添付文書

● Features
Contains the maximum concentration of active ingredients effective for severe eye fatigue※
It is said that we obtain much of our information through our eyes. In modern society, where information technology has advanced, environments that overuse the eyes have increased. In such environments, the eye's focusing adjustment function declines, making it easy to experience eye fatigue, a heavy, dull feeling deep in the eyes.
Sante Medical 12 is an eye fatigue improvement eye drop that thoughtfully combines 12 types of active ingredients in a well-balanced manner, including four ingredients such as vitamin B12 and neostigmine methyl sulfate, which are effective for improving eye fatigue, at their maximum concentrations※. It works on the focusing adjustment muscles and the parasympathetic nervous system to enhance the weakened focusing adjustment function, moisturizes dry eyes, and further nourishes the eyes to promote tissue metabolism function. It supports a "healthy and clear" life for those living in modern society who overuse their eyes.
※Maximum concentration according to the standards for approval of general ophthalmic drugs: vitamin B12, neostigmine methyl sulfate, chondroitin sulfate ester sodium, chlorpheniramine maleate

【Class 2 OTC Drug】

● Efficacy/Effects
Eye fatigue, conjunctival hyperemia, blurred vision (such as when there is a lot of eye discharge), eye itching, prevention of eye diseases (such as after swimming, or when dust or sweat gets into the eyes), blepharitis (eyelid inflammation), eye inflammation caused by ultraviolet or other rays (such as snow blindness), discomfort when wearing hard contact lenses

<Precautions related to Efficacy/Effects>


● Dosage and Administration
Instill 1 to 3 drops per dose, 5 to 6 times a day.

<Precautions related to Dosage and Administration>
● Please observe the following precautions.
(1) Excessive use may cause abnormal glare or paradoxically cause hyperemia.
(2) When used for children, use under the guidance and supervision of a guardian.
(3) Do not let the tip of the container touch the eyes, eyelids, or eyelashes (to prevent contamination or turbidity of the solution due to eye discharge or bacteria). Do not use if the solution is cloudy.
(4) Do not use while wearing soft contact lenses.
(5) For ophthalmic use only.

● Ingredients/Quantity
Cyanocobalamin 0.02%
Neostigmine methyl sulfate 0.005%
Chondroitin sulfate ester sodium 0.5%
Pyridoxine hydrochloride 0.05%
Panthenol 0.05%
L-aspartic acid potassium 0.5%
Aminoethyl sulfonic acid (taurine) 0.5%
Chlorpheniramine maleate 0.03%
Epsilon-aminocaproic acid 1%
Dipotassium glycyrrhizinate 0.1%
Zinc sulfate hydrate 0.05%
Tetrahydrozoline hydrochloride 0.03%

〔Additives〕
Edetate disodium hydrate, chlorobutanol, sodium hyaluronate, benzalkonium chloride, boric acid, d-borneol, l-menthol, isotonic agent, pH adjuster

<Precautions related to Ingredients/Quantity>
This product may sometimes cause a sweet taste in the mouth after instillation. This is due to dipotassium glycyrrhizinate, one of the ingredients, flowing through the tear duct into the mouth and is not due to any abnormality in quality.

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

● Precautions for Use
■ Consult
1. Consult a doctor, pharmacist, or registered seller before use if you:
(1) Are receiving medical treatment from a doctor
(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, discontinue use immediately and consult a doctor, pharmacist, or registered seller with this document, as they may be side effects.
[Affected area: Symptoms]
Skin: rash, redness, itching
Eyes: hyperemia, itching, swelling, stinging pain
3. Discontinue use and consult a doctor, pharmacist, or registered seller with this document if:
(1) Blurred vision does not improve
(2) Symptoms do not improve after 5 to 6 days of use

●Precautions for Storage and Handling
(1) Store tightly closed in a cool place away from direct sunlight. To maintain product quality, do not leave it in places that become hot, such as inside a car or near heating appliances. Do not use if the container is deformed or the solution leaks or deteriorates due to being left in a hot place.
(2) Keep out of reach of children.
(3) Do not transfer to other containers.
(This may cause misuse or change the quality.)
(4) Do not share with others.
(5) Do not use products past the expiration date. Even within the expiration date, use as soon as possible after opening.
(6) Depending on storage conditions, crystals of ingredients may appear red around the dropper tip or inside the cap. In such cases, gently wipe with a clean gauze before use.
(7) The red color of this product is due to vitamin B12 (cyanocobalamin). If the solution spills during instillation and stains clothing, wash immediately with water.