Medication info

Bialbetasin Cream

OTC medicationApproval withdrawn
Ingredient · strength
Betamethasone Valerate›Strength being verifiedGentamicin Sulfate›Strength being verified
Manufacturer / importer
(주)보령
Appearance
A white, homogeneous cream formulation
Packaging
30 grams/tube
Approval status
Approval withdrawn

MFDS item code 201602961 · Notified 2016.05.26

This product's status changed to Approval withdrawn on 2023.08.11. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of allergic and inflammatory skin diseases (eczema, contact dermatitis, etc.) and first-degree burns
Who uses it
Adults
Adult dosage
Apply an appropriate amount to the affected area 1 to 3 times a day.

Ingredients

Manufacturer
(주)보령

Efficacy & effects

Treatment of allergic and inflammatory skin diseases (eczema, contact dermatitis, etc.) and first-degree burns

  • Secondary infected allergic skin diseases
  • inflammatory skin diseases
  • eczema
  • contact dermatitis
  • seborrheic dermatitis
  • atopic dermatitis
  • photodermatitis
  • chronic simple eczema
  • scratch dermatitis
  • exfoliative dermatitis
  • itching
  • psoriasis
View approved original text

This medication is effective for various allergic and inflammatory skin conditions including eczema, contact dermatitis, seborrheic dermatitis, atopic dermatitis, and associated symptoms of itching. It is also used for skin injuries such as psoriasis and first-degree burns. It helps improve skin inflammation and secondary infections, thereby facilitating a quicker recovery of the patient’s skin condition.

Dosage and Administration

Adult dosage

Apply an appropriate amount to the affected area 1 to 3 times a day.

Precautions

This medication should not be used if there is a skin infection caused by bacteria, fungi, viruses, or animals as it may worsen the symptoms. Additionally, those who have had an allergic reaction to this medication or its ingredients should avoid using it. Patients with perforated eardrums or severe burns or ulcers should also refrain from using this medication. It is also inappropriate for those with perioral dermatitis or certain skin conditions. Patients allergic to aminoglycoside antibiotics should definitely consult a specialist before using this medication. It is important for pregnant or breastfeeding women, as well as children, to consult a specialist before use. This medication contains an ingredient called propylene glycol, which requires caution from people allergic to it. If unusual reactions such as symptoms of skin infection, irritation, rash, itching, or redness occur during use, use should be stopped immediately and consultation with a specialist is advised. Long-term use or application over large areas may cause thinning of the skin, pigmentation changes, or side effects similar to acne, so care should be taken. Caution is required when applying around the eyes due to the risk of increased intraocular pressure or glaucoma. Long-term use of this medication may lead to issues with kidney function or hearing, therefore prolonged use is not recommended. Dosage and administration should be strictly followed, especially in children, it should be used under parental supervision. Even when used topically, some ingredients may be absorbed systemically and affect hormonal functions, which may require regular checks. Use should be stopped as soon as symptoms improve and prolonged use or occlusive dressings should be avoided. If allergic reactions or skin hypersensitivity symptoms appear, use must be stopped immediately. Regular observation of kidney function or hearing may be necessary while using this medication. Women who may become pregnant or are pregnant should avoid the large or prolonged use of this medication and consult a specialist if treatment is absolutely necessary. Caution is also needed during breastfeeding, and consideration should be given to stopping breastfeeding or the medication if necessary. Children have a larger skin surface area compared to their weight, which makes them more susceptible to side effects, so only minimal amounts should be used. If the skin is sealed due to items like diapers, the absorption of the medication may increase, hence caution is required. Overuse or prolonged use may lead to hormonal dysfunction or side effects such as Cushing's syndrome, thus managing dosage and duration strictly is essential. Patients with psoriasis should be cautious as prolonged or large use may worsen skin symptoms during or after treatment. If blurred vision or visual disturbances occur, consult an ophthalmologist, and this medication should not be used for ophthalmic purposes. Avoid using it after makeup or shaving, and do not use occlusive dressings without medical supervision. Store out of reach of children and keep tightly closed in the original container.

Side effects and when to seek care immediately

Serious side effects

Severe allergic reactions (hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor), severe adverse skin reactions (severe rash with fever, blisters, skin peeling, pain in the mouth/eyes), respiratory problems (shortness of breath or difficulty breathing, asthmatic attacks, abnormal breathing accompanying coughing and fever), liver disorders (jaundice of skin or eyes, general malaise), serious neurological symptoms (sudden and severe headache,

Mild side effects

  • Skin irritation
  • itching
  • rash
  • redness
  • flushing
  • skin dryness
  • pustular dermatitis
  • heat rash
  • worsening of wounds
  • pressure sores
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  • hypersensitivity
  • skin discoloration
  • hypertrichosis
  • steroid-induced acne
  • steroid-induced skin changes

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a container that blocks light and air, and it is best to keep it at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness over a longer period.

Appearance and packaging

Appearance

A white, homogeneous cream formulation

Package unit

30 grams/tube

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.