SUPER MINT PRESCRIPTION- anticavity toothpaste paste, dentifrice 
SuperMouth, LLC.

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.

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SuperMouth Super Mint Prescription Toothpaste

ACTIVE INGREDIENT
Sodium Fluoride 1.1% (5000 ppm)

PURPOSE
Sodium Fluoride …. Anticavity

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: 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.

DIRECTIONS: Use as directed by a dentist or physician.

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 Mint Prescription Toothpaste

Supermouth Pro

1.1% sodium fluoride

5000 ppm

Anticavity Toothpaste

Rx Only

super mint

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

Mint Box

Mint Tube

res

SUPER MINT PRESCRIPTION 
anticavity toothpaste paste, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:83729-102
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorbrownScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83729-102-101 in 1 CARTON10/13/2023
196 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/13/2023
Labeler - SuperMouth, LLC. (049384038)
Registrant - SuperMouth, LLC. (049384038)

Revised: 11/2024
Document Id: 7a2b6622-cd75-4373-8cbf-38d4dd370571
Set id: 6773eb58-93b0-4e86-b780-7dde378c0bc3
Version: 2
Effective Time: 20241130
 
SuperMouth, LLC.