Caution: The following texts are translated from the Japanese original. We cannot take responsibility for ambiguity in the translation.

Category 2 OTC medicine

サロメチールジクロクールローション SALOMETHYL DICLO COOL LOTION

Product features

●Anti-inflammatory analgesic lotion containing diclofenac sodium that has excellent transdermal absorbability.
● Can be applied to a wide area.
● Formulated with 3.0% I-menthol for a cooling sensation that alleviates pain.

Indication

Joint pain, shoulder pain associated with stiff shoulders, tendonitis (hand / wrist pain), elbow pain (such as tennis elbow), muscle pain, back pain, bruise, sprain

Dosage and administration

Apply 3 to 4 times a day to affected area. However, do not cover the rubbing area with a material with poor air permeability such as wrap film. Do not use other external preparations including this component together.

Precautions of Dosage and Administration

1.      Strictly adhere to the prescribed usage and dosage.
This drug does not treat illness that causes pain or swelling, but only treats symptoms such as pain or swelling. Use it only when you have symptoms.
Use only for external use, do not take internally.
Do not use more than 50g per week.
Be careful not to get it in your eyes. Should this get in your eyes, wash immediately with cold or lukewarm water. If the symptoms are severe, consult an ophthalmologist.
Do not use other external preparations at the site of use.
Do not cover the area to be used with a material with poor air permeability (wrap film, straightening belt, etc.) and do not seal it.

Ingredient and amount

In 1g
Diclofenac sodium:10mg.:Non-steroidal anti-inflammatory analgesic ingredients soothe pain and swelling.
l-menthol:30mg:Provides a cooling, refreshing sensation to relieve pain.

Precautions

1.   ■ When not to use the product
(If you do not follow these instructions, the current symptoms may worsen or adverse reactions are more likely to occur.)
This product should not be used in the following persons:
Patients who have had an allergic symptom to this drug or its ingredients.
Those who have experienced asthma
Children under 15 years old.
Pregnant women or women suspected of being pregnant.
Do not use on the following areas.
The area around the eye, the mucosa
Areas where the skin is weak (head, face, underarms, etc.).
Eczema, rash, wounds.
Athlete’s foot/tinea or purulent lesions
Do not use any other anti-inflammatory analgesic for external use while using this product
Do not use continuously for more than two weeks.
■ Consultation
The following persons should contact a physician, pharmacist, or registered salesperson for a consultation before use.
Patients undergoing medical treatment from a physician
Patients who have experienced allergic symptoms associated with drugs, etc.
Persons receiving the following drugs. New quinolones
If any of the following symptoms appear after use, stop taking the medicine immediately and consult a doctor, pharmacist, or registered distributor with this document.
Skin: rash / redness, itching, swelling, rash, pain, irritation, heat, rough skin, desquamation (peeling off dandruff, reddish skin), blisters, pigmentation
In rare cases, the following serious symptoms may occur. In that case, please see a doctor immediately.
Shock (anaphylaxis): Immediately after use, itchy skin, hives, blurred voice, sneezing, itching, stuffiness, palpitations, opacity of consciousness, etc. appear.
Contact dermatitis, photosensitivity: Intense skin irritations such as rash / redness, swelling, irritation, blisters / soreness, pigmentation and vitiligo appear on the patch, with rash / redness, itching Symptoms such as may spread to the whole body. Symptoms may appear or worsen in areas exposed to sunlight.
When symptoms do not improve even after taking the medicine 5 to 6 times, stop taking this medicine and consult a physician, pharmacist or registered salesperson, being sure to take this instruction leaflet with you.

Additive

Polyoxyethylene polyoxypropylene cetyl ether, polyoxyethylene cetyl ether, hydroxypropyl cellulose, alcohol, edetate sodium, propylene glycol

Precautions for storage and handling

1.      Store in a cool, low humidity place away from direct sunlight.
Keep away from fire.
Keep out of reach of children.
Do not transfer the medicine to a different container. (It may lead to misuse or alter the quality of the drug. )
Do not throw used containers into fire.
Do not touch eyes or other mucosa with hands that have this product on them.
Be careful not to get this product on metals such as watches, glasses or accessories, synthetic fibers, plastics, painted floors, and furniture, as this may deteriorate their quality.
Do not take use the product after its expiration date. Please use quickly after opening, even when it is within the expiration date.

Disclaimer on Multilingual Product Information

・This product is a pharmaceutical product approved under a Japanese law, the Law for Ensuring the Quality, Efficacy and Safety of Drugs and Medical Devices, with a view to its sale and use in Japan.

・Multilingual product information is a translation of the product labeling written in Japanese and provided for your information only. It does not warrant that its contents and the product itself conforms to laws and regulations in countries other than Japan.

・Multilingual product information is a tentative translation by Our Company, and may be modified or altered without notice.

・Our Company assumes no responsibility for any occurred problem attributable to the contents of the multilingual product information.