SUPER CHOCOLATE FLUORIDE MOUTHWASH- anticavity mouthwash liquid

Super Chocolate Fluoride Mouthwash by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT
(in each 10 mL)

Sodium Fluoride 0.02%

PURPOSE

PURPOSE
Sodium Fluoride …. Anticavity

INDICATIONS & USAGE

USE

Fluoride mouthwash

WARNINGS

WARNINGS:

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

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

Do not use if safety seal
is broken.

DOSAGE & ADMINISTRATION

DIRECTIONS

1) Shake well before using.
2) Use daily by dispensing 10 mL, swish
    vigorously for 1 minute, and then spit out.
3) No need to rinse.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS

Water, Erythritol, Xylitol, *Hydroxamin®
(Nano-Hydroxyapatite, Menaquinone-7
(Vit K2), Cholecalciferol (Vit D3)), Inulin,
Glycerin, Sodium Gluconate, Sodium
Bicarbonate, Methylsulfonylmethane,
Natural Flavors, Natural Benzoic Acid,
Sodium Ascorbate (Vit C), Xanthan Gum.

Product Labeling: Super Chocolate Fluoride Mouthwash

Supermouth

super chocolate

fluoride mouthwash

16 fl oz (473 mL)

SuperMouth®
9737 Aero Drive
San Diego, CA 92123

(844) MOUTHCARE

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INGREDIENTS AND APPEARANCE

SUPER CHOCOLATE FLUORIDE MOUTHWASH 
anticavity mouthwash liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83729-107
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.002 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
MENAQUINONE 7 (UNII: 8427BML8NY)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
INULIN (UNII: JOS53KRJ01)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM GLUCONATE (UNII: R6Q3791S76)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM ASCORBATE (UNII: S033EH8359)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor	CHOCOLATE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83729-107-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/21/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	03/21/2023

Labeler - SuperMouth, LLC. (049384038)

Registrant - SuperMouth, LLC. (049384038)