{
  "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": "2026-06-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Adapalene Gel 0.1% Adapalene Gel 0.1% ADAPALENE ADAPALENE CARBOMER 980 BENZYL ALCOHOL POLOXAMER 124 EDETATE DISODIUM PROPYLENE GLYCOL WATER SODIUM HYDROXIDE"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENT Adapalene (retinoid) 0.1%"
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS Inactive ingredients: Carbopol 980, edetate disodium, benzyl alcohol, Poloxamer 124, Propylene Glycol, Purified Water, Sodium Hydroxide"
      ],
      "purpose": [
        "PURPOSE Acne Treatment"
      ],
      "warnings": [
        "WARNINGS For external use only"
      ],
      "instructions_for_use": [
        "USES For the treatment of acne",
        "DIRECTIONS Adults and children 2 years and older: use once daily clean the skin gently and pat dry before applying the product cover the entire affected area with a thin layer. For example, if your acne is on the face, apply the product to the entire face do not use more than one time a day. Applying more than directed will not provide faster results or better results, but may worsen skin irritation. Children under 12 years of age ask a doctor"
      ],
      "do_not_use": [
        "DO NOT USE on damaged skin (cuts, abrasions, eczema, sunburn) If you are allergic to adapalene or any of the ingredients in this product"
      ],
      "when_using": [
        "WHEN USING THIS PRODUCT limit sun exposure, including light from tanning beds and use sunscreen when going outdoors do not wax to remove hair in areas where the product has been applied during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you irritation that becomes severe irritation (redness, itching, dryness, burning) is more likely to occur in the first few weeks of use if using more more than one topical acne medication at a time but irritation usually lessens with continued use of this product it may take up to 3 months of once daily use to see results avoid product contact with eyes, lips and mouth. if contact occurs, immediately flush area with water wash hands after use"
      ],
      "ask_doctor": [
        "STOP USE AND ASK A DOCTOR IF you become pregnant, or are planning to become pregnant, while using this product you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids and shortness of breath) irritation becomes severe you see no improvement after 3 months of once daily use"
      ],
      "keep_out_of_reach_of_children": [
        "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away"
      ],
      "other_safety_information": [
        "OTHER INFORMATION Store at USP controlled room temperature 20 - 25 0 C (68 - 77 0 F) protect from freezing"
      ],
      "indications_and_usage": [
        "INDICATIONS AND USAGE Adapalene is a topical retinoid used for treating acne vulgaris"
      ],
      "recent_major_changes": [
        "Added description for indications and usage"
      ],
      "dosage_and_administration": [
        "DOSAGE AND ADMINISTRATION Apply a thin film of Adapalene Gel, 0.1% to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non-medicated soap. For topical use only. Not for ophthalmic, oral or intravaginal use."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL Carton Label - NDC 73715-003-01 Adapalene Gel, 0.1% For external use only Once daily Topical Acne Treatment Net Wt 1 oz (30 grams) Adapalene carton"
      ],
      "set_id": "22824b46-53a1-6b19-e063-6394a90a18ad",
      "id": "38e372b4-1962-e6ac-e063-6294a90af1c9",
      "effective_time": "20250701",
      "version": "2",
      "openfda": {
        "brand_name": [
          "Adapalene Gel 0.1%"
        ],
        "generic_name": [
          "ADAPALENE GEL 0.1%"
        ],
        "manufacturer_name": [
          "MOHNARK PHARMACEUTICALS INC"
        ],
        "product_ndc": [
          "73715-003"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ADAPALENE"
        ],
        "rxcui": [
          "307731"
        ],
        "spl_id": [
          "38e372b4-1962-e6ac-e063-6294a90af1c9"
        ],
        "spl_set_id": [
          "22824b46-53a1-6b19-e063-6394a90a18ad"
        ],
        "package_ndc": [
          "73715-003-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0860002324920"
        ],
        "nui": [
          "N0000175607",
          "M0018962"
        ],
        "pharm_class_epc": [
          "Retinoid [EPC]"
        ],
        "pharm_class_cs": [
          "Retinoids [CS]"
        ],
        "unii": [
          "1L4806J2QF"
        ]
      }
    }
  ]
}