{
  "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,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "SprinJene Health Boost Sodium Monofluorophosphate Sodium Monofluorophosphate Fluoride Ion Water Hydrated Silica Sorbitol Xylitol Glycerin Poloxamer 407 COCAMIDOPROPYL HYDROXYSULTAINE Carboxymethylcellulose Sodium, Unspecified Zinc Citrate Zinc Oxide Sodium Lauryl Sulfoacetate Nigella Sativa Seed Oil Xanthan Gum STEVIA REBAUDIANA LEAF Minty"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Manufactured & Dist. by: Health and Natural Beauty USA Corp, Piscataway, NJ 08854"
      ],
      "active_ingredient": [
        "Active Ingredient Sodium Monofluorophosphate 0.76% (0.15% W/V fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use Helps in the prevention of cavities"
      ],
      "warnings": [
        "Warnings Keep out of reach of children under 6 years of age If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children under 6 years of age If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Supervise children as necessary until capable of using without supervision Adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day as directed by a dentist or physician. Children 2-6 years old instruct in good brushing and rinsing habits (to minimize swallowing.) Children under 2 years do not use unless directed by a dentist or physician."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Aqua, Hydrated Silica, Sorbitol, Xylitol, Glycerin, Poloxamer 407, Cocamidopropyl Hydroxysultaine, Flavor (Peppermint and Clove), Cellulose Gum, Zinc Citrate, Zinc Oxide, Sodium Lauryl Sulfoacetate (LAL), Nigella Sativa (Black Seed Oil), Xanthan Gum, Stevia Rebaudiana Extract"
      ],
      "questions": [
        "Questions or comments? Call toll free 1-844-346-2872 www.sprinjene.com"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 142 g Tube Carton SprinJene ® Fluoride Toothpaste Bursting with the unique benefits of Black Seed Oil VEGAN V BeVeg! BEVEG CERTIFIED NET WT 5.0 OZ (142 g) Health Boost Paste PRINCIPAL DISPLAY PANEL - 142 g Tube Carton"
      ],
      "set_id": "9be87bcd-403a-4d7e-8ded-9833249565d1",
      "id": "2c7c212f-b7da-47a0-bbfb-73fd530e252a",
      "effective_time": "20260814",
      "version": "4",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "SprinJene Health Boost"
        ],
        "generic_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "manufacturer_name": [
          "Health and Natural Beauty USA Corp"
        ],
        "product_ndc": [
          "63404-1108"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "rxcui": [
          "545626"
        ],
        "spl_id": [
          "2c7c212f-b7da-47a0-bbfb-73fd530e252a"
        ],
        "spl_set_id": [
          "9be87bcd-403a-4d7e-8ded-9833249565d1"
        ],
        "package_ndc": [
          "63404-1108-1",
          "63404-1108-2"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "C810JCZ56Q"
        ]
      }
    }
  ]
}