{
  "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": "2026-10-14",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Neutrogena Adapalene 0.1% Acne Treatment Adapalene METHYLPARABEN HYDROCHLORIC ACID SODIUM HYDROXIDE CARBOMER HOMOPOLYMER TYPE C ADAPALENE ADAPALENE PROPYLENE GLYCOL EDETATE DISODIUM POLOXAMER 182 WATER"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558"
      ],
      "active_ingredient": [
        "Active ingredient Adapalene, USP 0.1% (retinoid)* *read consumer information leaflet"
      ],
      "purpose": [
        "Purpose Acne treatment"
      ],
      "indications_and_usage": [
        "Use For the treatment of acne"
      ],
      "warnings": [
        "Warnings For external use only Do not use ▪on damaged skin (cuts, abrasions, eczema, sunburn) ▪ if you are allergic to adapalene or any of the ingredients in this product If pregnant or breast-feeding, ask a doctor before use. 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 get irritation that becomes severe ▪ irritation (redness, itching, dryness, burning) is more likely to occur: ▪ in the first few weeks of use ▪ if using 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 the eyes, lips, and mouth. If contact occurs, immediately flush the area with water. ▪ wash hands after use Stop use and ask a doctor if ▪ you become pregnant, or are planning to become pregnant while using the 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. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "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"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a doctor before use."
      ],
      "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 get irritation that becomes severe ▪ irritation (redness, itching, dryness, burning) is more likely to occur: ▪ in the first few weeks of use ▪ if using 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 the eyes, lips, and mouth. If contact occurs, immediately flush the area with water. ▪ wash hands after use"
      ],
      "stop_use": [
        "Stop use and ask a doctor if ▪ you become pregnant, or are planning to become pregnant while using the 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 (1-800-222-1222) right away."
      ],
      "dosage_and_administration": [
        "Directions Directions Adults and children 12 years of age 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 or better results, but may worsen skin irritation. Children under 12 years of age: ask a doctor"
      ],
      "storage_and_handling": [
        "Other Information ▪ store at room temperature 68° to 77°F ▪ protect from freezing"
      ],
      "inactive_ingredient": [
        "Inactive ingredients carbomer homopolymer type C, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water May contain hydrochloric acid and/or sodium hydroxide to adjust pH."
      ],
      "questions": [
        "Questions or comments? Call 800-582-4048; Outside US, dial collect 215-273-8755 or visit www.neutrogena.com"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 45 g Tube Carton Neutrogena ® DERMATOLOGIST RECOMMENDED BRAND NEW Adapalene Gel 0.1% Acne Treatment Previously available only By prescription Dermatologist developed & tested Once Daily Topical Retinoid* Oil Free Fragrance Free *Read consumer information leaflet before use NET WT 1.6 OZ (45 g) Neutrogena_01"
      ],
      "set_id": "0682cb55-6ae3-437f-e063-6294a90ac510",
      "id": "21bf71d1-8aea-5bec-e063-6294a90aed2c",
      "effective_time": "20241112",
      "version": "2",
      "openfda": {
        "application_number": [
          "ANDA090962"
        ],
        "brand_name": [
          "Neutrogena Adapalene 0.1% Acne Treatment"
        ],
        "generic_name": [
          "ADAPALENE"
        ],
        "manufacturer_name": [
          "Kenvue Brands LLC"
        ],
        "product_ndc": [
          "69968-0826"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ADAPALENE"
        ],
        "rxcui": [
          "307731"
        ],
        "spl_id": [
          "21bf71d1-8aea-5bec-e063-6294a90aed2c"
        ],
        "spl_set_id": [
          "0682cb55-6ae3-437f-e063-6294a90ac510"
        ],
        "package_ndc": [
          "69968-0826-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0070501067659"
        ],
        "nui": [
          "N0000175607",
          "M0018962"
        ],
        "pharm_class_epc": [
          "Retinoid [EPC]"
        ],
        "pharm_class_cs": [
          "Retinoids [CS]"
        ],
        "unii": [
          "1L4806J2QF"
        ]
      }
    }
  ]
}