Otc - Active Ingredient
DRUG FACTS
ACTIVE INGREDIENT
Sodium Fluoride 0.24% (0.15% w/v fluoride ion)
Super Mint Paste, Dentifrice
FDA Label NDC 83729-121
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 Super Mint (NDC 83729-121). 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
Anticavity Toothpaste
Indications & Usage
USE
Aids in the prevention of cavities
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 brushing is accidentally swallowed, get medical help or
contact a Poison Control Center right away.
ALWAYS FOLLOW LABEL *patented formulation
Dosage & Administration
DIRECTIONS
- Children under 3 yrs: use no more than a tiny grain-of-rice smear.
- Children between 3 and 6: use only a pea sized amount.
• Place product on SuperMouth® toothbrush and brush teeth thoroughly at least
twice a day for 2 minutes or use as directed by a Dentist or Physician. Supervise
child’s brushing and rinsing to minimize swallowing.
Inactive Ingredient
INACTIVE INGREDIENTS Glycerin, Water, Hydrated Silica, *Hydroxamin®
(Nano-Hydroxyapatite, Menaquinone-7 (Vitamin K2), Cholecalciferol (Vitamin D3)),
Xylitol, Inulin, Natural Flavors, Sodium Gluconate, Methylsulfonylmethane, Xanthan
Gum, Quillaja Saponaria Extract, Sodium Methyl Cocoyl Taurate, Natural Benzoic
Acid, Sodium Ascorbate (Vitamin C), Stevia Leaf Extract, Cranberry Seed Oil.
Product Labeling: Super Mint Flouride Toothpaste
..........................................................................
Supermouth
super mint
fluoride toothpaste
safe • effective • fun
4.5 oz (128 g)
SuperMouth®
9737 Aero Drive,
San Diego, CA 92123 U.S.A.
(844) MOUTHCARE
res
* Please review the disclaimer below.
