Difamilast ointment provides a new therapeutic option for patients with mild to moderate atopic dermatitis.

I. Indications and Target Populations

1. Clear indication scope

(1) This product is indicated for the topical treatment of mild to moderate atopic dermatitis (also known as eczema).

(2) Atopic dermatitis is a common chronic inflammatory skin disease characterized by dry skin, erythema, papules, and intense pruritus.

(3) This product works by inhibiting inflammatory responses and is intended for patients whose disease severity has been confirmed by a physician as meeting the above criteria.

2. Age appropriateness

(1) This product can be used in adults and pediatric patients aged 2 years and older.

(2) For infants and children under 2 years of age, safety and efficacy have not been established; therefore, use is not recommended.

3. Prerequisites and exclusions

(1) A definitive diagnosis by a physician is required before using this product.

(2) For areas with obvious redness, swelling, pus, pain, or other signs of infection, application should be postponed until the infection is controlled and reassessed.

(3) If atopic dermatitis is severe or in an acute flare, combination with other therapeutic measures may be necessary rather than relying on this product alone.

II. Medication Precautions

1. Strict adherence to external use only

(1) This product is for external use on the skin only. It is strictly forbidden for use in the eyes, mouth, or vagina.

(2) If accidental eye contact occurs, rinse immediately with plenty of water and seek medical attention.

(3) When applying, take a thin layer and spread evenly over the affected area, gently massage until fully absorbed, twice daily (morning and evening). Thick application is not necessary.

2. Hand hygiene and avoiding spread

(1) Wash hands before application; after application, wash hands thoroughly with soap and water to prevent inadvertent contact with other areas.

(2) If another person assists with application, that person should also wash hands afterwards.

(3) Avoid covering the treated area with clothing immediately after application; allow a short time for the ointment to be fully absorbed.

3. Avoid infected areas

(1) If the affected skin shows obvious redness, swelling, warmth, pain, or purulent discharge indicating infection, discontinue use on that area and inform the physician.

(2) Continuing application while infection is uncontrolled may mask or worsen the infection.

4. Course adherence and follow-up

(1) Even if symptoms improve, do not stop treatment early or reduce the frequency of use without authorization. Complete the full course as prescribed.

(2) For long-term use, regular follow-up visits are required so that the physician can assess the need for continued therapy.

III. Patient Information and Health Management

1. Information to inform the physician before use

Before using this product, proactively inform the physician of the following: whether you are pregnant or planning to become pregnant, whether you are breastfeeding, whether you have severe liver or kidney problems, and all medications you are currently taking (including prescription drugs, over‑the‑counter drugs, dietary supplements, and herbal medicines).

2. Special reminder for breastfeeding women

(1) If a breastfeeding woman needs to use this product, avoid applying the ointment to the nipple or areola area.

(2) If applied to areas such as the chest, ensure that the infant’s skin does not come into contact with the treated site to minimize infant exposure.