{
  "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",
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  "results": [
    {
      "spl_product_data_elements": [
        "Northside Hospital Mothers Kit, Grey Backpack ALCOHOL and SODIUM MONOFLUOROPHOSPHATE ETHYL ALCOHOL ALCOHOL ALCOHOL ALCOHOL Water Aloe Vera Leaf Glycerin Propylene Glycol ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S AT 0.5%) FRAGRANCE 13576 DeCure SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE Fluoride Ion CALCIUM CARBONATE Water Sorbitol Sodium Lauryl Sulfate SODIUM PYROPHOSPHATE SACCHARIN SODIUM SILICON DIOXIDE SODIUM SILICATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED XANTHAN GUM BENZYL ALCOHOL Sodium Benzoate METHYL SALICYLATE Algard Water Edetate Disodium XANTHAN GUM Glycerin Titanium Dioxide Petrolatum Glyceryl Monostearate LIGHT MINERAL OIL Dimethicone .ALPHA.-TOCOPHEROL ACETATE Phenoxyethanol TROLAMINE Sodium Lauroyl Lactylate Butylated Hydroxytoluene CETOSTEARYL ALCOHOL FRAGRANCE 13576 Algard Water Edetate Disodium GLYCERIN DISODIUM LAURETH SULFOSUCCINATE COCO MONOETHANOLAMIDE GLYCOL DISTEARATE BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) COCO DIETHANOLAMIDE SODIUM LAURYL SARCOSINATE COCAMIDOPROPYL BETAINE PHENOXYETHANOL OLIVE OIL OLEA EUROPAEA (OLIVE) LEAF POWDER POLYQUATERNIUM-39 (35/35/30 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1500000 MW) POLYQUATERNIUM-73 POLYQUATERNIUM-10 (20000 MPA.S AT 2%) TROLAMINE FRAGRANCE 13576 Algard Water EDETATE DISODIUM Xanthan Gum Glycerin BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) DISODIUM LAURETH SULFOSUCCINATE SODIUM LAURYL SARCOSINATE COCO DIETHANOLAMIDE COCAMIDOPROPYL BETAINE PHENOXYETHANOL POLYSORBATE 20 TROLAMINE FRAGRANCE 13576 ASP Lip Balm 2-ETHYLHEXYL ISOHEXADECANOATE MEDIUM-CHAIN TRIGLYCERIDES POLYISOBUTYLENE (2300 MW) YELLOW WAX HIGH DENSITY POLYETHYLENE SHEA BUTTER .ALPHA.-TOCOPHEROL ACETATE PHENOXYETHANOL FRAGRANCE 13576 Algard Hair Conditioner Water GLYCERIN CETOSTEARYL ALCOHOL SHEA BUTTER CETRIMONIUM CHLORIDE BEHENTRIMONIUM CHLORIDE ALMOND OIL JOJOBA OIL FRAGRANCE 13576 GLYCERYL STEARATE/PEG-100 STEARATE POLYQUATERNIUM-7 (76/24 ACRYLAMIDE/DADMAC; 120000 MW) POLYQUATERNIUM-73 ARGAN OIL BUTYLATED HYDROXYTOLUENE EDETATE DISODIUM TROLAMINE POLYQUATERNIUM-39 (35/35/30 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1500000 MW) PHENOXYETHANOL"
      ],
      "spl_unclassified_section": [
        "Instant Hand Antiseptic DRUG FACTS",
        "DISTRIBUTED BY: ASP GLOBAL, LLC 7800 THIRD FLAG PARKWAY, AUSTELL, GA 30168, USA",
        "DeCure Toothpaste Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredient Ethyl Alcohol I.P. :",
        "Active Ingredient Sodium Monofluorophosphate 0.76%"
      ],
      "purpose": [
        "70.0% v/v Gel base",
        "Purpose Anticavity (Total Fluoride Content - 1000 ppm Approx.)"
      ],
      "indications_and_usage": [
        "USES Hand Sanitization to decrease bacteria on the skin. For use when soap and water are not available.",
        "Uses Regular brushing with Fluoride toothpaste helps protect teeth roots against cavities."
      ],
      "warnings": [
        "WARNINGS Flammable. Keep away from fire or flame. For external use only. Recommended for repeated use. WHEN USING THE PRODUCT Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. STOP USE AND ASK A DOCTOR IF Irritation or rash appears, Keep out of reach of children. If swallowed, get medical help or call a poison control center.",
        "Warnings Keep out of reach of children under 6 years of age. Don't use if irritation occurs and persists. If more than used for brushing is accidentally swallowed, get medical help, or contact a Poison Control Center right away."
      ],
      "when_using": [
        "WHEN USING THE PRODUCT Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water."
      ],
      "stop_use": [
        "STOP USE AND ASK A DOCTOR IF Irritation or rash appears,"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or call a poison control center.",
        "Keep out of reach of children under 6 years of age."
      ],
      "dosage_and_administration": [
        "DIRECTIONS Not recommended for infants. Wet hands thoroughly with product & allow to self dry. Children under 6 years of age should be supervised when using this product.",
        "Directions Adults & 6+ Children Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician Children under 6 yrs. To minimize swallowing use a pea - sized amount and supervise brushing. Children under 2 yrs. Ask a dentist or physician. NDC NO. 84132-100-10"
      ],
      "storage_and_handling": [
        "OTHER INFORMATION Avoid freezing, Do not store above 40°C ( 104°F )."
      ],
      "inactive_ingredient": [
        "INGREDIENTS Ultrez - 20. Glycerin, Propylene Glycol, Ethyl Alcohol, Aloe Vera Juice, Fragrance & Purified Water.",
        "Inactive Ingredients Calcium Carbonate, Water, Sorbitol, Silica, Sodium Lauryl Sulphate, Flavor, Sodium Silicate, Tetra Sodium Pyrophosphate, Cellulose Gum, Xanthan Gum, Benzyl Alcohol, Sodium Saccharin, Sodium Benzoate"
      ],
      "do_not_use": [
        "Don't use if irritation occurs and persists. If more than used for brushing is accidentally swallowed, get medical help, or contact a Poison Control Center right away."
      ],
      "dosage_and_administration_table": [
        "<table width=\"75%\"><col width=\"25%\" align=\"left\" valign=\"middle\"/><col width=\"35%\" align=\"left\" valign=\"middle\"/><col width=\"40%\" align=\"left\" valign=\"middle\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">Adults &amp; 6+ Children</td><td styleCode=\"Rrule\" colspan=\"2\">Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">Children under 6 yrs.</td><td styleCode=\"Rrule\" colspan=\"2\">To minimize swallowing use a pea - sized amount and supervise brushing.</td></tr><tr><td styleCode=\"Lrule Rrule\">Children under 2 yrs.</td><td styleCode=\"Rrule\"> Ask a dentist or physician. </td><td styleCode=\"Rrule\"><content styleCode=\"bold\">NDC NO. 84132-100-10</content></td></tr></tbody></table>"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label ASP GLOBAL INSTANT Hand Antiseptic 70.0% Ethyl Alcohol 1.9 FL OZ / 53 mL PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label",
        "PRINCIPAL DISPLAY PANEL - 10 gms Tube Label DeCure Net Weight 10gms / 0.35oz Toothpaste With Fluoride Anticavity Protection PRINCIPAL DISPLAY PANEL - 10 gms Tube Label",
        "PRINCIPAL DISPLAY PANEL - Kit Label NORTHSIDE HOSPITAL Mother's Bag NSMTKTV01-GB Creating a Healing Environment We provide our patients with the essentials they need to stay well rested. This is an important part of healing, both here and at home. Contents/Origins(On Back) Northside Amenity Kit - Main includes: 2.0 fl.oz. Shampoo/Conditioner, 2.0 fl.oz. Body Wash, 2.0 fl.oz. Body Lotion, 2.0 fl.oz. Alcohol-free Mouthwash, 1.9 fl.oz. Hand Sanitizer, 0.15 oz. net wt. Lip Balm, Hairbrush, Toothbrush, Toothpaste, Ear Plugs, Eye Mask, Face Mask, Facial Tissue, Pen, Puzzle Book, Questions for My Care Team Book Insulated Bag Kit includes: 2 Ice Packs, 2 Baby Bottles, 1 Spoon Insulated Mug includes: 1 Insulated Mug with Lid and Straw, 30 oz. Disposable Panties/Briefs includes: 6 Disposable Panties/ Briefs Sanitary Pad includes: 6 Sanitary Pads, 6.5\" x 13.5\" Cleansing Bottle includes: 1 Cleansing Bottle, 8 oz. Cup includes: 1 Cup, 8 oz. Perineal Instant Cold Pack Includes: 4 Perineal Instant Cold Packs, 4.5\" x 14.25\" Distributed by: ASP Global, LLC 7800 Third Flag Parkway, Austell, GA 30168, USA REV 00 Components Made in China: Shampoo/Conditioner, Body Wash, Body Lotion, Alcohol-Free Mouthwash, Lip Balm, Hand Sanitizer, Hairbrush, Toothbrush, Toothpaste, Ear Plugs, Eye Mask, Face Mask, Facial Tissue, Pen, Puzzle Book, Questions for My Care Team Book, Ice Pack, Baby Bottle, Spoon, Cup, Insulated Mug, Insulated Bag Kit, Sanitary Pad, Disposable Panties/Briefs, Cleansing Bottle, Perineal Instant Cold Pack Component Made in India: Mother's Bag (Backpack) Assembled in the USA Lot #: XMMDDFC Exp: YYYY-MM-DD 1000 Johnson Ferry Rd NE. Atlanta, GA 30342 Tel: (404) 851-8000 NORTHSIDE HOSPITAL Item #: NSMTKTV01-GB Description: KIT, NORTHSIDE VAGINAL MOTHERS, GREY BACKPACK PO #: XXXXXXXXX Lot #: XMMDDFC Exp: YYYY-MM-DD Qty: 6 KIT/CS Carton #: XXX of XXX Net Wt.: XX KG Gross Wt.: XX KG Cubic Dimensions: 23 x 18 x 16 INCH Components Made in China: Shampoo/Conditioner, Body Wash, Body Lotion, Alcohol-Free Mouthwash, Lip Balm, Hand Sanitizer, Hairbrush, Toothbrush, Toothpaste, Ear Plugs, Eye Mask, Face Mask, Facial Tissue, Pen, Puzzle Book, Questions for My Care Team Book, Ice Pack, Baby Bottle, Spoon, Cup, Insulated Bag Kit, Sanitary Pad, Disposable Panties/Briefs, Cleansing Bottle, Perineal Instant Cold Pack, Cable Tie Components Made in India: Mother's Bag (Backpack) Assembled in the USA NORTHSIDE HOSPITAL NORTHSIDE HOSPITAL PRINCIPAL DISPLAY PANEL - Kit Label"
      ],
      "set_id": "0868060e-d593-4cb2-b3d2-6c59d1ae5efc",
      "id": "c9b30ee1-66b2-411d-8a05-ee58c813db5c",
      "effective_time": "20250929",
      "version": "1",
      "openfda": {
        "application_number": [
          "M003"
        ],
        "brand_name": [
          "Northside Hospital Mothers Kit, Grey Backpack"
        ],
        "generic_name": [
          "ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE"
        ],
        "manufacturer_name": [
          "ASP Global, LLc"
        ],
        "product_ndc": [
          "59448-214"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "rxcui": [
          "545626",
          "581662"
        ],
        "spl_id": [
          "c9b30ee1-66b2-411d-8a05-ee58c813db5c"
        ],
        "spl_set_id": [
          "0868060e-d593-4cb2-b3d2-6c59d1ae5efc"
        ],
        "package_ndc": [
          "59448-214-00",
          "59448-011-01",
          "84132-100-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "8906079548707"
        ]
      }
    }
  ]
}