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
res
* Please review the disclaimer below.