Sante Medical 12 12 mL [Class 2 OTC Drug]

Product Information

It is said that we obtain much of our information through our eyes. In today's society, with advanced information technology, there are more and more environments in which we overuse our eyes. In such environments, the eyes' focus adjustment function declines, and eye fatigue (asthenopia) that makes the back of the eyes feel heavy is more likely to occur.
Sante Medical 12 contains a well-balanced combination of 12 carefully selected active ingredients, including 4 ingredients at the maximum concentration*, centered on vitamin B12 and neostigmine methylsulfate, which are effective in relieving eye fatigue. It is an eye drop for relieving eye fatigue that acts on the focus-adjusting muscles and the parasympathetic nerves to enhance the weakened focus adjustment function, moisturizes dry eyes, and also supplies nutrients to the eyes to promote tissue metabolism. It supports the "healthy eyes" lifestyle of everyone living in today's society, where the eyes are overused.
*Maximum concentration under the Approval Standards for Manufacturing and Marketing of OTC Ophthalmic Drugs: vitamin B12, neostigmine methylsulfate, sodium chondroitin sulfate, chlorpheniramine maleate Deviating from the specified dosage and administration of a medicine can lead to serious harm to health. Always read the product instructions carefully before use and follow the dosage and administration. Even when a medicine is used correctly according to the dosage and administration, side effects may occur. If you notice anything unusual, stop use immediately and consult a doctor or pharmacist.

About the Sale of Medicines

●Precautions for Use
■■Things You Must Not Do■■

■■Things To Consult On■■
1. The following persons should consult a doctor, pharmacist, or registered salesclerk before use.
(1) Persons receiving treatment from a doctor
(2) Persons who have had allergic symptoms caused by medicines, etc.
(3) Persons with the following symptom
Severe eye pain
(4) Persons who have received the following diagnosis: glaucoma
2. If any of the following symptoms appear after use, they may be side effects. Stop using it immediately and consult a doctor, pharmacist, or registered salesclerk, bringing this document with you.
[Relevant Area] [Symptoms] Skin: Rash/redness, itching; Eyes: Redness, itching, swelling, stinging pain

3. In the following cases, stop using it and consult a doctor, pharmacist, or registered salesclerk, bringing this document with you.
(1) If blurred vision does not improve
(2) If symptoms do not improve after using it for 5 to 6 days


●Indications
Eye fatigue, conjunctival hyperemia (red eyes), blurred vision (when there is a lot of eye discharge, etc.), itchy eyes, prevention of eye diseases (after swimming, when dust or sweat gets in the eyes, etc.), blepharitis (sore eyelids), eye inflammation caused by ultraviolet rays or other light (snow blindness, etc.), discomfort while wearing hard contact lenses


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

<Please observe the following precautions.>
(1) Excessive use may cause unusual glare sensitivity or may actually lead to redness.
(2) When having a child use this medicine, do so under the guidance and supervision of a parent or guardian.
(3) Do not let the tip of the container touch the eyes, eyelids, or eyelashes (the solution may become contaminated or cloudy due to eye discharge, germs, etc. getting in). Also, do not use the solution if it has become cloudy.
(4) Do not use while wearing soft contact lenses.
(5) For use as eye drops only.


●Ingredients and Amounts
[Ingredient] Vitamin B12 (cyanocobalamin)
[Amount] 0.02%
[Action] Activates the ciliary muscle and relieves eye fatigue.

[Ingredient] Neostigmine methylsulfate [Amount] 0.005% [Action] Relieves eye fatigue, etc. by improving the focus adjustment function.

[Ingredient] Sodium chondroitin sulfate [Amount] 0.5%
[Action] Protects the cornea and moisturizes the eyes by preventing tear evaporation.

[Ingredient] Vitamin B6 (pyridoxine hydrochloride)
[Amount] 0.05%
[Action] Activates tissue metabolism in the eyes.

[Ingredient] Panthenol [Amount] 0.05%
[Action] Activates tissue metabolism in the eyes.

[Ingredient] Potassium L-aspartate [Amount] 0.5%
[Action] Enhances tissue respiration in the eyes.

[Ingredient] Taurine
[Amount] 0.5%
[Action] Activates tissue metabolism in the eyes.

[Ingredient] Chlorpheniramine maleate [Amount] 0.03%
[Action] Suppresses the action of histamine, relieving eye inflammation and itchy eyes.

[Ingredient] Epsilon-aminocaproic acid [Amount] 1.0%
[Action] Suppresses the production of substances that cause inflammation.

[Ingredient] Dipotassium glycyrrhizinate [Amount] 0.1%
[Action] Reduces eye inflammation.

[Ingredient] Zinc sulfate hydrate [Amount] 0.05%
[Action] Reduces eye inflammation through its astringent action.

[Ingredient] Tetrahydrozoline hydrochloride [Amount] 0.03%
[Action] Reduces redness of the conjunctiva (the white of the eye).

Contains the following additives: sodium edetate hydrate, chlorobutanol, sodium hyaluronate, benzalkonium chloride, boric acid, d-borneol, l-menthol, isotonic agent, pH adjuster.

<Precautions related to ingredients and amounts> After instilling this medicine, you may sometimes notice a sweet taste in your mouth. This is because dipotassium glycyrrhizinate, one of the ingredients, flows into the mouth through the tear duct, and it is not due to any abnormality in quality, etc.


●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 a heater. Do not use a product that has been left in a hot place, as the container may have deformed and leaked or the quality of the solution may have deteriorated.
(2) Store out of the reach of children.
(3) Do not transfer to another container.
(This may cause misuse or change the quality.)
(4) Do not share with other people.
(5) Do not use the product after the expiration date. Even before the expiration date, use it as soon as possible after opening.
(6) Depending on storage conditions, crystals of the ingredients may form as a red deposit around the dropper tip of the container or inside the cap. In that case, gently wipe it off with clean gauze before use.
(7) The red color of this medicine is the color of vitamin B12 (cyanocobalamin). If the solution spills during instillation and stains a shirt, etc., wash it with water immediately.


●Contact Information
For inquiries about the contents of this product, please contact the store where you purchased it or the following.
Santen Pharmaceutical Co., Ltd. "Customer Consultation Office"
大阪市北区大深町4-20
Phone 0120-127-023
Hours: 9:00 to 17:00 (excluding Saturdays, Sundays, and public holidays)