SUPER VANILLA PRESCRIPTION- anticavity toothpaste paste, dentifrice

Super Vanilla Prescription by

Drug Labeling and Warnings

Super Vanilla Prescription by is a Prescription medication manufactured, distributed, or labeled by SuperMouth, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENT
Sodium Fluoride 1.1% (5000 ppm)

SPL UNCLASSIFIED SECTION

PURPOSE
Sodium Fluoride …. Anticavity

INACTIVE INGREDIENT

USE: This medication is used as part of a professional program for the prevention and control of dental caries. Use as directed by your health professional.

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

DIRECTIONS: Use as directed by a dentist or physician.

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 Vanilla Prescription Toothpaste

Supermouth Pro

1.1% sodium fluoride

5000 ppm

Anticavity Toothpaste

Rx Only

super vanilla

content: 1 tube 3.4oz (96g)

Dist by: SuperMouth®
9737 Aero Drive
San Diego, CA
844-MOUTHCARE
Made In The USA with
Domestic & global materials

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INGREDIENTS AND APPEARANCE

SUPER VANILLA PRESCRIPTION 
anticavity toothpaste paste, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 83729-100
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	VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83729-100-10	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)