Caution: The following texts are translated from the Japanese original. We cannot take responsibility for ambiguity in the translation.

Designated Category 2 OTC medicine

ベトノバールSクリーム BETNOVAL S CREAM

Product features

●This product is an eczema and dermatitis treatment containing betamethasone valerate, a highly ranked steroid in the OTC drug category.
●This product soothes inflammation and is highly effective in treating itchy and painful eczema and dermatitis.
●This product is a smooth, non-sticky, white base, odorless cream.

Indication

Eczema, dermatitis, heat rash, rash, itching, chilblains, insect bites, hives

Dosage and administration

Apply an appropriate amount to the affected area once or 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) Attention should be paid so that the medicine will not come into contact with eyes. If the medicine comes into contact with eyes, immediately rinse them with water or lukewarm water. If the symptoms are severe, seek an ophthalmologist for medical treatment.
(4) This medicine is for external use only. Do not ingest it.
(5) Do not cover the area where the medicine has been applied with a non-breathable material, such as plastic wrap. Also, when used on areas that are in contact with a diaper, do not use tight-fitting diapers or non-breathable, leak-proof underwear.
(6) Do not use on non-affected areas as a makeup base/primer or after shaving.

Ingredient and amount

In 100g
Betamethasone valerate:0.12g:Soothes inflammation and relieves itching caused by eczema, dermatitis, etc.

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 taken by the following persons.
Those who have experienced allergic symptoms to this medication or any of its ingredients.
2. The medicine should not be used on the following parts.
(1) Varicella (chickenpox), Athlete’s foot/tinea or purulent lesions.
(2) Eyes, around the eyes.
3. Do not use extensively on the face.
4. Do not use this medicine for a long time.
■Consultation
1. The following persons should contact a physician, pharmacist, or registered salesperson for a consultation before use.
(1) Patients undergoing medical treatment from a physician.
(2) Pregnant women or women suspected of being pregnant.
(3) Patients who have experienced allergic symptoms associated with drugs, etc.
(4) Those with extensive lesions.
(5) Persons with severe exudation, soring or cracking.
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, pharmacist, or registered salesperson for a consultation.

  Skin: Rash/redness, itching.
  Skin (the affected lesion): Dermatomycosis such as Athlete’s foot/tinea, acne, purulent symptom, persistent irritation, whitening.
3. When symptoms do not improve even after using this medicine for 5 to 6 days, stop taking this medicine and consult a physician, pharmacist, or registered salesperson, being sure to take this instruction leaflet with you.

Additive

Vaseline, cetanol, liquid paraffin, polyoxyethylene cetyl ether, sodium citrate, citric acid, parabens

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 the product after its expiration date.

Other

●Please use this product appropriately for treatment.
Skin problems such as rash and dermatitis are caused by inflammation of the affected area. Continued itchiness can lead to uncontrollable scratching, which worsens the symptoms and may leave scars. Therefore, it is important to suppress the inflammation quickly and to improve the symptoms as soon as possible. This product is the highest-ranked topical steroid in the OTC drug category and is effective in relieving inflammation and other painful skin problems. On the other hand, if not used properly, this product may worsen current symptoms or increase the risk of side effects. It is important to read the package insert carefully and use it appropriately.
●It is important to treat painful skin problems quickly.
Eczema, dermatitis, heat rash, rash, itching, chilblains, insect bites, hives
●Rank of steroids in this product
Topical steroids are classified into five ranks according to the strength of their effects, and three ranks are available in the OTC drug category: Week, Medium, and Strong. In general, the higher the rank, the more likely side effects are to occur, so use with caution.

Weak, Medium, *Strong, Very strong, Strongest
*This product (active ingredient: betamethasone valerate) is the highest-ranking topical steroid in the OTC drug category.

Long-term continuous use of topical steroids may cause the skin to become thinner and capillaries to become more prominent. In addition, use of topical steroids on athlete's foot or infected areas may worsen these symptoms. Please read “Precautions” carefully and use as directed .
●How to use this product
Apply an appropriate amount to the affected area once or several times a day. If symptoms improve, reduce the frequency of use. If symptoms do not improve after 5-6 days of use, stop use and consult a physician, pharmacist, or registered sales representative with this document.

The amount equivalent to the length from the tip of an index finger to the first joint of that finger (approx. 0.5 g) is the approximate amount that can be applied to an area equivalent to two palms of an adult hand.
Please adjust the amount to suit the size of the affected area.

When using the product for the first time, insert the needle attached to the cap strongly into the mouth of the tube to puncture the tube’s seal.

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.