Medication info

Terbinafine Topical Solution 1% (Terbinafine Hydrochloride)

OTC medication
Ingredient · strength
Terbinafine Hydrochloride›1g / 100g
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
Colorless transparent liquid with an ethanol odor
Packaging
30mL/bottle
Approval status
Active

MFDS item code 200404681 · Notified 2004.03.10

Summary

Main use
Treatment of dermatophytes and tinea (fungal infections)
Who uses it
Adults
Adult dosage
Apply once or twice daily according to the indication. Before application, clean the affected area and allow it to dry completely before applying a sufficient amount to immerse the affected area and its surroundings. Treatment period: 1. Tinea pedis, tinea cruris, tinea corporis: once daily for 1 week, 2. Tinea versicolor: twice daily for 1 week.

Ingredients

Manufacturer
주식회사제뉴원사이언스

Efficacy & effects

Treatment of dermatophytes and tinea (fungal infections)

  • Dermatophyte infections
  • tinea pedis
  • tinea cruris
  • tinea corporis
  • tinea versicolor
View approved original text

This medication is used to treat skin fungal infections such as tinea pedis, tinea cruris, and tinea corporis caused by fungi that infect the skin, including Trichophyton, Microsporum, and Epidermophyton. It is also effective for the treatment of tinea versicolor caused by Pityrosporum orbiculare (a type of fungus). Therefore, it is used for the improvement of skin fungal infections and tinea.

Dosage and Administration

Adult dosage

Apply once or twice daily according to the indication. Before application, clean the affected area and allow it to dry completely before applying a sufficient amount to immerse the affected area and its surroundings. Treatment period: 1. Tinea pedis, tinea cruris, tinea corporis: once daily for 1 week, 2. Tinea versicolor: twice daily for 1 week.

Precautions

This medication is an external application made from terbinafine hydrochloride, intended for topical use on the skin. Do not use if you are allergic or hypersensitive to terbinafine or any other ingredients of this medication. It is advisable for women who are pregnant or may become pregnant, as well as breastfeeding women, not to use this medication. Additionally, this medication should not be used in children and infants, as its safety and efficacy have not been sufficiently confirmed. When using this medication, side effects such as hives, redness, erythema, itching, irritation, contact dermatitis, peeling skin, stinging pain, or burning sensation may occur. If these symptoms occur, discontinue use immediately and consult a doctor or pharmacist. If excessive irritation occurs or symptoms worsen while applying the medication, it is important to stop usage and consult a specialist. Do not use occlusive dressings or packaging methods without a doctor's instruction. If there is no improvement despite using this medication, tests should be conducted to precisely assess for fungal infection, and alternative treatments may be applied. This medication contains alcohol, which can cause skin irritation, so precautions are necessary, especially when applied to infants or mucous membranes. Avoid using acidic soap when there is a Candida infection and exercise caution when applying this medication. Care should be taken when applying to wounds or large areas, and when used on infants, as the drug can be absorbed into the body and affect the systemic circulation. Pregnant women should only use this medication carefully if deemed necessary by a physician, as its safety has not been completely established. This medication can be excreted in breast milk, so breastfeeding women are advised to discontinue breastfeeding while using this medication. It is preferable for children not to use this medication as its safety and efficacy have not been fully confirmed. In case of accidental ingestion, appropriate emergency measures such as gastric lavage must be taken immediately. This medication should be used only on the skin and not applied to the eyes or mucous membranes. If it gets into the eyes, rinse immediately with a sufficient amount of water until clean. Avoid using on nails, scalp, around the mouth, or vaginal areas. Exercise caution as it may irritate areas with cracked or wounded skin. This medication must be kept out of reach of children and stored in a safe place. Finally, since there have been instances of mild photosensitivity shown in animal experiments with this medication, caution should be exercised when using it on areas excessively exposed to sunlight.

Side effects and when to seek care immediately

Serious side effects

Skin hives

Mild side effects

  • Redness
  • erythema
  • itching
  • irritation
  • localized contact dermatitis
  • skin peeling
  • stinging pain
  • burning sensation

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, ideally at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain its effectiveness and ensure safe use.

Appearance and packaging

Appearance

Colorless transparent liquid with an ethanol odor

Package unit

30mL/bottle

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.

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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.