{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "10% Azelaic Acid Azelaic Acid Cream CENTELLA ASIATICA LEAF METHYLPROPANEDIOL TARAXACUM OFFICINALE LEAF CETYL ALCOHOL 1,2-HEXANEDIOL LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL HYDROXYPROPYL BETADEX BUTYLENE GLYCOL HYDROXYACETOPHENONE CYCLODEXTRINS WATER XANTHAN GUM SQUALANE ALLANTOIN SORBITAN OLIVATE AZELAIC ACID AZELAIC ACID CETEARYL GLUCOSIDE DIPROPYLENE GLYCOL POLICAPRAM CAPRYLYL GLYCOL MADECASSOSIDE CENTELLA ASIATICA STEPHANIA TETRANDRA ROOT O-CYMENE DIMETHICONE 14% Azelaic Acid Azelaic Acid ALLANTOIN TARAXACUM OFFICINALE LEAF 4-HYDROXY-1-NAPHTHALENESULFONIC ACID WATER AZELAIC ACID AZELAIC ACID O-CYMEN-5-OL BUTYLENE GLYCOL POLICAPRAM 1,2-HEXANEDIOL HYDROXYACETOPHENONE CYCLODEXTRIN CAPRYLYL GLYCOL METHYLPROPANEDIOL CETEARYL GLUCOSIDE DIPROPYLENE GLYCOL SQUALANE HYDROXYPROPYL BETADEX DIMETHICONE CETYL ALCOHOL CENTELLA ASIATICA LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL MADECASSOSIDE STEPHANIA TETRANDRA ROOT STEARYL ALCOHOL SORBITAN OLIVATE XANTHAN GUM"
      ],
      "dosage_and_administration": [
        "Directions Cleanse face to remove dirt and impurities. Wash face and gently pat dry. Dispense cream onto hands and apply directly to acne-prone areas. Use twice daily (morning and evening)."
      ],
      "indications_and_usage": [
        "For the treatment of acne."
      ],
      "active_ingredient": [
        "Azelaic Acid 10%"
      ],
      "purpose": [
        "Acne Treatment"
      ],
      "warnings": [
        "For external use only."
      ],
      "do_not_use": [
        "on broken skin; if allergic to any ingredients."
      ],
      "ask_doctor": [
        "Ask a doctor before use if: pregnant or nursing, or have any underlying medical condition."
      ],
      "when_using": [
        "When using this product: avoid contact with eyes. If contact occurs, rinse thoroughly with water."
      ],
      "stop_use": [
        "Stop use and ask a doctor if: significant facial swelling, large areas of red rash, intense itching or burning sensation."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children: if swallowed, get medical help or contact Poison Control Center right away."
      ],
      "other_safety_information": [
        "Store at room temperature (10°C–25°C). Do not expose to temperatures above 45°C. Keep away from light."
      ],
      "inactive_ingredient": [
        "Water, Butylene Glycol, Methylpropandiol, Dimethicone, Cetearyl Glucoside, Dipropylene Glycol, Sorbitan Olivate, Polyacrylate-6, Squalane, Cetyl Alcohol, Hydroxypropyl Cyclodextrin, 1,2-Hexanediol, 4-Hydroxyacetophenone, Hydroxyethylpiperazineethan Sulfate, Allantoin, Cyclodextrin, Caprylyl Glycine, Xanthan Gum, O-Cymene-5-ol, Madecassoside, Centella Asiatica Extract, Lavandula Angustifolia Oil, Centella Asiatica, Saurus Chinensis Leaf/Root Extract, Taraxacum Officinale Leaf Extract, Stephania Tetrandrae Extract."
      ],
      "spl_unclassified_section": [
        "Distributed by: Ariel Biotech Inc 1226 NORTH KING ST.NUM 968 WILMINGTON, DE 19801 USA"
      ],
      "package_label_principal_display_panel": [
        "14Azelaic Acid 10Azelaic Acid"
      ],
      "set_id": "55b03daa-b6d4-9edf-e063-6394a90ac4d1",
      "id": "55b03daa-b6d5-9edf-e063-6394a90ac4d1",
      "effective_time": "20260703",
      "version": "1",
      "openfda": {
        "application_number": [
          "M006"
        ],
        "brand_name": [
          "10% Azelaic Acid",
          "14% Azelaic Acid"
        ],
        "generic_name": [
          "AZELAIC ACID CREAM",
          "AZELAIC ACID"
        ],
        "manufacturer_name": [
          "Guangzhou Ariel Medical Technology Co., Ltd."
        ],
        "product_ndc": [
          "87815-002",
          "87815-003"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "AZELAIC ACID"
        ],
        "rxcui": [
          "2738813",
          "2746493"
        ],
        "spl_id": [
          "55b03daa-b6d5-9edf-e063-6394a90ac4d1"
        ],
        "spl_set_id": [
          "55b03daa-b6d4-9edf-e063-6394a90ac4d1"
        ],
        "package_ndc": [
          "87815-002-01",
          "87815-003-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000008841",
          "N0000009982"
        ],
        "pharm_class_pe": [
          "Decreased Protein Synthesis [PE]",
          "Decreased Sebaceous Gland Activity [PE]"
        ],
        "unii": [
          "F2VW3D43YT"
        ]
      }
    }
  ]
}