Label: SUPER CHOCOLATE PRESCRIPTION- anticavity toothpaste paste, dentifrice
- NDC Code(s): 83729-103-10
- Packager: SuperMouth, LLC.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated October 14, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
-
WARNINGS AND PRECAUTIONS
WARNINGS: Do not swallow. Do not use in children under 6 years of age unless recommended by a dentist or physician. 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.
See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.
- DOSAGE & ADMINISTRATION
-
INACTIVE INGREDIENT
INACTIVE INGREDIENTS
Glycerin, Water, Hydrated Silica, *Hydroxamin® (Nano-Hydroxyapatite, Menquinone-y (Vit K2), Cholecalciferol (Vit D3)), Xylitol, Inulin, Sodium Gluconate, Methylsulfonylmethane, Xanthan Gum, Quillaja Saponaria Extract, Natural Flavor, Natural Benzoic Acid, Sodium Ascorbate (Vit C), Stevia Leaf Extract, Cranberry Seed Oil.
*Patent-Pending Formulation - PRINCIPAL DISPLAY PANEL - SuperMouth Super Chocolate Prescription Toothpaste
-
INGREDIENTS AND APPEARANCE
SUPER CHOCOLATE PRESCRIPTION
anticavity toothpaste paste, dentifriceProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:83729-103 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.1 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) MENAQUINONE 7 (UNII: 8427BML8NY) CHOLECALCIFEROL (UNII: 1C6V77QF41) XYLITOL (UNII: VCQ006KQ1E) INULIN (UNII: JOS53KRJ01) SODIUM GLUCONATE (UNII: R6Q3791S76) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) XANTHAN GUM (UNII: TTV12P4NEE) QUILLAJA SAPONARIA WHOLE (UNII: HIU9R169Y7) BENZOIC ACID (UNII: 8SKN0B0MIM) SODIUM ASCORBATE (UNII: S033EH8359) STEVIA LEAF (UNII: 6TC6NN0876) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) Product Characteristics Color brown Score Shape Size Flavor CHOCOLATE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83729-103-10 1 in 1 CARTON 10/13/2023 1 96 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/13/2023 Labeler - SuperMouth, LLC. (049384038) Registrant - SuperMouth, LLC. (049384038)
