{
  "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": "2026-10-13",
    "results": {
      "skip": 0,
      "limit": 100,
      "total": 4
    }
  },
  "results": [
    {
      "effective_time": "20150108",
      "inactive_ingredient": [
        "Ingredients Sorbitol, Dicalcium Phosphate, Glycerin, Hydrated Silica, Dextrose Monohydrate, Silica, Isoceteth-20, Xylitol, Water, Cellulose Gum, Sodium Benzoate, Lactoperoxidase , Mentha Piperita (Peppermint Oil-includes limonene), Potassium Thiocyanate, Menthol, Lactoferrin , Lysozyme, Glucose Oxidase, Calcium Lactate"
      ],
      "purpose": [
        "Purpose Anti-cavity"
      ],
      "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. If symptoms of dry mouth persist, consult a health care professional."
      ],
      "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. If symptoms of dry mouth persist, consult a health care professional. DO NOT use if you are allergic to any of the ingredients."
      ],
      "questions": [
        "Questions or Comments? Call Tel. : 908-420-3759 weekdays or, email us: info@fountainhealthcarellc.com"
      ],
      "spl_product_data_elements": [
        "Oral7 SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION SORBITOL CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS GLYCERIN HYDRATED SILICA DEXTROSE MONOHYDRATE SILICON DIOXIDE ISOCETETH-20 XYLITOL WATER CARBOXYMETHYLCELLULOSE SODIUM SODIUM BENZOATE MYELOPEROXIDASE MENTHA PIPERITA POTASSIUM THIOCYANATE MENTHOL, UNSPECIFIED FORM LACTOFERRIN, BOVINE LYSOZYME GLUCOSE OXIDASE CALCIUM LACTATE TO OFF WHITE"
      ],
      "openfda": {},
      "version": "1",
      "dosage_and_administration": [
        "Directions Adults and Children 2 years of age and older Use 2-3 times a day, 7 days a week. Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a doctor or dentist Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor."
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "storage_and_handling": [
        "Other Information Store below 77°F (25°C)."
      ],
      "do_not_use": [
        "DO NOT use if you are allergic to any of the ingredients."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 105 g Tube Carton NDC 69297-000-19 Oral 7 ® Xylitol balancing your mouth's natural flora Beneficial for the whole family! ✓ No SLS ( harsh drying detergent ) ✓ With Fluoride & Calcium ✓ Extra Beneficial for Dry Mouth MOISTURIZING TOOTHPASTE With natural enzymes to help reinforce your mouth's own defense system 75mL (105g) e PRINCIPAL DISPLAY PANEL - 105 g Tube Carton"
      ],
      "indications_and_usage": [
        "Use Aids in the prevention of dental cavities."
      ],
      "set_id": "5c92500d-d151-44c9-9cea-81e89adae9dd",
      "id": "8ea5587b-2e5f-4c89-8ba5-04d94eb8eaa0",
      "active_ingredient": [
        "Active Ingredient Sodium Monofluorophosphate 0.76% w/w (1000ppmF)"
      ]
    },
    {
      "effective_time": "20091016",
      "inactive_ingredient": [
        "Inactive ingredients calcium lactate, sea salt, silica, sodium sulfate"
      ],
      "purpose": [
        "Active Ingredients Purposes Potassium bicarbonate (7.8%) Antacid Sodium bicarbonate (78%) Antacid Sodium citrate (1.6%) Antacid"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children."
      ],
      "warnings": [
        "Warnings Ask a doctor or pharmacist before use if you have kidney disease or are on a sodium-restricted diet. if you are taking a prescription drug. Antacids may interact with certain prescription drugs. if you are pregnant or nursing a baby. Stop use and ask a doctor if symptoms or maximum dosage lasts more than 2 weeks. may have laxative effect or cause constipation in some users. Keep out of reach of children."
      ],
      "spl_product_data_elements": [
        "Pleo Alkala Antacid sodium bicarbonate, potassium bicarbonate and sodium citrate sodium bicarbonate sodium cation potassium bicarbonate potassium cation sodium citrate sodium cation calcium lactate sea salt sodium sulfate"
      ],
      "openfda": {},
      "version": "1",
      "dosage_and_administration": [
        "Directions Use enclosed spoon. Take one spoonful in the morning with a glass of water. If needed, take a second spoonful in the evening, or as directed by a doctor. Do not take more than 2 spoonfuls in a 24-hour period. If you are over 60 years old, do not take more than 1 spoonful. Not for children under 12 years. Do not take maximum dose for more than 2 weeks."
      ],
      "spl_unclassified_section": [
        "5.3 oz (150 g)",
        "Drug Facts",
        "Rev. 03/2007 Made in Germany by Sanum-Kehlbeck GmbH Germany Distributed by: SANUM USA Corp. 1465 Slater Road, Ferndale, WA 98248"
      ],
      "stop_use": [
        "Stop use and ask a doctor if symptoms or maximum dosage lasts more than 2 weeks. may have laxative effect or cause constipation in some users."
      ],
      "storage_and_handling": [
        "Other information Do not use after expiration date. Store at room temperature. Protect from heat and light. Sodium per spoonful 1500 mg. Potassium per spoonful 190 mg."
      ],
      "do_not_use": [
        "Tamper Evident This container has been designed for your safety to ensure product freshness. Do not use after expiration date. Do not use if the seal between the cap and container is broken or missing or imprinted security strip on carton is torn."
      ],
      "active_ingredient_table": [
        "<table width=\"50%\"> <col width=\"80%\" align=\"left\" valign=\"middle\"/> <col width=\"20%\" align=\"right\" valign=\"middle\"/> <thead> <tr styleCode=\"Toprule Botrule\"> <th> <content styleCode=\"italics\">Active Ingredients</content> </th> <th> <content styleCode=\"italics\">Purposes</content> </th> </tr> </thead> <tbody> <tr styleCode=\"Toprule\"> <td>Potassium bicarbonate (7.8%)</td> <td>Antacid</td> </tr> <tr> <td>Sodium bicarbonate (78%)</td> <td>Antacid</td> </tr> <tr styleCode=\"Botrule\"> <td>Sodium citrate (1.6%)</td> <td>Antacid</td> </tr> </tbody> </table>"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 150 g Carton \"The Original\" Pleo™ Alkala Antacid Powder 5.3 oz (150 g) Principal Display Panel - 150 g Carton"
      ],
      "indications_and_usage": [
        "Uses Relieves: Heartburn Sour stomach Acid indigestion Upset stomach associated with these symptoms"
      ],
      "set_id": "7dca3271-4810-45d0-8b02-0bb0941bcc6f",
      "id": "10098eed-072a-409e-8873-02a570e3c285",
      "purpose_table": [
        "<table width=\"50%\"> <col width=\"80%\" align=\"left\" valign=\"middle\"/> <col width=\"20%\" align=\"right\" valign=\"middle\"/> <thead> <tr styleCode=\"Toprule Botrule\"> <th> <content styleCode=\"italics\">Active Ingredients</content> </th> <th> <content styleCode=\"italics\">Purposes</content> </th> </tr> </thead> <tbody> <tr styleCode=\"Toprule\"> <td>Potassium bicarbonate (7.8%)</td> <td>Antacid</td> </tr> <tr> <td>Sodium bicarbonate (78%)</td> <td>Antacid</td> </tr> <tr styleCode=\"Botrule\"> <td>Sodium citrate (1.6%)</td> <td>Antacid</td> </tr> </tbody> </table>"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you have kidney disease or are on a sodium-restricted diet. if you are taking a prescription drug. Antacids may interact with certain prescription drugs. if you are pregnant or nursing a baby."
      ],
      "active_ingredient": [
        "Active Ingredients Purposes Potassium bicarbonate (7.8%) Antacid Sodium bicarbonate (78%) Antacid Sodium citrate (1.6%) Antacid"
      ]
    },
    {
      "effective_time": "20141025",
      "inactive_ingredient": [
        "water, butylene glycol, sea water, xanthan gum, hydrolyzed collagen, calcium lactate, polyglutamic acid, etc"
      ],
      "purpose": [
        "skin protectant"
      ],
      "keep_out_of_reach_of_children": [
        "keep out or reach of the children"
      ],
      "warnings": [
        "-If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately -This product is for exeternal use only. Do not use for internal use -If possible, avoid direct sunlight and store in cool and area of low humidity -In order to maintain the quality of the product and avoid misuse -Avoid placing the product near fire and store out in reach of children"
      ],
      "spl_product_data_elements": [
        "M-Rose Seaweed Hydrogel Mask ALLANTOIN ALLANTOIN ALLANTOIN WATER BUTYLENE GLYCOL HYALURONATE SODIUM"
      ],
      "openfda": {},
      "version": "1",
      "dosage_and_administration": [
        "for external use only"
      ],
      "package_label_principal_display_panel": [
        "package label"
      ],
      "indications_and_usage": [
        "1. First, cleanse your face and apply serum and emulsion. Then place the mask pack over the entire forehead nose to a thickness of about 1 mm. 2. Smooth along the jaw line. 3. Place over the cheeks and around the mouth. When the mask has completely dried (approximately 15-20 minutes), gently peel off from the chin. 4. Press the face with both palms from the center toward the outer edge of the face, pressing the skin lightly. 5. With fingertips, press on the areas around the eyes and the mouth, starting from the center of the face and moving outward."
      ],
      "set_id": "c151e552-9aea-4a31-8e0e-4ec6daab3fd6",
      "id": "53c0f923-8980-4865-9f2a-a4e71e2fab77",
      "active_ingredient": [
        "allantoin"
      ]
    },
    {
      "effective_time": "20110929",
      "inactive_ingredient": [
        "Inactive ingredients acesulfame K, calcium lactate, calcium pyrophosphate, cellulose gum, flavor, beta-D-glucose, glycerin, hydrated silica, isoceteth-20, lactoferrin, potassium thiocyanate, purified water, sodium benzoate, sorbitol, xylitol. Enzyme System: glucose oxidase, lactoperoxidase, lysozyme"
      ],
      "purpose": [
        "Purpose Antihypersensitivity Anticavity"
      ],
      "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."
      ],
      "warnings": [
        "Warnings If pain/sensitivity still persists after 4 weeks of use, please visit your dentist. 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. 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."
      ],
      "questions": [
        "Questions or comments? call toll-free 1-800-922-5856 weekdays"
      ],
      "spl_product_data_elements": [
        "BIOTENE Sensitive potassium nitrate and sodium monofluorophosphate POTASSIUM NITRATE POTASSIUM CATION SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION ACESULFAME POTASSIUM CALCIUM LACTATE CALCIUM PYROPHOSPHATE CARBOXYMETHYLCELLULOSE SODIUM .BETA.-D-GLUCOPYRANOSE GLYCERIN HYDRATED SILICA CETETH-20 TALACTOFERRIN ALFA POTASSIUM THIOCYANATE WATER SODIUM BENZOATE SORBITOL XYLITOL GLUCOSE OXIDASE LACTOPEROXIDASE BOVINE LYSOZYME, CHICKEN EGG WHITE"
      ],
      "openfda": {},
      "version": "2",
      "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 one minute, preferable after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: consult a dentist or physician"
      ],
      "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."
      ],
      "storage_and_handling": [
        "Other Information store below 25°C (77°F)"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel biotene ® Sensitive MULTI-PROTECTION FORMULA Fluoride Toothpaste for SENSITIVE TEETH & Cavity Prevention Relieves Pain & Discomfort WITH GENTLE DRY MOUTH PROTECTION NET WT 3.5 OZ (99.2g) #1 DENTIST & HYGIENIST RECOMMENDED BRAND FOR DRY MOUTH #1 RECOMMENDED DRY MOUTH BRAND Supplements saliva's natural defenses and strengthens teeth With Regular Brushing Builds Increasing protection against painful sensitivty. Maximum Strength formula soothes the nerves in your teeth where dentis is exposed. Clinically Proven to relieve dry mouth* Gentle Formula does not contain sodium lauryl sulfate. PATENTED SALIVARY LP3™ ENZYME SYSTEM *when used in combination with oral balance ® Gel TRIPLE ENZYME PROTECTION Lactoperoxidase Glucose Oxidase Lysozyme biotene ® Sensitive Toothpaste combines #1 recommended ingredient to reduce painful sensitivity with #1Dentist &Hygienist Recommened Brand for Dry Mouth Helpful to dry mouth sufferers having difficulties maintaining good oral hygiene This product contains no saccharin. No sodium lauryl sulfate (SLS) biotene ® , oralbalance ® , Salivary LP3 Enzyme System™ and various graphic elements are trademarks of the GlaxoSmithKline group of companies. Xylitol ® is a trademark of Danisco Sweetners Oy www.biotene.com Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 ©2010 GlaxoSmithKline Naturally sweetened with Xylitol ® 000000XX Biotene Sensitive carton"
      ],
      "indications_and_usage": [
        "Uses builds increasing protection against painful sensitivity of the teeth due to cold, heat , acids, sweets, or contact aids in the prevention of dental cavities"
      ],
      "set_id": "cfeae7f3-4969-4e02-8d07-e9449ab37e20",
      "id": "f3d00a3e-471c-46c7-bc96-816d8f481b5e",
      "active_ingredient": [
        "Active ingredients Potassium nitrate (5.0%) Sodium Monofluorophosphate (014% w/v fluoride ion)"
      ]
    }
  ]
}