Acne Vulgaris

Keratolytic Drugs

Onset of action (cream): Within 4 weeks Absorption: Cream: ~3% to 5% penetrates stratum corneum; up to 10% found in epidermis and dermis; 4% systemic. Metabolism: Negligible after topical application; some beta-oxidation to shorter chain dicarboxylic acids. Half-life elimination: Topical: Healthy subjects: 12 hours. Excretion: Urine (primarily as unchanged drug).

Contraindicated for individuals with an allergy to propylene glycol.

The amount of azelaic acid available systemically following topical administration is minimal (<4%); maternal use is not expected to result in fetal exposure.

It is not known if azelaic acid is present in breast milk.

During the initial stages of use, occasional localized skin irritation (such as redness, peeling, itching, or a burning sensation) may occur. However, these symptoms typically subside gradually as the treatment continues.

1. Cleanse Thoroughly: Before use, the skin should be thoroughly cleaned. You may use water or a mild skin cleanser for this purpose. 2. Application: Apply the product twice daily (morning and evening). It should be applied as a "spot treatment" directly onto the affected areas. 3. Treatment Duration: Significant improvement in symptoms is typically observed after about four weeks of regular use. Depending on the actual condition of the symptoms, you may continue use until the area is fully healed. 4. Handling Irritation: If localized skin irritation occurs, reduce the frequency of application to once per day until the irritation subsides. If the irritation persists, discontinue use.

Children ?12 years and Adolescents: Apply a thin film to affected area(s) twice daily, in the morning and evening; may reduce to once daily if persistent skin irritation occurs

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Store at room temperature. Avoid direct sunlight and moisture, and keep out of the reach of children.