第一三共ヘルスケア トラフルダイレクトa

Features

●Contains triamcinolone acetonide (a steroid component), a highly effective anti-inflammatory ingredient.
●It acts directly on the affected area to relieve inflammation, pain, and swelling, and cure painful mouth ulcers.
●This is a thin film type medicine that dissolves without needing to be peeled off.

[Designated Category 2 OTC drug]

Efficacy and effectiveness

Mouth ulcers (aphthous)

<Notes regarding efficacy and effectiveness>

Dosage and Administration

[Age: How to use]
Adults (15 years of age or older): Apply one sheet to each affected area, 1 to 2 times a day, by attaching the white side to the affected mucosa.
Children (5 years and older): Apply one sheet to each affected area, 1 to 2 times a day, by attaching the white side to the affected mucosa.
Under 5 years old: Do not use.

<Caution regarding usage and dosage>

(1) Please strictly follow the usage and dosage instructions.
(2) This medication will dissolve naturally over time, so do not try to remove it by force.
(3) Stop using the patch once the pain has subsided. (There is no need to remove the patch you are currently using.)
(4) If used by children, please use under the guidance and supervision of a parent or guardian.
(5) Do not allow use by infants under 5 years of age.
(6) When using on children, please be careful as there is a risk that the patch may be removed with your fingers after application.
(7) This medicine is an oral patch, so do not take it orally. It will not be effective if taken orally.
(8) If the medicine is swallowed by mistake, apply a new medicine to the affected area. If your symptoms change or you have any concerns, consult a doctor, dentist, pharmacist, or registered distributor.
(9) This drug may not adhere properly if used incorrectly, so please read the instructions carefully and use it correctly. Depending on the area of ​​application, there are some areas that are difficult to apply, so if you are having trouble applying it, please consult a doctor, dentist, pharmacist, or registered distributor.
(10) If you forget to use the patch, apply it as soon as possible when you remember.
(11) If the affected mucous membrane is excessively wet with saliva, etc., the medication will not adhere well to the mucous membrane. Therefore, lightly apply tissue paper or gauze to the area with the stomatitis and wipe off any saliva before applying the medication.
(12) After applying this medicine to the affected mucous membrane, if you touch it strongly with your tongue, it may come off. Please be careful. If it comes off before it dissolves, discard it without swallowing it.
(13) How to take out the medicine Slowly remove the aluminum sheet containing the medicine from the opening, take it out and use it. (If swallowed by mistake, it may cause an unexpected accident such as piercing the esophageal mucosa.)

Ingredients and quantities

In 1 <br>Triamcinolone acetonide 0.025mg

[Additives]

Povidone, hydroxypropyl cellulose, tannic acid, citric acid, macrogol, titanium oxide, Red No. 102, ethyl cellulose

<Notes regarding ingredients and quantities>

Dosage form

Patch (tablet for external use)

Usage notes

■Things you shouldn't do (If you do not follow these instructions, your current symptoms may worsen or you may be more susceptible to side effects.)
1. Do not use if you are:
(1) People who suspect they have infectious stomatitis (consult with a doctor, dentist, pharmacist, or registered distributor)
Those who have white spots that can be easily removed by rubbing with gauze or other items and have spread throughout their mouths (a candida infection is suspected)
People with yellow pus in the affected area (bacterial infection suspected)
Those who have many small blisters the size of a grain of rice or azuki beans in their mouths, or blisters or rashes on the lips or skin other than the oral mucosa (a viral infection is suspected)
Those who have systemic symptoms such as fever, loss of appetite, general malaise, or swollen lymph nodes (a viral infection is suspected)
(2) People with oral infection (Please do not use on areas with oral infections such as pyorrhea or gingivitis, as there have been reports of infections worsening with the use of steroids.)
(3) People whose symptoms do not improve after 5 days of use (4) People whose symptoms worsen after using the drug for 1 to 2 days ■Things to consult about
1. The following people should consult a doctor, dentist, pharmacist, or registered distributor before use.
(1) People receiving treatment from a doctor or dentist (2) Pregnant women or those suspected to be pregnant
(3) People who are breastfeeding (4) Elderly people (5) People who have experienced allergic symptoms due to medicine, etc. (6) Those with widespread affected areas (those that cannot be completely covered with this drug)
2. If the following symptoms are observed after use, these may be side effects, so discontinue use immediately and consult a doctor, dentist, pharmacist, or registered distributor with this leaflet.
[Affected area: Symptoms]
In the mouth: White spots (suspected Candida infection), yellow pus in the affected area (suspected bacterial infection)
Other: Allergic symptoms (bronchial asthma attacks, edema, etc.)
3. If the following symptoms are observed after use, stomatitis caused by an infectious disease or other illness may be suspected. Discontinue use and consult a doctor, dentist, pharmacist, or registered distributor with this leaflet.
Fever, loss of appetite, general malaise, swollen lymph nodes, blisters (other than in the mouth), rash/redness, itchiness, the affected area in the mouth spreads to a wide area that cannot be completely covered with this medicine, sore eyes, blurred vision, vulvar ulcers

Storage and handling precautions

(1) Store in a cool, dry place away from direct sunlight.
(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 use products after the expiration date indicated.