Designated category 2 drug] Flucote f 10 g

Products.

Features of Fullcoat f
It is also effective on areas that are festering and jiggly, and on areas that have been scratched and are accompanied by festering.

☆Fluocinolone acetonide
Synthetic corticosteroids (topical steroids) developed exclusively for topical use and classified as Strong Rank. It has excellent anti-inflammatory properties.
☆Fladiomycin sulphate
Antibiotics effective against many bacteria causing skin infections. Prevents the growth of bacteria in festering affected areas.
*Ointment formulations are less irritating and have a protective effect on the skin, making them suitable for both jiggly and cracked areas.

Usage notes.

■■ What not to do ■■
This product is a skin disease treatment and should not be used for cosmetic or after shaving.
Use with caution, especially on the face, as large quantities or prolonged use may cause acne/pimples on the face and around the mouth, redness and swelling of the facial skin, sharkskin and hypertrichosis of the skin.
Do not use the drug continuously and carelessly after symptoms have improved.

(Failure to comply may worsen current symptoms or increase the likelihood of side effects.)
1. should not be used by the following persons.
(1) People who have experienced allergic reactions to this product.
(2) People who have had allergic reactions to antibiotics or corticosteroids.
2.Do not use on the following areas.
(1) Affected areas with chickenpox (chicken pox), chickenpox and tapeworm.
(2) Wet, badly affected areas with sores.
(3) Eyes, eye area.
3. do not use extensively on the face.
4. do not use for make-up or after shaving.
5. do not use for prolonged periods of continuous use.

■■Consulting ■■.
1.The following persons should consult a doctor, pharmacist or registered pharmacist before use
(1) People under the care of a doctor.
(2) People who have had allergic reactions to medicines or other substances.
(3) People who use it on the face, lips and other mucous membranes.
(4) People with extensive affected areas.
(5) People with deep wounds or severe burns.
(6) Pregnant women or those who appear to be pregnant.
(7) Older people.
2.If any of the following symptoms occur after use, discontinue use immediately and consult a doctor, pharmacist or registered pharmacist with this package insert, as side effects may occur.

[site(s) involved] [condition(s)]
Skin Rash/redness, itching, sores
Skin (affected areas) Tinea, including ringworm and tapeworm, acne, suppurative symptoms, persistent irritation, whitening

If symptoms do not improve after 3.5~6 days of use, discontinue use and consult a doctor, pharmacist or registered pharmacist with this package insert.

Indications/effects.

◎The following conditions with suppuration: eczema, dermatitis, heat rash, rashes, frostbite, insect bites, hives.
◎ Pyogenic skin diseases (ringworm, ringworm and hair folliculitis)

Dosage and administration

Apply an appropriate amount to the affected area once or several times a day.

(1) Adhere strictly to the dosage and administration.
(2) If the product is to be used by children, it should be used under the guidance and supervision of a parent or guardian.
(3) Do not use tight-fitting nappies or plastic or other sealed pants when using in areas where nappies are in contact.
(4) Avoid contact with latex rubber products.
(5) Avoid contact with eyes. In the event of contact with the eyes, wash immediately with water or lukewarm water. If symptoms are severe, seek medical attention from an ophthalmologist.
(6) For external use only.

Ingredients/amounts

Ingredients (in 1 g)
Ingredient Content
Fluocinolone acetonide (synthetic corticosteroid) 0.25 mg
Fladiomycin sulphate (antibiotic) 3.5 mg (potency)

Additives: parabens, polyethylene glycol laurate, propylene glycol, salami beeswax, vaseline.

Storage and handling precautions

(1) Store tightly closed in a cool, dry place out of direct sunlight.
(2) Keep out of reach of children.
(3) Do not replace the product in other containers.
(It can cause misuse and change quality.)
(4) Do not use products past their expiry date.

[Other description.]
Know it right, cure it right.
Skin problems such as eczema and dermatitis cause inflammation in the skin, with redness, swelling and itching as symptoms.
When symptoms of itching are strong, it is unbearable and people scratch, but the scratching irritates the inflammation, which further intensifies itching and leads to a vicious circle of itching.
Scratching the affected area not only prolongs the healing period, but can also leave scars after healing.
Scratched wounds are also prone to bacterial growth and suppuration.
If skin problems are noticed, it is important to treat them well immediately.

Topical steroids (topical synthetic corticosteroid formulations)

■ What are topical steroids?
Adrenocorticosteroids, one of the hormones produced by the body, help to reduce inflammation in the body.
Synthetic corticosteroids are those in which the structure of the corticosteroid has been modified to enhance its anti-inflammatory action. The components used for topical application are called topical steroids, and those formulated for topical use are topical steroids.
As well as reducing symptoms such as redness, swelling and itching, it also acts to reduce inflammation.

■ About strength ranks.
The strength of effect of topical steroids is classified into five levels, including prescription drugs, but there are three levels of OTC drugs on the market: 'Week', 'Mild' and 'Strong'. Fluocinolone acetonide is classified as 'Strong'.

■ Side effects.
Synthetic corticosteroids have been used for many inflammatory diseases as oral agents, but systemic side effects such as suppression of adrenal function have often been a problem. Topical steroids have therefore been developed to reduce systemic effects.
Side effects of topical steroids include thinning of the skin and dilatation of blood vessels in the skin when used continuously over a long period of time. Symptoms may also worsen if used on infected areas such as athlete's foot.
Read the instructions on the back of this product and use it correctly.

Correct use of topical steroids in self-medication.
○Apply an appropriate amount* to the affected area, usually twice a day, or three times a day if symptoms are severe.
○ As symptoms improve, use the product with reduced frequency.
*What is the right amount?
Approximate amount used 'fingertip unit'.

When about the length of the first joint from the tip of an adult index finger (approx. 0.5 g) is taken from the tube, it should be spread over an area of about two adult palms and applied. Use this as a guide to determine the amount to use depending on the size of the affected area.
Do not use for more than □1 week.
□If the condition does not improve or worsens after 5~6 days of use, discontinue use and consult a doctor, pharmacist or registered pharmacist, as the condition may be due to other causes or may be beyond the scope of self-medication.
□If the affected area is wider than 2~3 palms of the person using the product, consult a doctor, pharmacist or registered pharmacist before use, as it may be beyond the scope of self-medication.

Our company has established the Hifunokoto website for eczema, rashes and itching, where you can learn about skin problems and cure them correctly.

http://www.hifunokoto.jp

Contact details.

For enquiries about this product, please contact the shop where you bought it or the following
Mitsubishi Tanabe Pharma 'Pharmaceuticals Consultation Centre'.
3-2-10, Doshomachi, Chuo-ku, Osaka
Toll free 0120-54-7080
9:00~17:30 on our working days
Contact details for the Adverse Effects Relief Scheme.
(Pharmaceuticals and Medical Devices Agency
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Telephone 0120-149-931 (toll-free)
Mitsubishi Tanabe Pharma Corporation