Otc - Active Ingredient
Active Ingredient
Sodium fluoride 0.20% (w/w)
Mipaste Plus Melon Paste, Dentifrice
FDA Label NDC 61596-804
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 Melon (NDC 61596-804). 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, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, 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
Otc - Purpose
Purpose
Anticavity
Indications & Usage
Use
• 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.
Otc - Keep Out Of Reach Of Children
Warnings
Keep out of reach of children under 6 years of age.
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
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