FDA Label for Ortho Super Mint Fluoride Mouthwash

View Indications, Usage & Precautions

Ortho Super Mint Fluoride Mouthwash Product Label

The following document was submitted to the FDA by the labeler of this product Supermouth, Llc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



ACTIVE INGREDIENT
(in each 10 mL)

Sodium Fluoride 0.02%


Otc - Purpose



PURPOSE
Sodium Fluoride …. Anticavity


Indications & Usage



USE

Fluoride mouthwash


Warnings



WARNINGS:


Otc - Keep Out Of Reach Of Children



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


Other Safety Information



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, Natural
Flavors, Sodium Bicarbonate, Methyl
-sulfonylmethane, Natural Benzoic Acid,
Sodium Ascorbate (Vit C), Xanthan Gum.


Product Labeling: Ortho Super Mint Fluoride Mouthwash



Supermouth

super mint

fluoride mouthwash

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

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* Please review the disclaimer below.