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| Product NDC Code | 61596-880 | ||||
|---|---|---|---|---|---|
| Drug Name | Mipaste plus |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 1235783 | ||||
| Application Number | M021 | ||||
| Labeler Name | GC America Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Sodium Fluoride 0.2% (w/w)............Anticavity
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions * Adults and children over 12: brush teeth with your normal toothpaste at least twice a day, or as directed by your dental profession 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 mintues. Do not rinse. * Children under the age of 12: consult your dental professional or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Recommended Indications To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment. Secondarily, MI Paste Plus can be used for the management of tooth sensitivity, post-scaling, root planing and bleaching.
Purpose
Information about the drug product’s indications for use.Use Aids in the prevention of dental cavities
Spl product data elements
Usually a list of ingredients in a drug product.MIPaste Plus Strawberry sodium fluoride CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM SORBITOL WATER GLYCERIN PROPYLPARABEN PHOSPHORIC ACID SACCHARIN SODIUM TITANIUM DIOXIDE ETHYLPARABEN CALCIUM PHOSPHATE PROPYLENE GLYCOL XYLITOL BUTYLPARABEN SILICON DIOXIDE SODIUM FLUORIDE FLUORIDE ION MIPaste Plus sodium fluoride XYLITOL PROPYLENE GLYCOL CARBOXYMETHYLCELLULOSE SODIUM SORBITOL WATER GLYCERIN PROPYLPARABEN PHOSPHORIC ACID SACCHARIN SODIUM TITANIUM DIOXIDE ETHYLPARABEN CALCIUM PHOSPHATE BUTYLPARABEN SILICON DIOXIDE SODIUM FLUORIDE FLUORIDE ION MIPaste Plus sodium fluoride PROPYLPARABEN WATER BUTYLPARABEN SORBITOL GLYCERIN CALCIUM PHOSPHATE CARBOXYMETHYLCELLULOSE SODIUM PROPYLENE GLYCOL SILICON DIOXIDE TITANIUM DIOXIDE XYLITOL PHOSPHORIC ACID SACCHARIN SODIUM ETHYLPARABEN SODIUM FLUORIDE FLUORIDE ION MIPaste Plus sodium fluoride SORBITOL WATER GLYCERIN PHOSPHORIC ACID BUTYLPARABEN SILICON DIOXIDE SACCHARIN SODIUM TITANIUM DIOXIDE ETHYLPARABEN CALCIUM PHOSPHATE PROPYLENE GLYCOL XYLITOL CARBOXYMETHYLCELLULOSE SODIUM PROPYLPARABEN SODIUM FLUORIDE FLUORIDE ION MIPaste Plus sodium fluoride SORBITOL WATER GLYCERIN PROPYLPARABEN PHOSPHORIC ACID SACCHARIN SODIUM TITANIUM DIOXIDE ETHYLPARABEN CALCIUM PHOSPHATE PROPYLENE GLYCOL XYLITOL BUTYLPARABEN SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM SODIUM FLUORIDE FLUORIDE ION
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Tube Box Strawberry outer box
Tube Box Mint Outer box
Tube Box Vanilla outer box
Tube Box Melon outer box
Tube box Tutti-Frutti outer box
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Warnings Keep out of reach of children under 6 years of age.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information For additional application instructions, refer to the product insert.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-323-7063
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API