Pranoprofen 0.5 mg
Chlorpheniramine Maleate 0.3 mg
Chondroitin Sulfate Ester Sodium 5 mg
Aminoethylsulfonic Acid (Taurine) 1 mg
L-Potassium Aspartate 2 mg

〔Additives〕
Boric acid, borax, hypromellose (hydroxypropyl methylcellulose), edetate disodium hydrate, dibutylhydroxytoluene (BHT), benzalkonium chloride, polysorbate 80, l-menthol

<Precautions related to Ingredients/Quantity>


●Dosage Form
Eye drops (external use [ophthalmic and otorhinolaryngologic solution] - liquid)

●Precautions for Use
■Do not do (Contraindications)
(Failure to observe may worsen current symptoms or increase the likelihood of side effects)
Do not use if you fall under any of the following:
(1) Children under 7 years old.
(2) Pregnant women or those suspected of being pregnant.
(3) Nursing mothers.
■Consult
1. Consult a doctor, pharmacist, or registered seller before use if you:
(1) Are receiving medical treatment.
(2) Have had allergic reactions to medicines.
(3) Have any of the following symptoms:
Severe eye pain
(4) Have been diagnosed with:
Glaucoma
2. If any of the following symptoms appear after use, they may be side effects. Stop use immediately and consult a doctor, pharmacist, or registered seller with this document.
[Affected area: Symptoms]
Skin: rash, redness, itching
Eyes: redness, itching, swelling, irritation, foreign body sensation, tearing, eye discharge
Others: difficulty breathing
3. Stop use and consult a doctor, pharmacist, or registered seller with this document if:
(1) Symptoms worsen.
(2) Blurred vision does not improve (possibility of glaucoma, etc.).
(3) Symptoms do not improve after about 3 days of use.
(4) Use exceeds 2 weeks even if symptoms improve.

●Precautions for Storage and Handling
(1) Store tightly closed in a cool place away from direct sunlight. Do not leave in places that may become hot, such as inside a car or near heating appliances.
(2) To prevent quality changes due to light, keep in this box or similar packaging until use begins.
(3) Keep out of reach of children.
(4) Do not transfer to other containers (may cause misuse or quality changes).
(5) Do not put other substances into the container.
(6) Do not share with others.
(7) Do not use after the expiration date. Even within the expiration date, use promptly after opening the inner bag.
(8) Depending on storage conditions, crystals of the ingredients may form around the tip of the container or inside the cap. In such cases, gently wipe with a clean gauze before use.