{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "NATEAN Clean plus Sensitivity Relief potassium nitrate, sodium fluoride WATER HYDRATED SILICA SORBITOL GLYCERIN COCAMIDOPROPYL BETAINE SODIUM COCOYL GLUTAMATE XANTHAN GUM REBAUDIOSIDE A COCONUT OIL ALOE VERA LEAF MALTODEXTRIN POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION Soothing Mint"
      ],
      "active_ingredient": [
        "Active ingredients Potassium nitrate 5% Sodium fluoride 0.25% (0.15% w/v fluoride ion)"
      ],
      "purpose": [
        "Purposes Antihypersensitivity Anticavity"
      ],
      "indications_and_usage": [
        "Uses builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities."
      ],
      "warnings": [
        "Warnings When using this product, if irritation occurs discontinue use. Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. pain/sensitivity still persists after 4 weeks of use. Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "stop_use": [
        "Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. pain/sensitivity still persists after 4 weeks of use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush. brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. Children under 12 years of age: Consult a dentist or doctor."
      ],
      "storage_and_handling": [
        "Other information do not store above 25°C (77F°)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, hydrated silica, sorbitol, glycerin, flavor, cocamidopropyl betaine, sodium cocoyl glutamate, xanthan gum, rebaudioside A, cocos nucifera (coconut) oil, aloe barbadensis leaf extract, maltodextrin"
      ],
      "questions": [
        "Questions or comments? 1-800-733-5879"
      ],
      "spl_unclassified_section": [
        "Additional Information ALWAYS FOLLOW THE LABEL Natean was created by a small passionate team of scientists and herbalists on a mission to give you the best of what nature and science can offer, while minimizing our impact to the planet. Our toothpastes expertly balance powerful, scientifically studied ingredients with botanicals for a clean you can feel, and a clean you can feel good about. NATEAN-INSPIRED BY NATURE AND DESIGNED TO BE CLEAN RELIEVES SENSITIVE TEETH AND LEAVES YOUR MOUTH FEELING CLEAN AND FRESH Infused with natural orange blossom and mint flavor, and extracts from aloe vera and coconut Contains fluoride to fight cavities Helps control tartar build-up with twice daily brushing *No animal origin materials used in the processing of these products. Contains no animal ingredients or derivatives. †Recycling facilities for this product may not exist in your area BPA-FREE TUBE Tube contains post consumer recycled plastic Recycleable carton, tube & cap Distributed by: Alacer Corp. Carlisle, PA 17013 © 2021 Alacer Corp. www.nateantoothpaste.com"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel NDC 0135-1250-01 Natean TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION NATURAL FLAVORS AND SWEETENERS NON-GMO / GLUTEN-FREE NO ARTIFICIAL PRESERVATIVES, COLORS, DYES NO SLS/TRICLOSAN VEGAN-FRIENDLY* INFUSED WITH BOTANICALS CLEAN + SENSITIVITY RELIEF SOOTHING MINT NET WT 4.7 OZ (133g) 1001587 Front Carton Natean Clean+Sensitivity Relief 4.7 OZ"
      ],
      "set_id": "cea6f992-8a44-4eb8-baea-97b7b181b227",
      "id": "14084468-126f-1f14-e063-6394a90a9c69",
      "effective_time": "20240319",
      "version": "2",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "NATEAN Clean plus Sensitivity Relief"
        ],
        "generic_name": [
          "POTASSIUM NITRATE, SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Haleon US Holdings LLC"
        ],
        "product_ndc": [
          "0135-1250"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "POTASSIUM NITRATE",
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "1086243"
        ],
        "spl_id": [
          "14084468-126f-1f14-e063-6394a90a9c69"
        ],
        "spl_set_id": [
          "cea6f992-8a44-4eb8-baea-97b7b181b227"
        ],
        "package_ndc": [
          "0135-1250-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "RU45X2JN0Z",
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}