Mipaste One

Mipaste One
SPL v3
SPL
SPL Set ID d71f8e6e-7005-4b3e-e053-2995a90a6789
Route
DENTAL
Published
Effective Date 2022-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (5 g) Fluoride Ion (0.24 g)
Inactive Ingredients
Calcium Phosphate, Unspecified Form Titanium Dioxide Methyl Salicylate Ethylparaben Water Sorbitol Carboxymethylcellulose Sodium, Unspecified Form Propylene Glycol Propylparaben Saccharin Sodium Xylitol Silicon Dioxide Glycerin Phosphoric Acid Butylparaben Sodium Lauroyl Sarcosinate

Identifiers & Packaging

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

Description

Sodium fluoride 0.24% w/w Potassium nitrate 5% (w/w)


Medication Information

Warnings and Precautions

Warning If the sensitivity persists after 4 weeks of use, consult a dentist or physician. Keep out of reach of children. 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

- aids in prevention of dental 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 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

Sodium fluoride 0.24% w/w Potassium nitrate 5% (w/w)

Section 50565-1

Warning Keep out of reach of children.

Section 51727-6

Inactive ingredient Pure water, Glycerol, RECALDENT (CPP-ACP), Casein Phosphopeptide-Amorphous, Calcium Phosphate, Sorbitol, CMC-NA, Propylene glycol, Silicon dioxide, Titanium dioxide, Xylitol, Phosphoric acid, flavoring, Methyl salicylate, Sodium saccharin, Ethyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Butyl p-hydroxybenzoate, Sodium-N-lauroyl sarcosinate

Section 51945-4

Section 55105-1

Anti-cavity

Anti-sensitivity

Section 55106-9

Sodium fluoride

0.24% w/w

Potassium nitrate

5% (w/w)


Structured Label Content

Indications and Usage (34067-9)

- aids in prevention of dental 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 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)

Warning If the sensitivity persists after 4 weeks of use, consult a dentist or physician. Keep out of reach of children. 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.

Section 51727-6 (51727-6)

Inactive ingredient Pure water, Glycerol, RECALDENT (CPP-ACP), Casein Phosphopeptide-Amorphous, Calcium Phosphate, Sorbitol, CMC-NA, Propylene glycol, Silicon dioxide, Titanium dioxide, Xylitol, Phosphoric acid, flavoring, Methyl salicylate, 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

Anti-sensitivity

Section 55106-9 (55106-9)

Sodium fluoride

0.24% w/w

Potassium nitrate

5% (w/w)


Advanced Ingredient Data


Raw Label Data

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