ORABALANCE DENTALCARE- lactobacillus gasseri hhumin, lactobacillus fermentum ok tablet 
isamogu Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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82690-401
OraBalance Dentalcare

Active ingredients

Lactobacillus gasseri HHuMin

Lactobacillus fermentum OK

Purpose

Eliminate Bad Breath

use

Improve oral health care

Warnings

do not eat silica gel

Warnings

be careful, as you may get hurt when opening it.

Warnings

Stop use and ask a doctor if irritation or rash appears and lasts.

Warnings

avoid direct sunlight and store it in a dry, ventilated, cool place.

Warnings

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

ORABALANCE DENTALCARE 
lactobacillus gasseri hhumin, lactobacillus fermentum ok tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82690-401
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LACTOBACILLUS GASSERI (UNII: Q66E0D2443) (LACTOBACILLUS GASSERI - UNII:Q66E0D2443) LACTOBACILLUS GASSERI24 mg  in 100 g
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) (LIMOSILACTOBACILLUS FERMENTUM - UNII:2C1F12C6AP) LIMOSILACTOBACILLUS FERMENTUM72 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
MENAQUINONE 6 (UNII: 71ANL51TLA)  
COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)  
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
CITRUS PARADISI WHOLE (UNII: 3FNT9K2294)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
ISOMALTULOSE ANHYDROUS (UNII: V59P50X4UY)  
4'-GALACTOSYLLACTOSE (UNII: B8CW1B3F6R)  
MALTITOL (UNII: D65DG142WK)  
XYLITOL (UNII: VCQ006KQ1E)  
ISOMALT (UNII: S870P55O2W)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize13mm
FlavorSPEARMINTImprint Code blank
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82690-401-0124 g in 1 BOX; Type 0: Not a Combination Product07/13/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/13/2022
Labeler - isamogu Inc. (695695834)

Revised: 7/2022
Document Id: e3ab5461-bda6-e7f8-e053-2995a90a8211
Set id: e3ab5461-bda5-e7f8-e053-2995a90a8211
Version: 1
Effective Time: 20220713
 
isamogu Inc.