ENUEN CREAM

I. Precautions for Use

1. Do not use this medicine if any of the following applies:
   • You have previously had an allergic reaction to any ingredient in this medicine or to other medicines of the same class.
   • You have itchy skin without redness.
   • You have cuts or open wounds.
   • You have any of the following skin conditions, as this medicine may make them worse:
     • Skin infections, such as cold sores, herpes, chickenpox, impetigo, athlete’s foot, or thrush. Corticosteroids do not treat infections caused by bacteria, yeasts, viruses, or fungi.
     • Acne.
     • Rosacea, a facial skin condition that causes unusual redness of the nose, cheeks, chin, forehead, or entire face, with or without small visible blood vessels, papules, or pustules.
     • Parasitic skin infections, such as scabies.
2. Consult a physician before use if any of the following applies:
   • The patient is under 12 years of age.
   • You have an infection involving the deeper layers of the skin.
3. Consult a physician, pharmacist, or other qualified pharmacy professional before use if any of the following applies:
   • You are pregnant, may be pregnant, or are breastfeeding.
   • You intend to apply this medicine to the face.
   • You have blurred vision or any other visual disturbance.
   • You are using any other prescription or non-prescription medicine containing a corticosteroid. These may include eczema creams, asthma inhalers, oral medicines, injections, nasal sprays, eye drops, or nasal drops.
   • You are taking ritonavir, an antiviral medicine, or itraconazole, an antifungal medicine.
4. Other precautions for use:
   • Store this medicine properly to prevent accidental ingestion by children.
   • Protect from direct sunlight.
   • Do not exceed the recommended amount or frequency of use.
   • If the affected area or the surrounding skin is dirty, wash it thoroughly before applying the medicine.
   • Wash your hands thoroughly before and after using this medicine.
   • This medicine is for external use only and must not be taken by mouth. Do not apply it around the eyes or to mucous membranes, such as those of the mouth, nose, vagina, scrotum, or external genital area. Do not apply it to ulcerated, cracked, or severely injured skin.
   • Avoid contact with the eyes, as this medicine may cause cataracts or glaucoma. If the medicine accidentally enters the eyes, rinse them immediately with clean or lukewarm water and promptly seek medical attention from an ophthalmologist.
   • Do not apply this medicine over a large area. The treated area must not exceed the palm-sized area recommended in the dosage and administration instructions.
   • After application, keep the treated area well ventilated and do not cover it, as covering the area may increase the risk of side effects.
   • Do not apply this medicine to areas other than the affected area, and do not use it as a preventive treatment.
   • Do not use this medicine continuously for more than 7 days.
   • Fungal or bacterial skin infections may sometimes be difficult to distinguish from other forms of dermatitis. Incorrect use of corticosteroids may worsen the condition and make subsequent diagnosis and treatment more difficult.
   • Long-term use in children may be more likely to cause Cushing’s syndrome and adrenal dysfunction.
   • Prolonged use of corticosteroids on the face, underarms, or groin may cause localized skin atrophy.
   • Tinea and other skin infections should be treated with appropriate anti-infective medicines. Using a corticosteroid alone may worsen the condition.
   • If your symptoms return within several weeks after stopping this medicine, usually within two weeks, or if your symptoms have improved but the skin becomes red or develops stinging or burning sensations, you may be experiencing a withdrawal reaction. Take this package insert with you and consult a physician, pharmacist, or other qualified pharmacy professional.

II. Side Effects

1. If any of the following side effects occurs after using this medicine, stop using it immediately and consult a physician, pharmacist, or other qualified pharmacy professional. Take this package insert with you:
   • Skin:
     • Itching, burning sensation, redness, abnormal hair growth, pigmentation, skin atrophy or thinning, dry skin, atrophy or thinning of the subcutaneous tissue, dilated capillaries or blood vessels, and stretch marks.
     • Withdrawal syndrome: After this medicine has been used for a period of time, stopping treatment may cause redness, burning or stinging sensations, severe itching, peeling, oozing of pus, or other related adverse reactions. These reactions may spread beyond the area originally treated.
   • Systemic:
     • Cushing’s syndrome, with symptoms such as a rounded “moon” face, weight gain, fatigue, high blood pressure, excessive hair growth, menstrual abnormalities, personality changes, edema, excessive urination, or excessive thirst.
     • Secondary adrenal insufficiency, with symptoms such as fatigue, weakness, nausea, vomiting, loss of appetite, weight loss, low blood pressure, abdominal pain, constipation, or diarrhea.
2. If any of the following symptoms occurs after using this medicine, stop using it immediately and seek medical attention:
   • Any other discomfort not listed above, such as shortness of breath, difficulty breathing, or swelling of the face, lips, tongue, application site, or any other part of the body.
   • Your condition has not improved or has become worse after 7 days of use.