{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Ionite H Stannous Fluoride STANNOUS FLUORIDE FLUORIDE ION CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) CITRIC ACID MONOHYDRATE GLYCERIN SODIUM HYDROXIDE WATER XYLITOL"
      ],
      "active_ingredient": [
        "Active Ingredient Stannous fluoride, 0.4%"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Uses Aids in the prevention of dental cavities (caries)."
      ],
      "warnings": [
        "Warnings 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. Do not swallow. Supervision of children is required when using this product. Developing teeth of children under six years of age may become permanently discolored if excessive amounts are repeatedly swallowed.",
        "Supervision of children is required when using this product. Developing teeth of children under six years of age may become permanently discolored if excessive amounts are repeatedly swallowed."
      ],
      "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."
      ],
      "do_not_use": [
        "Do not swallow."
      ],
      "dosage_and_administration": [
        "Directions • This is not a toothpaste. Read directions carefully before using. • Adults and children 6 years of age and older: o Use once per day after brushing teeth thoroughly with toothpaste o Twist off cap to remove foil seal o Apply a small amount to a toothbrush and brush thoroughly on all tooth surfaces. o Allow the gel to remain on your teeth for 1 minute o Spit out. Do not swallow o Do not eat, drink, or rinse for at least 30 minutes • Children under 6: consult a dentist or doctor"
      ],
      "spl_unclassified_section": [
        "Other Information Store at room temperature 59 – 86°F (15 – 30°C) This product may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist",
        "Manufactured by Dharma Research, Inc. www.dharmaresearch.com 5220 N.W. 72 Avenue, Unit 15 Miami, FL 33166 1-877-833-3725"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Carbopol, citric acid, flavor, glycerin, sodium hydroxide, water, xylitol"
      ],
      "package_label_principal_display_panel": [
        "Ionite H NDC 53045-270-04 Home Care 0.4% Stannous Fluoride Gel with Xylitol Anticavity Fluoride Preventative Treatment Gel Spearmint Made in USA Gluten Free Dye Free Reorder#: 56-00130 4.3 oz. (122 g) 20150802 270 SnF2 Spmnt revB"
      ],
      "set_id": "f4c3569b-7b6a-4566-9e87-492f291c5165",
      "id": "9c407eb7-c06d-4059-83e1-a20abff762e6",
      "effective_time": "20231011",
      "version": "2",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Ionite H"
        ],
        "generic_name": [
          "STANNOUS FLUORIDE"
        ],
        "manufacturer_name": [
          "Dharma Research, Inc."
        ],
        "product_ndc": [
          "53045-270"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "STANNOUS FLUORIDE"
        ],
        "rxcui": [
          "237847"
        ],
        "spl_id": [
          "9c407eb7-c06d-4059-83e1-a20abff762e6"
        ],
        "spl_set_id": [
          "f4c3569b-7b6a-4566-9e87-492f291c5165"
        ],
        "package_ndc": [
          "53045-270-04"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3FTR44B32Q"
        ]
      }
    }
  ]
}