Mipaste One Perio

Mipaste One Perio
SPL v4
SPL
SPL Set ID d656b72d-48f8-4425-e053-2995a90ab1f2
Route
DENTAL
Published
Effective Date 2022-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.454 g)
Inactive Ingredients
Water Calcium Phosphate, Unspecified Form Carboxymethylcellulose Sodium, Unspecified Glycerin Silicon Dioxide Saccharin Sodium Ethylparaben Propylene Glycol Sorbitol Sodium Lauryl Sulfate Xylitol Propylparaben Butylparaben Sodium Citrate, Unspecified Form Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-01

Description

Active ingredient Stannous fluoride 0.454% w/w (0.13% w/v fluoride ion)


Medication Information

Warnings and Precautions

• Keep out of reach of children

• Stop use and ask a dentist if

gingivitis, bleeding, or redness

persists for more than 2 weeks, or

if you have painful or swollen

gums, pus from the gum line, loose

teeth, or increasing spacing

between the teeth. These may be

signs of periodontitis, a serious

form of gum disease.

• When using this product for

sensitivity, do not use longer than

4 weeks unless recommended by

a dentist.

• 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

Uses

• Helps prevent gingivitis

• Helps interfere with harmful

effects of plaque associated

with gingivitis

• Aids in the prevention of cavities

• Builds increasing protection

against painful sensitivity of the

teeth to cold, heat, acids, sweets,

or contact

Dosage and Administration

For adults and children 12

years of age or older, apply a

small, pea-size amount of MI Paste

ONE Perio to your toothbrush. For

best results, brush for 2 minutes,

expectorate and do not rinse; do

not eat or drink for 30 minutes after

brushing. Use twice daily. Replace

cap after use. For children under

12 years of age, consult a dentist

or physician.

Description

Active ingredient Stannous fluoride 0.454% w/w (0.13% w/v fluoride ion)

Section 50565-1

• Keep out of reach of children

Section 51727-6

Inactive ingredients

Water, Glycerol, Silicon dioxide,

RECALDENT® (CPP-ACP) Casein

Phosphopeptide-Amorphous

Calcium Phosphate, Sorbitol,

CMC-Na, Propylene glycol,

Sodium lauryl sulfate, Sodium

citrate, Flavoring, Titanium dioxide,

Xylitol, Sodium saccharin, Ethyl

p-hydroxybenzoate, Propyl

p-hydroxybenzoate,

Butyl p-hydroxybenzoate

Section 51945-4

Section 55105-1

Purposes

Anti-gingivitis

Anti-cavity

Anti-sensitivity

Section 55106-9

Active ingredient

Stannous fluoride

0.454% w/w

(0.13% w/v fluoride ion)

Section 60555-0


Structured Label Content

Indications and Usage (34067-9)

Uses

• Helps prevent gingivitis

• Helps interfere with harmful

effects of plaque associated

with gingivitis

• Aids in the prevention of cavities

• Builds increasing protection

against painful sensitivity of the

teeth to cold, heat, acids, sweets,

or contact

Dosage and Administration (34068-7)

For adults and children 12

years of age or older, apply a

small, pea-size amount of MI Paste

ONE Perio to your toothbrush. For

best results, brush for 2 minutes,

expectorate and do not rinse; do

not eat or drink for 30 minutes after

brushing. Use twice daily. Replace

cap after use. For children under

12 years of age, consult a dentist

or physician.

Warnings and Precautions (34071-1)

• Keep out of reach of children

• Stop use and ask a dentist if

gingivitis, bleeding, or redness

persists for more than 2 weeks, or

if you have painful or swollen

gums, pus from the gum line, loose

teeth, or increasing spacing

between the teeth. These may be

signs of periodontitis, a serious

form of gum disease.

• When using this product for

sensitivity, do not use longer than

4 weeks unless recommended by

a dentist.

• 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)

• Keep out of reach of children

Section 51727-6 (51727-6)

Inactive ingredients

Water, Glycerol, Silicon dioxide,

RECALDENT® (CPP-ACP) Casein

Phosphopeptide-Amorphous

Calcium Phosphate, Sorbitol,

CMC-Na, Propylene glycol,

Sodium lauryl sulfate, Sodium

citrate, Flavoring, Titanium dioxide,

Xylitol, Sodium saccharin, Ethyl

p-hydroxybenzoate, Propyl

p-hydroxybenzoate,

Butyl p-hydroxybenzoate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purposes

Anti-gingivitis

Anti-cavity

Anti-sensitivity

Section 55106-9 (55106-9)

Active ingredient

Stannous fluoride

0.454% w/w

(0.13% w/v fluoride ion)

Section 60555-0 (60555-0)


Advanced Ingredient Data


Raw Label Data

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