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  5. Label Information: Super Mint

FDA Label for Super Mint

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. OTHER SAFETY INFORMATION
    7. DOSAGE & ADMINISTRATION
    8. INACTIVE INGREDIENT
    9. PRODUCT LABELING: SUPER MINT FLOURIDE TOOTHPASTE

Super Mint 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



DRUG FACTS

ACTIVE INGREDIENT

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)


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


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

3.4 oz (96 g)

SuperMouth®

9737 Aero Drive,
San Diego, CA 92123
(844) MOUTHCARE

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* Please review the disclaimer below.