Azelec Cream

• Mild to moderate inflammatory acne vulgaris
• Rosacea

Azelaic acid has been shown to possess antimicrobial activity against Propionibacterium acnes and Staphylococcus epidermidis. The antimicrobial action may be attributable to the inhibition of microbial cellular protein synthesis. A normalization of keratinization leading to an anticomedonal effect of Azelaic acid may also contribute to its clinical activity.

The mechanism of action in the treatment of rosacea is unknown.

Adult:

• Acne vulgaris: 20% cream, apply a thin layer to affected areas twice daily (morning and evening). Improvement may be detectable within 4 weeks. Duration of treatment: up to 6 months.
• Rosacea: Apply to affected areas twice daily (morning and evening). Improvement occurs in 4-8 weeks.

Pediatric (>12 years): Same as adult dose.

Pediatric (<12 years): Safety and efficacy not established.

• Application site burning
• Erythema (redness)
• Itching
• Scaling
• Dryness

In most cases, these reactions are mild and regress as treatment continues.

[SAFE IF PRESCRIBED] Azelaic Acid 20% topical is generally considered safe to use during pregnancy (FDA Pregnancy Category B). Animal studies have shown low or no adverse effects to the developing baby; however, there are limited human studies. Use only if clearly needed.

• Apply only to affected areas
• If severe irritation or allergy occurs, discontinue use and consult your doctor
• For sensitive skin, apply once daily for the first week, then proceed to twice daily
• Avoid contact with eyes; if contact occurs, rinse thoroughly with plenty of water
• Consult your doctor if pregnant or breastfeeding

Over-application may cause skin irritation or allergic reactions. Discontinue use and consult a doctor if symptoms occur.

Store in a cool and dry place, protected from light. Keep out of reach of children.