ORABALANCE BREATHCARE- 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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82690-402
OraBalance Breathcare

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 at once

Inactive Ingredients

Isomalt, Oligosaccharide 3(Palatinos, Maltitol Syrup, Galacto-oligosaccharide), Xylitol, Maltodextrin, Spearmint extract, Magnesium Stearate, Bifidobacterium bifidum BGN4, Bifidobacterium animalis ssp. lactis AD011, Bifidobacterium longum BORI, vitamin C, Nicotinamide, Calcium Pantothenate, vitamin B2, Vitamin B1 Hydrochloride, Vitamin B6 Hydrochloride, Gum arabic, Saccharose, Corn Starch, Processed Fat, Silicon Dioxide, Vitamin D3, Vitamin E, Dextrin, Sodium Citrate, Citric Acid, VitaminB12

label

82690-402

OraBalance Breathcare label

ORABALANCE BREATHCARE 
lactobacillus gasseri hhumin, lactobacillus fermentum ok tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82690-402
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LACTOBACILLUS GASSERI (UNII: Q66E0D2443) (LACTOBACILLUS GASSERI - UNII:Q66E0D2443) LACTOBACILLUS GASSERI56 mg  in 100 g
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) (LIMOSILACTOBACILLUS FERMENTUM - UNII:2C1F12C6AP) LIMOSILACTOBACILLUS FERMENTUM24 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
RIBOFLAVIN (UNII: TLM2976OFR)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
THIAMINE HYDROCHLORIDE (UNII: M572600E5P)  
ACACIA (UNII: 5C5403N26O)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ISOMALTULOSE ANHYDROUS (UNII: V59P50X4UY)  
MALTITOL (UNII: D65DG142WK)  
SUCROSE (UNII: C151H8M554)  
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
BIFIDOBACTERIUM BIFIDUM BGN4 (UNII: YHK9HJP3KK)  
4'-GALACTOSYLLACTOSE (UNII: B8CW1B3F6R)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SPEARMINT (UNII: J7I2T6IV1N)  
BIFIDOBACTERIUM LONGUM (UNII: 831AQW699W)  
NIACINAMIDE (UNII: 25X51I8RD4)  
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
CYANOCOBALAMIN (UNII: P6YC3EG204)  
BIFIDOBACTERIUM ANIMALIS LACTIS (UNII: 5307V7XW8I)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
ISOMALT (UNII: S870P55O2W)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize13mm
FlavorSPEARMINTImprint Code blank
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82690-402-0124 g in 1 BOX; Type 0: Not a Combination Product08/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/02/2022
Labeler - isamogu Inc. (695695834)
Registrant - isamogu Inc. (695695834)
Establishment
NameAddressID/FEIBusiness Operations
isamogu Inc.695695834manufacture(82690-402)

Revised: 8/2022
Document Id: e53ee262-5fe9-ed0c-e053-2995a90a8ece
Set id: e53ee262-5fe8-ed0c-e053-2995a90a8ece
Version: 1
Effective Time: 20220802
 
isamogu Inc.