Mipaste One Kids Bubble Gum

Mipaste One Kids Bubble Gum
SPL v3
SPL
SPL Set ID c07c7853-763b-4383-e053-2995a90ab725
Route
DENTAL
Published
Effective Date 2021-04-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.24 g)
Inactive Ingredients
Water Silicon Dioxide Butylparaben Sorbitol Propylene Glycol Phosphoric Acid Propylparaben Glycerin Carboxymethylcellulose Sodium, Unspecified Titanium Dioxide Ethylparaben Xylitol Sodium Lauroyl Sarcosinate Saccharin Sodium Calcium Phosphate, Unspecified Form

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-21

Description

Active ingredient Sodium Fluoride 0.24% w/w


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

Anti-cavity toothpaste with bio-available

calcium, phosphate and Fluoride

Dosage and Administration

Directions 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

Active ingredient Sodium Fluoride 0.24% w/w

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 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

Anti-cavity

Section 55106-9

Active ingredient

Sodium Fluoride

0.24% w/w

Section 60560-0


Structured Label Content

Indications and Usage (34067-9)

Use

- aids in the prevention of dental

cavities

Anti-cavity toothpaste with bio-available

calcium, phosphate and Fluoride

Dosage and Administration (34068-7)

Directions 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 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)

Anti-cavity

Section 55106-9 (55106-9)

Active ingredient

Sodium Fluoride

0.24% w/w

Section 60560-0 (60560-0)


Advanced Ingredient Data


Raw Label Data

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