Mipaste Plus Melon

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.2 g)

Inactive Ingredients

Butylparaben Calcium Phosphate, Unspecified Form Glycerin Phosphoric Acid Carboxymethylcellulose Sodium, Unspecified Titanium Dioxide Propylene Glycol Water Xylitol Saccharin Sodium Sorbitol Ethylparaben Propylparaben Silicon Dioxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-02-03

Medication Information

Warnings and Precautions

Warnings

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

Do not use on patients with a milk protein or

hydroxybenzoates allergy. In case of allergic reaction; stop use, rinse mouth with water and seek medical advice. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.

Indications and Usage

Use

• aids in the prevention

of dental cavities

Dosage and Administration

Directions

• adults and children over 12:

brush teeth with your normal

toothpaste at least twice a day, or

as directed by your dental

professional or doctor, rinse

mouth after brushing, dispense a

pea-sized portion of MI Paste Plus

onto your finger, apply thoroughly,

coating the upper teeth with an

even layer, repeat for lower teeth,

allow to remain on teeth for 3

minutes. Do not rinse.

• children under the age of 12:

consult your dental professional or

doctor

Description

Active Ingredient Sodium fluoride 0.20% (w/w)

Section 50565-1

Warnings

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

Section 51727-6

Inactive ingredients

Butyl p-hydroxybenzoate, Casein

phosphopeptides and amorphous calcium

phosphate, D-sorbitol, Ethyl p-hydroxybenzoate,

Flavoring, Glycerol, Phosphoric acid, Propyl

p-hydroxybenzoate, Propylene glycol, Silicon

dioxide, Sodium carboxymethyl cellulose, Sodium

saccharin, Titanium dioxide, Water, Xylitol

Section 51945-4

Section 55105-1

Purpose

Anticavity

Section 55106-9

Active Ingredient

Sodium fluoride 0.20% (w/w)

Structured Label Content

Indications and Usage (34067-9)

Use

• aids in the prevention

of dental cavities

Dosage and Administration (34068-7)

Directions

• adults and children over 12:

brush teeth with your normal

toothpaste at least twice a day, or

as directed by your dental

professional or doctor, rinse

mouth after brushing, dispense a

pea-sized portion of MI Paste Plus

onto your finger, apply thoroughly,

coating the upper teeth with an

even layer, repeat for lower teeth,

allow to remain on teeth for 3

minutes. Do not rinse.

• children under the age of 12:

consult your dental professional or

doctor

Warnings and Precautions (34071-1)

Warnings

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

Do not use on patients with a milk protein or

hydroxybenzoates allergy. In case of allergic reaction; stop use, rinse mouth with water and seek medical advice. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Warnings

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

Section 51727-6 (51727-6)

Inactive ingredients

Butyl p-hydroxybenzoate, Casein

phosphopeptides and amorphous calcium

phosphate, D-sorbitol, Ethyl p-hydroxybenzoate,

Flavoring, Glycerol, Phosphoric acid, Propyl

p-hydroxybenzoate, Propylene glycol, Silicon

dioxide, Sodium carboxymethyl cellulose, Sodium

saccharin, Titanium dioxide, Water, Xylitol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Anticavity

Section 55106-9 (55106-9)

Active Ingredient

Sodium fluoride 0.20% (w/w)

Advanced Ingredient Data

[{"name": "BUTYLPARABEN", "unii": "3QPI1U3FV8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM PHOSPHATE, UNSPECIFIED FORM", "unii": "97Z1WI3NDX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHOSPHORIC ACID", "unii": "E4GA8884NN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLPARABEN", "unii": "14255EXE39", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Use • aids in the prevention of dental cavities", "34068-7": "Directions • adults and children over 12: brush teeth with your normal toothpaste at least twice a day, or as directed by your dental professional or doctor, rinse mouth after brushing, dispense a pea-sized portion of MI Paste Plus onto your finger, apply thoroughly, coating the upper teeth with an even layer, repeat for lower teeth, allow to remain on teeth for 3 minutes. Do not rinse. • children under the age of 12: consult your dental professional or doctor", "34071-1": "Warnings Keep out of reach of children under 6 years of age. Do not use on patients with a milk protein or hydroxybenzoates allergy. In case of allergic reaction; stop use, rinse mouth with water and seek medical advice. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.", "50565-1": "Warnings Keep out of reach of children under 6 years of age.", "51727-6": "Inactive ingredients Butyl p-hydroxybenzoate, Casein phosphopeptides and amorphous calcium phosphate, D-sorbitol, Ethyl p-hydroxybenzoate, Flavoring, Glycerol, Phosphoric acid, Propyl p-hydroxybenzoate, Propylene glycol, Silicon dioxide, Sodium carboxymethyl cellulose, Sodium saccharin, Titanium dioxide, Water, Xylitol", "55105-1": "Purpose Anticavity", "55106-9": "Active Ingredient Sodium fluoride 0.20% (w/w)"}