Active Ingredients
Lactobacillus gasseri HHuMin
Lactobacillus fermentum OK
Orabalance Dentalcare
FDA Label NDC 82690-401
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Isamogu Inc. for the product Orabalance Dentalcare (NDC 82690-401). 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 active ingredients, purpose, use, warnings, directions, inactive ingredients, package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Eliminate Bad Breath
Use
Improve oral health care
Warnings
do not eat silica gel
be careful, as you may get hurt when opening it.
Stop use and ask a doctor if irritation or rash appears and lasts.
avoid direct sunlight and store it in a dry, ventilated, cool place.
Keep out of reach of children
Directions
Melt one tablet slowly in your mouth and eat once
Inactive Ingredients
Oligosaccharide 3(Palatinos, Maltitol Syrup, Galacto-oligosaccharide)
xylitol
isomalt
maltodextrin
grape flavor powder
vitamin C
Magnesium Stearate
Calcium Pantothenate
silicon dioxide
vitamin E
vitamin K2
collagen
Package Label
82690-401
OraBalance Dentalcare
Label (Dentalcare)
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