Otc - Active Ingredient
Active Ingredient
Sodium fluoride 0.20% (w/w)
Mipaste Plus Strawberry Paste, Dentifrice
FDA Label NDC 61596-800
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gc America Inc. for the product Mipaste Plus Strawberry (NDC 61596-800). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, dosage & administration, inactive ingredient, otc - keep out of reach of children, otc - purpose, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
aids in the prevention of dental cavities
Warnings
Warnings
Keep out of reach of children under 6 years of age. 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
Dosage & Administration
Directions
• adults and children over 12:
brush teeth with your normal
toothpaste at least twice a day, or
as directed by your dental
professional 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
minutes. Do not rinse.
• children under the age of 12:
consult your dental professional or
doctor
Inactive Ingredient
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
under 6 years of age.
Otc - Purpose
Purpose
Anticavity
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