Ortho Super Mint Fluoride Mouthwash

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.002 mg)

Inactive Ingredients

Water Erythritol Xylitol Tribasic Calcium Phosphate Menaquinone 7 Cholecalciferol Inulin Glycerin Sodium Gluconate Sodium Bicarbonate Dimethyl Sulfone Benzoic Acid Sodium Ascorbate Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-02-21

Medication Information

Warnings and Precautions

WARNINGS:

Indications and Usage

USE

Fluoride mouthwash

Dosage and 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.

Description

ACTIVE INGREDIENT (in each 10 mL) Sodium Fluoride 0.02%

Section 50565-1

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

Section 51727-6

INACTIVE INGREDIENTS

Water, Erythritol, Xylitol, *Hydroxamin®

(Nano-Hydroxyapatite, Menaquinone-7

(Vit K2), Cholecalciferol (Vit D3)), Inulin,

Glycerin, Sodium Gluconate, Natural

Flavors, Sodium Bicarbonate, Methyl

-sulfonylmethane, Natural Benzoic Acid,

Sodium Ascorbate (Vit C), Xanthan Gum.

Section 55105-1

PURPOSE

Sodium Fluoride …. Anticavity

Section 55106-9

ACTIVE INGREDIENT

(in each 10 mL)

Sodium Fluoride 0.02%

Section 60561-8

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.

Product Labeling: Ortho Super Mint Fluoride Mouthwash

Supermouth

super mint

fluoride mouthwash

unique formulation for orthodontics that

reaches areas brushing & flossing don’t

16 fl oz (473 mL)

SuperMouth^®

9737 Aero Drive

San Diego, CA 92123

(844) MOUTHCARE

res

Structured Label Content

Indications and Usage (34067-9)

USE

Fluoride mouthwash

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

WARNINGS:

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS

Water, Erythritol, Xylitol, *Hydroxamin®

(Nano-Hydroxyapatite, Menaquinone-7

(Vit K2), Cholecalciferol (Vit D3)), Inulin,

Glycerin, Sodium Gluconate, Natural

Flavors, Sodium Bicarbonate, Methyl

-sulfonylmethane, Natural Benzoic Acid,

Sodium Ascorbate (Vit C), Xanthan Gum.

Section 55105-1 (55105-1)

PURPOSE

Sodium Fluoride …. Anticavity

Section 55106-9 (55106-9)

ACTIVE INGREDIENT

(in each 10 mL)

Sodium Fluoride 0.02%

Section 60561-8 (60561-8)

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.

Product Labeling: Ortho Super Mint Fluoride Mouthwash

Supermouth

super mint

fluoride mouthwash

unique formulation for orthodontics that

reaches areas brushing & flossing don’t

16 fl oz (473 mL)

SuperMouth^®

9737 Aero Drive

San Diego, CA 92123

(844) MOUTHCARE

res

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "USE Fluoride mouthwash", "34068-7": "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.", "34071-1": "WARNINGS:", "50565-1": "Keep out of reach of children under 6 years of age.", "51727-6": "INACTIVE INGREDIENTS Water, Erythritol, Xylitol, *Hydroxamin® (Nano-Hydroxyapatite, Menaquinone-7 (Vit K2), Cholecalciferol (Vit D3)), Inulin, Glycerin, Sodium Gluconate, Natural Flavors, Sodium Bicarbonate, Methyl -sulfonylmethane, Natural Benzoic Acid, Sodium Ascorbate (Vit C), Xanthan Gum.", "55105-1": "PURPOSE Sodium Fluoride …. Anticavity", "55106-9": "ACTIVE INGREDIENT (in each 10 mL) Sodium Fluoride 0.02%", "60561-8": "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.", "Product Labeling: Ortho Super Mint Fluoride Mouthwash": "Supermouth super mint fluoride mouthwash unique formulation for orthodontics that reaches areas brushing & flossing don’t 16 fl oz (473 mL) SuperMouth ® 9737 Aero Drive San Diego, CA 92123 (844) MOUTHCARE res"}

Ortho Super Mint Fluoride Mouthwash

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information