{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Teeth Whitening Kit Teeth Whitening Kit WATER TRIBASIC CALCIUM PHOSPHATE PHOSPHATE ION POVIDONE POTASSIUM HYDROXIDE PEPPERMINT OIL MICA SACCHARIN SODIUM TITANIUM DIOXIDE PIROCTONE OLAMINE PHTHALIMIDOPEROXYCAPROIC ACID PHTHALIMIDOPEROXYCAPROIC ACID POTASSIUM CITRATE ANHYDROUS CITRIC ACID SODIUM ACRYLOYLDIMETHYLTAURATE GLYCERIN"
      ],
      "active_ingredient": [
        "Active Ingredient Phthalimidoperoxycaproic Acid(PAP) Potassium Citrate Hydroxyapatite"
      ],
      "purpose": [
        "Purpose Teeth whitening, anti-sensitivity, remineralization"
      ],
      "indications_and_usage": [
        "Use Teeth stains from coffee, tobacco, genetic, tetracycline, food coloring, aging and other factors that may cause discoloration."
      ],
      "warnings": [
        "Warnings Don't swallow. Avoid applying gel on the gum and lips."
      ],
      "do_not_use": [
        "Do not use 1. Not suitable for ceramic or false teeth. 2. Not suitable for teeth discoloration caused by lesion or medicine. 3. Not suitable for severe tetracycline and decayed teeth. 4. Not suitable for defective enamel, exerted dentin and damaged teeth. 5. Not suitable for children under 16 years old"
      ],
      "when_using": [
        "When Using Don't swallow. Avoidapplying gel on the gum and lips."
      ],
      "stop_use": [
        "Stop Use Stop treatment when feel severe pain"
      ],
      "ask_doctor": [
        "Ask Doctor Seek doctor's advice prior to use if pregnant, breast-feeding, having gum problem or had an oral operation recently"
      ],
      "keep_out_of_reach_of_children": [
        "Keep Oot Of Reach Of Children Keep out of reach of children."
      ],
      "dosage_and_administration": [
        "Directions 1. Dry your teeth and rinse mouthpiece before use. 2. Looking in the mirror to record which stage you are with shade guide paper. 3. Twist whitening pen until the gel flows. apply the gel evenly on both upper and lower teeth. Each time use about 0.5-0.7ml. 4. Put mouthpiece into your mouth and bite it, then press power button for 1.5 seconds to start the treatment. (Tips: start with blue color, press again to turn red within 5 seconds; double press to turn red and blue within 5 seconds.) 5. The led light will turn off automatically after 16 minutes, rinse the mouthpiece and mouth with water and compare your teeth with shade guide paper again to see how many stages you have improved. 6. Don't eat or drink anything except water in 30 minutes after treatment."
      ],
      "storage_and_handling": [
        "Other information",
        "Other information Avoid sunlight and keep in dry & cool place"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Glycerin、Aqua、Polyvinylpyrrolidone(PVP)、Ammonium Acryloyldimethyltaurate/VP Copolymer、Potassium Hydroxide、Mentha Piperita (peppermint) oil 、Mica、Titanium Dioxide、Saccharin Sodium、Piroctone Olamine"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL 01"
      ],
      "set_id": "0973b73d-5de9-0986-e063-6294a90a5917",
      "id": "29c01cdf-48e8-77a6-e063-6294a90af25c",
      "effective_time": "20241220",
      "version": "2",
      "openfda": {
        "brand_name": [
          "Teeth Whitening Kit"
        ],
        "generic_name": [
          "TEETH WHITENING KIT"
        ],
        "manufacturer_name": [
          "Jiangxi Dentalbright Technology Co., Ltd"
        ],
        "product_ndc": [
          "83778-002"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PHTHALIMIDOPEROXYCAPROIC ACID",
          "POTASSIUM CITRATE",
          "TRIBASIC CALCIUM PHOSPHATE"
        ],
        "spl_id": [
          "29c01cdf-48e8-77a6-e063-6294a90af25c"
        ],
        "spl_set_id": [
          "0973b73d-5de9-0986-e063-6294a90a5917"
        ],
        "package_ndc": [
          "83778-002-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "5OEJ6FAL6C",
          "EE90ONI6FF",
          "91D9GV0Z28"
        ]
      }
    }
  ]
}