Caution: The following texts are translated from the Japanese original. We cannot take responsibility for ambiguity in the translation.
Designated Category 2 OTC medicine
アフタガード AFTA GUARD
Product features
Slightly sweet “ointment-type” stomatitis medication. Highly adhesive to the oral mucosa, protecting the stomatitis well. Triamcinolone acetonide alleviates inflammation of the affected area with its anti-inflammatory action and improves stomatitis.
Indication
Stomatitis aphthosa
Dosage and administration
Apply an appropriate amount to the affected area once to several times a day.
Precautions of Dosage and Administration
(1)Strictly follow the prescribed dosage and administration.
(2)When allowing children to use the medicine, a guardian must be present to watch and tell such them how to use it.
(3)This drug is for use in the oral cavity only. Do not use outside the oral cavity.
(4) Stop using if the pain is relieved
(5) After applying avoid food and drink for a while.
(6) Do not use for denture adhesion or any other purposes besides treatment.
Ingredient and amount
In 100g
Triamcinolone acetonide ： 100mg： Relieves inflammation in the affected area and improves stomatitis.
Precautions
■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.)
1．This product should not be used by the following persons:
(1)Individuals suspected of infectious stomatitis (Consult your doctor, dentist, pharmacist or registered salesperson.)
●Individuals with extensive white patches which can be peeled off by scrubbing with gauze in the mouth (suspected of candidiasis)
●Individuals with yellow pus in the affected lesion (suspected of bacterial infection)
●Individuals with multiple vesicles (around 3 mm – 6 mm) in the mouth, blisters or rashes on the lip other than oral mucosa or skin (suspected of viral infection) .
●Individuals with systemic symptoms including fever, anorexia, general malaise, swollen lymph nodes (suspected of viral infection) .
(2)Individuals with infection in the mouth
(As there is a report that steroids are associated with worsening of infections, do not apply to the place where oral infection such as alveolar pyorrhea or gingivitis exists.)
(3)Individuals whose symptoms do not improve even after using for 5 days.
(4)Individuals whose symptoms worsen after using for one or two days only.
■Consultation
1．The following persons should contact a physician, dentist, pharmacist, or registered salesperson for a consultation before use.
(1)Patients undergoing medical treatment from a physician or dentist.
(2) Patients who have experienced allergic symptoms associated with drugs, etc.
(3)Pregnant women or women suspected of being pregnant.
(4) Nursing women.
(5)Individuals with extensive affected area (The area cannot be covered by this product) .
(6)The elderly
2．If the following symptoms are observed after using this drug, these may be adverse reactions, so immediately discontinue the use, and show this document to your physician, dentist, pharmacist, or registered sales person for a consultation.
Oral cavity: vitiligo (suspected candida infection), yellow pus on the affected area (suspected bacterial infection), abnormal sense of taste, numbness
Other: allergy symptoms (rash/redness, itching, edema, etc.)
3．If the following symptoms are observed after taking this drug, infectious stomatitis or stomatitis caused by other diseases is suspected. So, immediately discontinue the use of this drug, consult your doctor, dentist, pharmacist, or registered salesperson.
Fever, loss of appetite, systemic symptoms, swollen lymph nodes, blisters (other than oral cavity), rash/redness, itching, extensive affected lesion (the area cannot be covered by this product), eye pain, blurred vision and vulvar ulceration.
Additive
Gelled hydrocarbon, carmellose sodium, sodium saccharine, fragrances
Precautions for storage and handling
(1) Store in a cool, low humidity place away from direct sunlight.
(2)Keep out of reach of children.
(3)Do not transfer the medicine to a different container. (It may lead to misuse or alter the quality of the drug. )
(4)Do not use this product past its expiration date.
(5)After use wipe the mouth of the tube and any ointment on the surrounding areas and close the cap tightly. (Ointment adhering to the tube may harden due to moisture)
Other
＜How to use of AFTA_GUARD＞
①Wash your hands well and clean your fingertip.
②Rinse your mouth to clean.
③Press lightly with tissue paper or gauze to wipe moisture and saliva from the affected area.
(Please be aware that the ointment will not adhere well if the affected area is too dry)"
④When opening the tube for the first time, use the pointy end on the reverse side of the cap.
Wipe moisture or saliva from your fingertips using tissue paper or gauze, then take just enough of the medication from the tube to cover the affected area."
⑤Look in the mirror and apply ointment around the affected area so as to cover it. After applying, avoid food and drink for a while, and try not to touch with your tongue.
(Applying after a meal or before bedtime is recommended)"
⑥Wipe the mouth of the tube and any ointment on the surrounding areas with tissue paper or gauze, and then close the cap tightly. (Ointment may harden due to moisture)
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.
