Category 3 OTC medicines

New Mytear® CL Vitaclear Cool

Relieves tired eyes after intense use

Before using eye drops while wearing soft contact lenses, check the instructions on the box and package insert and only use the eye drops if you can confirm that they may be used with soft contact lenses.

CHARACTERISTICS

  • This medicine can be used while wearing all types of contact lenses (hard, soft) except colored contact lenses.
  • Can be used by persons who do not wear contact lenses.
  • Contains maximum concentrations* of three active ingredients effective for eyestrain.
    Containing vitamin B6 (pyridoxine hydrochloride) that boosts eye tissue metabolism as well as vitamin B12 (cyanocobalamin) and neostigmine methylsulfate that act on the ciliary muscle to improve eye focusing, the medicine helps reduce “eyestrain,” “blurred vision (eye mucus),” “foreign-body feeling by contact lenses,” etc.
  • Cool and refreshing sensation.

*Based on the Standards for Marketing Approval of Over-the-Counter Ophthalmic Medicines

【What are “Standards for Marketing Approval…”?】
The Standards refer to requirements for pharmaceutical products set by the MHLW in order to streamline its new drug approval process.

PRECAUTIONS FOR USE

Who should seek consultation

1. The following persons should consult a physician, pharmacist, or registered salesperson** before using this medicine:

  • Persons under treatment by a physician
  • Persons who have had allergies to medicines or something
  • Persons who have suffered from the following symptom: Severe eye pain
  • Persons diagnosed with the following condition: Glaucoma

2. Stop using this medicine immediately and consult a physician, pharmacist, or registered salesperson if the following symptoms appear after using this medicine because they might be side effects of the medicine. Take this leaflet with you.

Affected area Symptoms
Skin Rashes, redness, itching
Eye Hyperemia, itching, swelling

3. Stop using this medicine immediately and consult a physician, pharmacist, or registered salesperson in the following cases. Take this leaflet with you.

  • If there is no improvement in your blurred vision.
  • If there is no improvement in your symptoms after using this medicine for about 2 weeks.
**Registered salesperson: person who has the license to sell OTC medicines except Category 1.

INDICATIONS

Eyestrain,foreign-body feeling by contact lenses (soft or hard contact lenses), prevention of eye troubles (after swimming, or to wash out sweat or dust etc.), blurred vision (eye mucus)

DOSAGE AND DIRECTIONS

Apply 2 to 3 drops at a time, 5 to 6 times a day.

< Precautions regarding dosage and directions >

    • Children are permitted to use this medicine only under the direction and supervision of a parent or other responsible adult.
    • Do not touch the tip of the bottle to your eye, eyelid, or eye lashes. (If eye mucus or other foreign matter, etc. is mixed in the bottle, the medical solution can be contaminated or clouded.) In addition, do not use a clouded solution.
    • For ophthalmic use only.
    • Please follow the recommended dosage and directions.
    • Do not use this medicine while wearing colored contact lenses.

INGREDIENTS

INGREDIENTS CONTENTS(in 1mL)
Pyridoxine hydrochloride(Vitamin B6) 1mg
Cyanocobalamin(Vitamin B12) 0.2mg
Neostigmine methylsulfate 0.05mg

Inactive ingredients

Sodium chloride, boric acid, sodium borate, sodium citrate hydrate, chlorobutanol, l-menthol, pH control chemicals

PRECAUTIONS FOR STORAGE AND HANDLING

    • Keep the bottle tightly closed and store it in a cool place away from direct sunlight. Do not leave the medicine where the temperature might become high (especially in cars or near heating appliances).
    • Keep out of the reach of children.
    • To prevent improper use or loss of quality, do not transfer the medicine to another container.
    • Do not transfer other things to the bottle.
    • Do not share the medicine with others.
    • Do not use this medicine after the expiration date. Even before the expiration date, use promptly after opening the inner bag, preferably with in 3 months, to ensure product quality. Be sure to follow the “Precautions regarding dosage and directions” and “Precautions for storage and handling” to ensure product quality.
    • Depending on the conditions of storage, ingredients of the medical solution can be crystalized and attached around the tip of the bottle or inside the cap. In such a case, wipe lightly with clean gauze before use.
    • Because this medicine is a red solution, be careful not to allow it to come into contact with clothing. (If the solution does come into contact with clothing, rinse affected area with water immediately.)

PACKAGE 15mL
OTC Products, etc.