Label: ORTHO SUPER CHOCOLATE FLUORIDE MOUTHWASH- anticavity mouthwash liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 20, 2025

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT
    (in each 10 mL)

    Sodium Fluoride 0.02%

  • PURPOSE

    PURPOSE
    Sodium Fluoride …. Anticavity

  • INDICATIONS & USAGE

    USE

    Fluoride mouthwash

  • WARNINGS

    WARNINGS:

    Keep out of reach of children under 6 years of age.

    If more than used for
    rinsing is accidentally
    swallowed, get medical
    help or contact a
    Poison Control Center
    right away.

    Do not use if safety seal
    is broken.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    1) Shake well before using.
    2) Use daily by dispensing 10 mL, swish
        vigorously for 1 minute, and then spit out.
    3) No need to rinse.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    Water, Erythritol, Xylitol, *Hydroxamin+®
    (Nano-Hydroxyapatite, Menaquinone-7
    (Vit K2), Cholecalciferol (Vit D3)),
    Inulin, Glycerin, Sodium Gluconate, Sodium
    Bicarbonate, Methylsulfonylmethane, Natural
    Flavors, Natural Benzoic Acid,Sodium
    Ascorbate (Vit C), Xanthan Gum.

  • Product Labeling: Ortho Super Chocolate Fluoride Mouthwash

    Supermouth

    super chocolate

    fluoride mouthwash

    with hydroxamin+®

    unique formulation for orthodontics that
    reaches areas brushing & flossing don’t

    16 fl oz (473 mL)

    SuperMouth®
    9737 Aero Drive
    San Diego, CA 92123

    (844) MOUTHCARE

    Ortho Choc Floro 111

    res

  • INGREDIENTS AND APPEARANCE
    ORTHO SUPER CHOCOLATE FLUORIDE MOUTHWASH 
    anticavity mouthwash liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83729-111
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.002 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    MENAQUINONE 7 (UNII: 8427BML8NY)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    INULIN (UNII: JOS53KRJ01)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorCHOCOLATEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83729-111-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product02/20/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/20/2024
    Labeler - SuperMouth, LLC. (049384038)
    Registrant - SuperMouth, LLC. (049384038)
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