Traful Direct a 24 Patches [Designated Class 2 OTC Drug]

Product Information

Mouth ulcer (stomatitis) treatment
Treats painful, distressing mouth ulcers by applying a patch

Do you have mouth troubles like these?
• It stings, so you cannot enjoy your meals
• It hurts, so talking is difficult
• It bothers you, so you cannot concentrate on work

●Contains triamcinolone acetonide (a steroid ingredient), an anti-inflammatory ingredient with excellent effectiveness.
●Acts directly on the affected area to relieve inflammation, pain, and swelling, and treats distressing mouth ulcers.
●A thin patch-type medicine that dissolves and disappears without needing to be peeled off.

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■■ (Failure to observe these may worsen current symptoms or make side effects more likely)
1. The following persons must not use this medicine.
(1) Persons suspected of having an infectious mouth ulcer (consult a doctor, dentist, pharmacist, or registered salesclerk)
• Persons with white patches spread throughout the oral cavity that can easily be removed by rubbing with gauze, etc. (candida infection is suspected)
• Persons with yellow pus in the affected area (bacterial infection is suspected)
• Persons with many small blisters the size of a grain of rice to an adzuki bean in the oral cavity, or with blisters or rash also on the lips or skin other than the oral mucosa (viral infection is suspected)
• Persons with general symptoms such as fever, loss of appetite, general fatigue, or swelling of the lymph nodes (viral infection is suspected)
(2) Persons with an infection in the oral cavity (because there have been reports of infections worsening with the use of steroid preparations, do not use on sites with oral infections such as pyorrhea or gingivitis)
(3) Persons whose symptoms have not improved after 5 days of use
(4) Persons whose symptoms have worsened after 1 to 2 days of use
■■Things To Consult On■■
1. The following persons should consult a doctor, dentist, pharmacist, or registered salesclerk before use.
(1) Persons receiving treatment from a doctor or dentist
(2) Persons who are pregnant or who think they may be pregnant
(3) Persons who are breastfeeding
(4) Elderly persons
(5) Persons who have had allergic symptoms caused by medicines, etc.
(6) Persons whose affected area is widespread (the affected area cannot be fully covered by this medicine)
2. If any of the following symptoms appear after use, they may be side effects. Stop using it immediately and consult a doctor, dentist, pharmacist, or registered salesclerk, bringing this document with you.

Relevant Area – Symptoms
Oral cavity – White patches (candida infection is suspected), yellow pus in the affected area
(bacterial infection is suspected)
Others – Allergic symptoms (bronchial asthma attacks, edema, etc.)

3. If any of the following symptoms appear after use, a mouth ulcer caused by an infection or by another disease is suspected, so stop using it and consult a doctor, dentist, pharmacist, or registered salesclerk, bringing this document with you.
Fever, loss of appetite, general fatigue, swelling of the lymph nodes, blisters (other than in the oral cavity), rash/redness, itching, the affected area in the oral cavity spreading so widely that it cannot be covered by this medicine, eye pain, blurred vision, genital ulcers



●Indications
Mouth ulcers (aphthous)



●Dosage and Administration
Age – Method of use
Adults (15 years and older) – Apply 1 patch at a time to 1 affected area, 1 to 2 times a day, by attaching the white side to the affected mucosa.

Children (5 years and older) – Apply 1 patch at a time to 1 affected area, 1 to 2 times a day, by attaching the white side to the affected mucosa.

Under 5 years – Do not use.

Method of use
[TRAFUL Direct a is a medicine that treats by being applied.] This medicine is an oral adhesive patch, so do not take it internally (do not swallow it); apply it to the affected area by the method below.
"Mouth ulcers (aphthous)," the target of this medicine, is a general term for inflammation in which one to several small, shallow, painful, whitish round ulcers (less than 10 mm in diameter), reddish around the edges with a shallow depression in the center, form on the inside of the cheeks, the tongue, the inside of the lips, etc.

[Wipe the affected area]
1. Lightly press a tissue or gauze, etc. on the area with the mouth ulcer and wipe away the saliva.
[Take out the patch]
2. Slowly peel open the aluminum sheet from the opening and take out only the medicine (patch).
3. Pick up the medicine (patch) with your fingertips and check the front and back (the pink side and the white side).
Pink (outer side, the side visible from outside)
White (affected-area side, the side to apply)
[Apply and press]
While looking in a mirror, apply it so that it covers the affected area, and press firmly.
4. Lightly press the white side against the affected area, hold it with your fingertip for about 3 seconds while counting 1, 2, 3, and then release your fingertip.
■If it does not stick well, try pressing it for a longer time.
■Apply it by pressing firmly all the way around the edges. If any part is weakly attached, it will peel off more easily.
[Avoid touching it as much as possible]
5. After application, the patch may shift position for a few minutes, so try not to touch it with your tongue.
(It can also be used before going to bed)
■Immediately after application, refrain from eating and drinking and leave it alone as much as possible.
[Dissolves and disappears without peeling off]
6. It dissolves and disappears naturally over time, so do not forcibly peel it off.

<Precautions related to dosage and administration>
(1) Strictly follow the dosage and administration.
(2) This medicine dissolves and disappears naturally over time, so do not forcibly peel it off.
(3) Stop using it when the pain has subsided. (There is no need to peel off a patch that is in use)
(4) When having a child use this medicine, do so under the guidance and supervision of a parent or guardian.
(5) Do not use on infants and young children under 5 years.
(6) When used on children, be careful, as they may peel it off with their fingers after application.
(7) This medicine is an oral adhesive patch, so do not take it internally. Taking it internally has no effect.
(8) If you accidentally swallow it, apply a new patch to the affected area.
If your symptoms change or you have any concerns, consult a doctor, dentist, pharmacist, or registered salesclerk.
(9) This medicine may not stick if used incorrectly, so read the method of use carefully and use it correctly. Depending on the site, some areas may be difficult to apply to, so if you cannot apply it well, consult a doctor, dentist, pharmacist, or registered salesclerk.
(10) If you forget to use it, apply it as soon as possible when you remember.
(11) If the affected mucosa is very wet with saliva, etc., the medicine will not stick well, so first lightly press a tissue or gauze, etc. on the area with the mouth ulcer to wipe away the saliva, and then apply it.
(12) After attaching this medicine to the affected mucosa, it may peel off if you touch it strongly with your tongue, etc., so be careful. If it peels off before dissolving, discard it without swallowing.
(13) How to take out the medicine: Slowly peel open the aluminum sheet containing the medicine from the opening, take it out, and use it. (Accidentally swallowing it as is may lead to unexpected accidents, such as it piercing the esophageal mucosa)



●Ingredients and Amounts
This medicine is a thin, round, film-like patch, and 1 patch contains the following ingredient.
Ingredient – Amount – Action
Triamcinolone acetonide – 0.025 mg
– Acts directly on the affected area to relieve inflammation and improve mouth ulcers.

Additives: povidone, hydroxypropyl cellulose, tannic acid, citric acid, macrogol, titanium oxide, Red No. 102, ethylcellulose



●Precautions for Storage and Handling
(1) Store in a cool place with low humidity, away from direct sunlight.
(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 use the product after the indicated expiration date.

[Other information in the package insert]
"Mouth ulcers (aphthous)" is a general term for inflammation in which one to several small, shallow, painful, whitish round ulcers (less than 10 mm in diameter), reddish around the edges with a shallow depression in the center, form on the inside of the cheeks, the tongue, the inside of the lips, etc.
Unbalanced nutrition, fatigue, lack of sleep, stress, and so on are said to be involved, but the cause is not clear.

Advice for preventing mouth ulcers
○Try to eat nutritionally balanced meals
○Avoid staying up late and irregular lifestyles
○Avoid accumulating stress and fatigue
○Avoid alcohol, tobacco, and irritants as much as possible
○Stimulate saliva secretion with gum, candy, etc. to prevent dryness in the mouth
○Brush your teeth after meals to keep your mouth clean



●Contact Information
For inquiries about this product, please contact the store where you purchased it or the following.
Daiichi Sankyo Healthcare Co., Ltd. Customer Consultation Office
〒103-8234 東京都中央区日本橋3-14-10
Tel. 0120-337-336
Hours: 9:00 to 17:00 (excluding Saturdays, Sundays, and public holidays)

Distributor
Daiichi Sankyo Healthcare Co., Ltd.
東京都中央区日本橋3-14-10

Manufacturer and Distributor
Kyukyu Pharmaceutical Co., Ltd.
富山県射水市戸破32-7