DRUG FACTS

ACTIVE INGREDIENT

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

PURPOSE
Anticavity Toothpaste

USE

Aids in the prevention of cavities

WARNINGS

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or
contact a Poison Control Center right away.

ALWAYS FOLLOW LABEL

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 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

Dubai thpaste box

Tube Label

Dubai Chocolate - tube

res

DUBAI CHOCOLATE FLAVOR
anticavity toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83729-119
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.4 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
MENAQUINONE 7 (UNII: 8427BML8NY)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
XYLITOL (UNII: VCQ006KQ1E)
INULIN (UNII: JOS53KRJ01)
SODIUM GLUCONATE (UNII: R6Q3791S76)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
XANTHAN GUM (UNII: TTV12P4NEE)
COCOA (UNII: D9108TZ9KG)
QUILLAJA SAPONARIA WHOLE (UNII: HIU9R169Y7)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM ASCORBATE (UNII: S033EH8359)
STEVIA LEAF (UNII: 6TC6NN0876)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor	CHOCOLATE (Pistachio Chocolate Flavor)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83729-119-10	1 in 1 CARTON	07/17/2025
1		96 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	07/17/2025

Labeler - SuperMouth, LLC. (049384038)

Registrant - SuperMouth, LLC. (049384038)