SUPER VANILLA- vanilla toothpaste paste, dentifrice

Super Vanilla by

Drug Labeling and Warnings

Super Vanilla by is a Otc medication manufactured, distributed, or labeled by SuperMouth, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

DRUG FACTS

ACTIVE INGREDIENT

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

PURPOSE

PURPOSE
Anticavity Toothpaste

INDICATIONS & USAGE

USE

Aids in the prevention of cavities

WARNINGS

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

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, Methylsulfonylmethane, Natural Flavor, 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 Vanilla Fluoride Toothpaste

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

Supermouth

super vanilla

fluoride toothpaste

safe effective fun

3.4 oz (96 g)

SuperMouth®

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

res

INGREDIENTS AND APPEARANCE

SUPER VANILLA 
vanilla toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83729-115
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
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)
QUILLAJA SAPONARIA WHOLE (UNII: HIU9R169Y7)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM ASCORBATE (UNII: S033EH8359)
STEVIA LEAF (UNII: 6TC6NN0876)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)

Product Characteristics
Color	gray	Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83729-115-10	1 in 1 CARTON	06/30/2027
1		96 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	06/30/2025

Labeler - SuperMouth, LLC. (049384038)

Registrant - SuperMouth, LLC. (049384038)