Dubai Chocolate Flavor Paste, Dentifrice
FDA Label NDC 83729-119

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 Flavor (NDC 83729-119). 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 - 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, Sodium Gluconate, Natural Flavors**, Methylsulfonylmethane, Xanthan Gum,
Cacao Powder, Quillaja Saponaria Extract, Natural Benzoic Acid, Sodium Ascorbate
(Vitamin C), Stevia Leaf Extract, Cranberry Seed Oil, Sodium Methyl Cocoyl Taurate

Product Labeling: Dubai Chocolate Flavor Toothpaste

..........................................................................

Supermouth

dubai chocolate

    flavor

fluoride toothpaste

safe • effective • fun

3.4 oz (96 g)

SuperMouth®

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

Carton Label

Tube Label

res

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