Traful Direct a 24 patches (category II drug, special)

**Product Description**
An adhesive patch for treating painful canker sores.

● Contains triamcinolone acetonide, a highly effective anti-inflammatory steroid ingredient.
● It acts directly on the affected area to relieve inflammation, pain, and swelling, and treats painful canker sores.
● This medication is a thin, dissolving film that does not need to be peeled off.

**Precautions for Use**
● **Contraindications**
(Failure to follow these instructions may result in worsening of current symptoms or an increased risk of side effects.)
The following persons should not use this product:
1. Persons with suspected infectious stomatitis (consult a physician, dentist, pharmacist, or registered salesperson).
(1) Persons with white patches that can be easily wiped off with gauze and are spread throughout the oral cavity (suspected Candida infection).
(2) Persons with yellow pus in the affected area (suspected bacterial infection).
(3) Persons with multiple small vesicles in the oral cavity, or with vesicles and rashes on the lips or skin outside the oral mucosa (suspected viral infection).
(4) Persons with systemic symptoms such as fever, loss of appetite, general malaise, or swelling of lymph nodes (suspected viral infection).
2. Persons with an infection in the oral cavity (As there are reports that the use of steroids can worsen infections, do not use on areas with oral infections such as alveolar pyorrhea or gingivitis).
3. Persons whose symptoms do not improve after 5 days of use.
4. Persons whose symptoms worsen after 1-2 days of use.

● **Consultation**
1. The following persons should consult a physician, dentist, pharmacist, or registered salesperson before use:
(1) Persons undergoing treatment by a physician or dentist.
(2) Persons who are pregnant or may be pregnant.
(3) Persons who are breastfeeding.
(4) The elderly.
(5) Persons who have had allergic reactions to medications or other substances.
(6) Persons with a large affected area (too large to be covered by this product).
2. If the following symptoms appear after use, they may be side effects. Discontinue use immediately and consult a physician, dentist, pharmacist, or registered salesperson with this document.
Oral cavity: White patches (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 appear after use, stomatitis due to infection or another disease may be suspected. Discontinue use and consult a physician, dentist, pharmacist, or registered salesperson with this document.
Fever, loss of appetite, general malaise, swelling of lymph nodes, vesicles (outside the oral cavity), rash/redness, itching, the affected area in the oral cavity spreading too wide to be covered by this product, eye pain, blurred vision, vulvar ulcers.

**Indications or Effects**
Stomatitis (aphthous)

**Dosage and Administration**
● Adults (15 years of age and older)
Apply one patch to the affected area once, 1 to 2 times a day, with the white side adhering to the mucous membrane.

● Children (5 years of age and older)
Apply one patch to the affected area once, 1 to 2 times a day, with the white side adhering to the mucous membrane.

● Under 5 years of age
Do not use.
(1) Strictly follow the dosage and administration instructions.
(2) This product will naturally dissolve over time. Do not forcibly peel it off.
(3) Discontinue use once the pain has subsided. (It is not necessary to remove a patch that is already in use).
(4) When used by children, it should be under the guidance and supervision of a guardian.
(5) Do not allow infants and children under 5 years of age to use this product.
(6) When used by children, be aware that they may try to peel it off with their fingers after application.
(7) This product is an oral patch and should not be taken internally. It is not effective if ingested.
(8) If accidentally swallowed, apply a new patch to the affected area. If your symptoms change or you have any concerns, consult a physician, dentist, pharmacist, or registered salesperson.
(9) This product may not adhere properly if the application method is incorrect. Please read the instructions carefully and use it correctly. Some areas may be difficult to apply to; if you cannot apply it properly, consult a physician, dentist, pharmacist, or registered salesperson.
(10) If you miss a dose, apply it as soon as you remember.
(11) If the affected mucous membrane is excessively wet with saliva, the patch will not adhere well. Before applying, gently pat the area of the canker sore with a tissue or gauze to wipe away saliva.
(12) After applying the patch to the mucous membrane, avoid touching it strongly with your tongue, as it may come off. If the patch comes off before it has dissolved, do not swallow it; discard it.
(13) How to remove the medication from the packaging: Slowly peel open the aluminum sheet from the opening, take out the patch, and use it. (Accidentally swallowing the packaging as is can lead to unexpected accidents, such as it getting stuck in the esophageal mucosa).

**Ingredients**
[Per patch]
Triamcinolone Acetonide…0.025mg
Additives: Povidone, Hydroxypropyl Cellulose, Tannic Acid, Citric Acid, Macrogol, Titanium Dioxide, Red No. 102, Ethylcellulose

**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 another container. (This may cause misuse or a change in quality).
(4) Do not use this product after the expiration date indicated.