{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "twice. Oral Wellness Gum Shield Cetylpyridinium Chloride CITRIC ACID DISODIUM PHOSPHATE LEMON OIL WATER POLOXAMER 407 SPEARMINT OIL CETYLPYRIDINIUM CHLORIDE CETYLPYRIDINIUM GLYCERIN STEVIA LEAF"
      ],
      "active_ingredient": [
        "Active ingredient Cetylpyridinium Chloride 0.05%"
      ],
      "purpose": [
        "Purpose Antigingivitis/Antiplaque mouthrinse"
      ],
      "indications_and_usage": [
        "Uses Helps prevent gingivitis, an early form of gum disease, and bleeding gums Helps control plaque that lead to gingivitis and bleeding gums"
      ],
      "warnings": [
        "Warnings Warnings"
      ],
      "stop_use": [
        "Stop use and ask a dentist if Gingivitis, bleeding, or redness persists for more than 2 weeks You have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)."
      ],
      "other_safety_information": [
        "Other information This rinse is not intended to replace brushing or flossing, Do not use if printed safety seal on the bottle's neck is broken or missing, Recommended storage temperature 59°F-77°F (15°C-25°C)"
      ],
      "dosage_and_administration": [
        "Directions Adults and children 12 years of age and older: Vigorously swish 20 mL of rinse between your teeth a day for 30 seconds and then split it our. Do not swallow the rinse. Children 6 years to under 12 yaers: Supervise use. Children under 6 years: Do not use."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Citric Acid, Disodium Phosphate, Glycerin, Lemon Oil, Poloxamer 407, Spearmint Oil, Stevia Leaf Extract, Water"
      ],
      "package_label_principal_display_panel": [
        "00839"
      ],
      "set_id": "3d48e2f6-99b6-e8bc-e063-6294a90a1afc",
      "id": "4e81d963-f1ce-c398-e063-6394a90a6fd1",
      "effective_time": "20260402",
      "version": "3",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "twice. Oral Wellness Gum Shield"
        ],
        "generic_name": [
          "CETYLPYRIDINIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Twice Twice LLC"
        ],
        "product_ndc": [
          "72164-009"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CETYLPYRIDINIUM CHLORIDE"
        ],
        "rxcui": [
          "1251617"
        ],
        "spl_id": [
          "4e81d963-f1ce-c398-e063-6394a90a6fd1"
        ],
        "spl_set_id": [
          "3d48e2f6-99b6-e8bc-e063-6294a90a1afc"
        ],
        "package_ndc": [
          "72164-009-20"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0854679008399"
        ],
        "unii": [
          "D9OM4SK49P"
        ]
      }
    }
  ]
}