The following Structured Product Label (SPL) was submitted to the FDA by Gc America Inc. for the product Mipaste One Kids Cotton Candy (NDC 61596-102). 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 intended use of the device, dosage & administration, warnings, inactive ingredient, indications & usage, otc - keep out of reach of children, otc - purpose, otc - active ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Directions For adults and children 2
years of age or older, apply a small,
pea-size amount of MI Paste ONE
Kids to your toothbrush. For best
results, brush for 2 minutes,
expectorate and avoid eating or
drinking for 30 minutes after brushing.
Use twice daily. Replace cap after
use. For children under 2 years of age,
consult a dentist or physician.
Warning Keep out of reach of
children under 6 years of age. 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.
Inactive ingredients Pure water,
Glycerol, RECALDENT CPP-ACP
Casein Phosphopeptide-Amorphous
Calcium Phosphate, Sorbitol,
CMC-Na, Propylene glycol, Silicon
dioxide, Titanium dioxide, Xylitol,
Phosphoric acid, Flavoring, Sodium
saccharin, Ethyl p-hydroxybenzoate,
Propyl p-hydroxybenzoate, Butyl
p-hydroxybenzoate, Sodium-N-lauroyl
sarcosinate.
Use
- aids in the prevention of dental
cavities
Warning Keep out of reach of
children under 6 years of age. 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.
Purpose: Anticavity
Active ingredient
Sodium Fluoride
0.24% w/w
* Please review the disclaimer below.
