Mipaste Plus Strawberry (2)

Mipaste Plus Strawberry (2)
SPL v3
SPL
SPL Set ID d7235ad7-83d7-12e5-e053-2a95a90aaeaf
Route
DENTAL
Published
Effective Date 2022-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 g)
Inactive Ingredients
Saccharin Sodium Carboxymethylcellulose Sodium, Unspecified Form Calcium Phosphate, Unspecified Form Sorbitol Ethylparaben Phosphoric Acid Propylene Glycol Titanium Dioxide Silicon Dioxide Xylitol Water Butylparaben Glycerin Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-03

Description

Active Ingredient Sodium fluoride 0.20% (w/w)


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

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

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)

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)

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


Raw Label Data

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