Azelaic Acid

DRUG INFORMATION

  ADULT
    - Shake well before use. Cleanse affected area(s) using only very mild soaps or
      soapless cleansing lotion and pat dry with a soft towel before application of
      FINACEA Foam. Apply FINACEA Foam twice daily (morning and evening) to the entire
      facial area (cheeks, chin, forehead, and nose). For a single application, dispense
      the smallest amount of foam necessary to adequately cover the affected area(s)
      with a thin layer.
      Source: US FDA label for azelaic acid (FINACEA FOAM), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and efficacy of FINACEA Foam have not been established in pediatric
      patients.
      Source: US FDA label for azelaic acid (FINACEA FOAM), section 'pediatric use',
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - No kidney-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for azelaic acid (FINACEA FOAM),
      retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for azelaic acid (FINACEA FOAM),
      retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Azelaic acid is minimally absorbed systemically following topical
      route of administration, and maternal use is not expected to result in fetal
      exposure to the drug [see Clinical Pharmacology (12.3) ].
      Source: US FDA label for azelaic acid (FINACEA FOAM), section 'pregnancy',
      retrieved 2026-08-29
    - In animal reproduction studies, embryofetal toxicity was noted when azelaic acid
      was administered orally during the period of organogenesis at doses 162, 19, and
      65 times the maximum recommended human dose (MRHD) in rats, rabbits, and monkeys,
      respectively.
      Source: US FDA label for azelaic acid (FINACEA FOAM), section 'pregnancy',
      retrieved 2026-08-29
    - Maternal toxicity was noted at these doses but no malformations were observed in
      these embryofetal developmental studies ( see Data ).
      Source: US FDA label for azelaic acid (FINACEA FOAM), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - No effects on sexual maturation of the fetuses were noted in this study. 8.2
      Lactation Risk Summary Azelaic acid is naturally present in human milk.
      Source: US FDA label for azelaic acid (FINACEA FOAM), section 'use in specific
      populations', retrieved 2026-08-29
    - The developmental and health benefits of breastfeeding should be considered along
      with the mother's clinical need for FINACEA Foam and any potential adverse effects
      on the breastfed child from FINACEA Foam or from the underlying maternal
      condition. 8.4 Pediatric Use The safety and efficacy of FINACEA Foam have not been
      established in pediatric patients.
      Source: US FDA label for azelaic acid (FINACEA FOAM), section 'use in specific
      populations', retrieved 2026-08-29