Mipasteone Kids Blue Raspberry

Mipasteone Kids Blue Raspberry
SPL v6
SPL
SPL Set ID bf7d668c-752a-2eee-e053-2a95a90add16
Route
DENTAL
Published
Effective Date 2021-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.24 g)
Inactive Ingredients
Water Phosphoric Acid Saccharin Sodium Xylitol Titanium Dioxide Glycerol Formal Silicon Dioxide Sodium Lauroyl Sarcosinate Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-09

Description

For adults and children 2 years of age or older, apply a small, pea-size amount of MI Paste ONE Kids to your toothbrush. For best results, brush for 2 minutes, expectorate and avoid eating or drinking for 30 minutes after brushing. Use twice daily. Replace cap after use. For children under 2 years of age, consult a dentist or physician.


Medication Information

Warnings and Precautions

Warning Keep out of reach of

children under 6 years of age. If more

than the recommended amount of

paste used for brushing is

accidentally swallowed, get medical

help or contact a Poison Control

Center right away. 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.

Indications and Usage

Use

- aids in the prevention of dental

cavities

Dosage and Administration

For adults and children 2

years of age or older, apply a small,

pea-size amount of MI Paste ONE

Kids to your toothbrush. For best

results, brush for 2 minutes,

expectorate and avoid eating or

drinking for 30 minutes after brushing.

Use twice daily. Replace cap after

use. For children under 2 years of age,

consult a dentist or physician.

Description

For adults and children 2 years of age or older, apply a small, pea-size amount of MI Paste ONE Kids to your toothbrush. For best results, brush for 2 minutes, expectorate and avoid eating or drinking for 30 minutes after brushing. Use twice daily. Replace cap after use. For children under 2 years of age, consult a dentist or physician.

Section 50565-1

Warning Keep out of reach of

children under 6 years of age. If more

than the recommended amount of

paste used for brushing is

accidentally swallowed, get medical

help or contact a Poison Control

Center right away. 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.

Section 50567-7

Section 51727-6

Inactive ingredients Pure water,

Glycerol, RECALDENT CPP-ACP

Casein Phosphopeptide-Amorphous

Calcium Phosphate, Sorbitol,

CMC-Na, Propylene glycol, Silicon

dioxide, Titanium dioxide, Xylitol,

Phosphoric acid, Flavoring, Sodium

saccharin, Ethyl p-hydroxybenzoate,

Propyl p-hydroxybenzoate, Butyl

p-hydroxybenzoate, Sodium-N-lauroyl

sarcosinate.

Section 51945-4

Section 55105-1

Use

- aids in the prevention of dental

cavities

Section 55106-9

Active ingredient Sodium Fluoride 0.24% w/w

Purpose Anti-cavity


Structured Label Content

Indications and Usage (34067-9)

Use

- aids in the prevention of dental

cavities

Dosage and Administration (34068-7)

For adults and children 2

years of age or older, apply a small,

pea-size amount of MI Paste ONE

Kids to your toothbrush. For best

results, brush for 2 minutes,

expectorate and avoid eating or

drinking for 30 minutes after brushing.

Use twice daily. Replace cap after

use. For children under 2 years of age,

consult a dentist or physician.

Warnings and Precautions (34071-1)

Warning Keep out of reach of

children under 6 years of age. If more

than the recommended amount of

paste used for brushing is

accidentally swallowed, get medical

help or contact a Poison Control

Center right away. 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.

Section 50565-1 (50565-1)

Warning Keep out of reach of

children under 6 years of age. If more

than the recommended amount of

paste used for brushing is

accidentally swallowed, get medical

help or contact a Poison Control

Center right away. 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.

Section 50567-7 (50567-7)

Section 51727-6 (51727-6)

Inactive ingredients Pure water,

Glycerol, RECALDENT CPP-ACP

Casein Phosphopeptide-Amorphous

Calcium Phosphate, Sorbitol,

CMC-Na, Propylene glycol, Silicon

dioxide, Titanium dioxide, Xylitol,

Phosphoric acid, Flavoring, Sodium

saccharin, Ethyl p-hydroxybenzoate,

Propyl p-hydroxybenzoate, Butyl

p-hydroxybenzoate, Sodium-N-lauroyl

sarcosinate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Use

- aids in the prevention of dental

cavities

Section 55106-9 (55106-9)

Active ingredient Sodium Fluoride 0.24% w/w

Purpose Anti-cavity


Advanced Ingredient Data


Raw Label Data

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