Daiichi Sankyo Healthcare Troughful Direct a

● Features
● Contains the excellent anti-inflammatory ingredient Triamcinolone Acetonide (steroid ingredient).
● Acts directly on the affected area to reduce inflammation, pain, and swelling, healing painful stomatitis.
● A thin patch type medicine that dissolves and disappears without peeling off.

【Designated Class 2 OTC Drug】

●Efficacy/Effects
Stomatitis (Aphthous)

＜Precautions related to Efficacy/Effects＞


●Dosage and Administration
［Age: Usage method］
Adults (15 years and older): Apply 1 patch per affected area, 1 to 2 times a day, attaching the white side to the affected mucous membrane.
Children (5 years and older): Apply 1 patch per affected area, 1 to 2 times a day, attaching the white side to the affected mucous membrane.
Under 5 years old: Do not use.

＜Precautions related to Dosage and Administration＞
(1) Strictly follow the dosage and administration instructions.
(2) This medicine naturally dissolves over time, so do not forcibly peel it off.
(3) Stop using once the pain subsides. (There is no need to peel off the patch in use.)
(4) When used by children, use under the guidance and supervision of a guardian.
(5) Do not use for infants under 5 years old.
(6) When used by children, be careful as they may peel it off with their fingers after application.
(7) This medicine is for oral mucosal application only; do not swallow. Swallowing will not have any effect.
(8) If accidentally swallowed, apply a new patch to the affected area. If symptoms change or you feel uneasy, consult a doctor, dentist, pharmacist, or registered seller.
(9) Incorrect usage may cause the patch not to adhere properly, so read the instructions carefully and use correctly. Some areas may be difficult to apply; if you cannot apply it well, consult a doctor, dentist, pharmacist, or registered seller.
(10) If you forget to use it, apply it as soon as you remember.
(11) If the affected mucous membrane is significantly wet with saliva, adhesion may be poor. Lightly press tissue paper or gauze on the stomatitis area to wipe off saliva before applying.
(12) After attaching the patch to the affected mucous membrane, avoid touching it strongly with the tongue or other parts as it may peel off. If it peels off before dissolving, discard it without swallowing.
(13) How to remove the medicine:
Slowly peel off the aluminum sheet containing the medicine from the opening and take out the patch for use. (Swallowing it accidentally as is may cause unexpected accidents such as piercing the esophageal mucosa.)

●Ingredients/Quantity
Per patch
Triamcinolone Acetonide 0.025mg

〔Additives〕
Povidone, Hydroxypropyl Cellulose, Tannic Acid, Citric Acid, Macrogol, Titanium Dioxide, Red No. 102, Ethyl Cellulose

＜Precautions related to Ingredients/Quantity＞


●Dosage Form
Patch (external - adhesive agent)

●Precautions for Use
■Do not do (Contraindications)
(Failure to comply may worsen current symptoms or increase the likelihood of side effects)
1. Do not use if you fall under the following:
(1) Suspected infectious stomatitis (consult a doctor, dentist, pharmacist, or registered seller)
● White patches that can be easily wiped off with gauze and spread throughout the oral cavity (suspected candidiasis)
● Presence of yellow pus in the affected area (suspected bacterial infection)
● Multiple small blisters the size of rice grains to azuki beans in the oral cavity, or blisters and rash on lips or skin outside the oral mucosa (suspected viral infection)
● Systemic symptoms such as fever, loss of appetite, general fatigue, swollen lymph nodes (suspected viral infection)
(2) Presence of oral infection
(Do not use on areas with oral infections such as periodontitis or gingivitis, as steroid use may worsen infections)
(3) No symptom improvement after 5 days of use
(4) Symptoms worsen after 1-2 days of use
■Consult
1. Consult a doctor, dentist, pharmacist, or registered seller before use if you fall under the following:
(1) Receiving treatment from a doctor or dentist
(2) Pregnant or possibly pregnant
(3) Breastfeeding
(4) Elderly
(5) Have had allergic reactions to medicines
(6) The affected area is extensive (cannot be fully covered by this medicine)
2. If the following symptoms appear after use, they may be side effects. Stop use immediately and consult a doctor, dentist, pharmacist, or registered seller with this document.
［Affected area: Symptoms］
Oral cavity: White patches (suspected candidiasis), yellow pus in the affected area (suspected bacterial infection)
Others: Allergic symptoms (bronchial asthma attack, edema, etc.)
3. If the following symptoms appear after use, stomatitis caused by infection or other diseases is suspected. Stop use and consult a doctor, dentist, pharmacist, or registered seller with this document.
Fever, loss of appetite, general fatigue, swollen lymph nodes, blisters (outside oral cavity), rash/redness, itching, affected area spreading extensively beyond coverage by this medicine, eye pain, blurred vision, vulvar ulcers

●Precautions for Storage and Handling
(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. (May cause misuse or quality changes)
(4) Do not use products past the indicated expiration date.