Flucort f 10 g [Designated Class 2 OTC Drug]

Product Information

Features of Fullcoat f
Effective even on oozing, pus-filled affected areas and on scratched areas accompanied by pus formation.
☆Fluocinolone acetonide: A synthetic corticosteroid (topical steroid) developed exclusively for external use, classified in the Strong rank. It has excellent anti-inflammatory action.
☆Fradiomycin sulfate: An antibiotic effective against many bacteria that cause skin infections. It prevents bacteria from multiplying in pus-filled affected areas.
*Ointments are low in irritation and also protect the skin, so they are suitable for both oozing and dry, flaky affected areas.

About the Sale of Medicines

●Precautions for Use
■■Things You Must Not Do■■ This medicine is for treating skin diseases. Do not use it as a cosmetic or after shaving.
Using it in large amounts or for a long period may cause acne or pimples on the face or around the mouth, redness or swelling of facial skin, sharkskin-like rough skin, or excessive hair growth, so be especially careful when using it on the face.
Also, do not continue using it aimlessly after symptoms have improved.

(Failure to follow these may worsen current symptoms or make side effects more likely to occur)
1. The following persons must not use this medicine.
(1) Persons who have had allergic symptoms caused by this medicine.
(2) Persons who have had allergic symptoms caused by antibiotics or corticosteroids.
2. Do not use on the following areas.
(1) Affected areas with chickenpox (varicella), athlete's foot, ringworm, etc.
(2) Affected areas that are severely oozing or raw.
(3) The eyes or around the eyes.
3. Do not use over a wide area of the face.
4. Do not use as a cosmetic or after shaving.
5. Do not use continuously for a long period.
■■Things To Consult On■■
1. The following persons should consult a doctor, pharmacist, or registered salesclerk before using this medicine.
(1) Persons receiving treatment from a doctor.
(2) Persons who have had allergic symptoms caused by medicines, etc.
(3) Persons who will use it on the face, or on mucous membranes such as the lips.
(4) Persons whose affected area is extensive.
(5) Persons with deep wounds or severe burns.
(6) Persons who are pregnant or who think they may be pregnant.
(7) Elderly persons.
2. If any of the following symptoms appear after using this medicine, they may be side effects. Stop using it immediately and consult a doctor, pharmacist, or registered salesclerk, bringing this package insert with you.

[Relevant Area] [Symptoms] Skin: Rash/redness, itching, raw skin; Skin (affected area): Tinea such as athlete's foot or ringworm, acne, pus formation, persistent irritation, whitening

3. If symptoms do not improve after using this medicine for 5 to 6 days, stop using it and consult a doctor, pharmacist, or registered salesclerk, bringing this package insert with you.


●Indications
◎The following conditions accompanied by pus formation: eczema, dermatitis, heat rash, skin rash, chilblains, insect bites, hives
◎Pyogenic skin diseases (impetigo, furuncles on the face, folliculitis)


●Dosage and Administration
Apply an appropriate amount to the affected area 1 to several times a day.

(1) Strictly follow the dosage and administration.
(2) When having a child use this medicine, do so under the guidance and supervision of a parent or guardian.
(3) When using on areas covered by a diaper, do not use tight-fitting diapers or airtight pants such as those made of vinyl.
(4) Avoid contact with latex rubber products.
(5) Be careful not to get it in your eyes. If it gets in your eyes, rinse immediately with water or lukewarm water.
If symptoms are severe, see an ophthalmologist.
(6) For external use only.


●Ingredients and Amounts
Ingredients (in 1 g)
Ingredient – Amount
Fluocinolone acetonide (synthetic corticosteroid) 0.25 mg; Fradiomycin sulfate (antibiotic) 3.5 mg (potency)

Additives: paraben, polyethylene glycol laurate, propylene glycol, white beeswax, petrolatum


●Precautions for Storage and Handling
(1) Store tightly closed in a cool place with low humidity, away from direct sunlight.
(2) Store out of the reach of children.
(3) Do not transfer to another container.
(This may cause misuse or change the quality.)
(4) Do not use the product after the expiration date.


[Other information]
Know it correctly, treat it correctly.
Skin troubles such as eczema and dermatitis occur when inflammation develops in the skin, producing symptoms such as redness, swelling, and itching. When itching is severe, you may be unable to resist scratching, but scratching acts as a stimulus that further intensifies the inflammation, leading to a vicious cycle of ever-increasing itchiness. If you scratch the affected area raw, not only will the treatment period be prolonged, but scars may remain even after it heals.
Also, scratched wounds are prone to bacterial growth and pus formation.
When you notice a skin problem, it is important to treat it properly right away.

About topical steroids (topical preparations containing synthetic corticosteroids)

■What are topical steroids?
Corticosteroids, one of the hormones produced in the body, work to suppress inflammation occurring within the body. Synthetic corticosteroids are made by modifying the structure of corticosteroids to enhance their anti-inflammatory action. Among them, ingredients used on the skin are called topical steroids, and those formulated for external use on the skin are topical steroid preparations.
They not only suppress symptoms such as redness, swelling, and itching, but also work to suppress the occurrence of inflammation.

■About strength ranks
The strength of topical steroids, including prescription medicines, is classified into 5 levels,
and 3 levels are sold as OTC medicines: Weak, Mild, and Strong. Fluocinolone acetonide is classified as Strong.

■About side effects
Synthetic corticosteroids have been used as oral medicines for many inflammatory diseases, but systemic side effects such as suppression of adrenal function have often been a problem. Topical steroids were therefore developed to reduce effects on the whole body.
Side effects of topical steroids include thinning of the skin and dilation of skin blood vessels with long-term continuous use. Also, using them on areas with an infection such as athlete's foot may worsen symptoms. Read the precautions for use on the back carefully and use this medicine correctly.

How to use topical steroids correctly in self-medication
○Apply an appropriate amount* to the affected area, usually 2 times a day, or about 3 times a day if symptoms are severe.
○As symptoms improve, use it while reducing the number of applications.
*What is an appropriate amount?
Guideline for the amount to use: the "fingertip unit"

The amount squeezed from the tube from the tip of an adult's index finger to the first joint (about 0.5 g) is spread over an area about the size of 2 adult palms. Using this as a guideline, determine the amount to use according to the size of the affected area.
□Do not use for more than 1 week.
□If there is no improvement or the condition worsens after using it for 5 to 6 days, it may be due to another cause or may be beyond the scope of self-medication, so stop using it and consult a doctor, pharmacist, or registered salesclerk.
□If the affected area is extensive, exceeding 2 to 3 palms of the user's hand, it may be beyond the scope of self-medication, so consult a doctor, pharmacist, or registered salesclerk before use.

We have opened the "Hifu no Koto Site" for thinking about eczema, rashes, and itching, to help you know skin troubles correctly and treat them correctly.
http://www.hifunokoto.jp


●Contact Information
For inquiries about this product, please contact the store where you purchased it or the following.
Mitsubishi Tanabe Pharma Corporation "Drug Consultation Center"
大阪市中央区道修町3-2-10
Toll-free 0120-54-7080
9:00 to 17:30 on our business days
Contact for the Relief System for Sufferers from Adverse Drug Reactions: Pharmaceuticals and Medical Devices Agency (PMDA), Phone 0120-149-931 (toll-free)
Mitsubishi Tanabe Pharma Corporation