Otc - Active Ingredient
ACTIVE INGREDIENT
(in each 10 mL)
Sodium Fluoride 0.02%
Dubai Chocolate Fluoride Mouthwash Liquid
FDA Label NDC 83729-120
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Supermouth, Llc. for the product Dubai Chocolate Fluoride Mouthwash (NDC 83729-120). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, other safety information, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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, Sodium
Bicarbonate, Natural Flavors**, Methyl-
sulfonylmethane, Natural Benzoic Acid,
Sodium Ascorbate (Vit C), Xanthan Gum.
*Patented Formulation
**Flavor only - no actual chocolate or Dubai ingredients used.
Product Labeling: Dubai Chocolate Fluoride Mouthwash
Supermouth
dubai chocolate
flavor
fluoride mouthwash
safe • effective • fun
16 fl oz (473 mL)
reaches areas brushing & flossing don’t and prevents bad breath
SuperMouth®
9737 Aero Drive
San Diego, CA 92123
(844) MOUTHCARE
res
* Please review the disclaimer below.
