Label: ORABALANCE BREATHCARE- lactobacillus gasseri hhumin, lactobacillus fermentum ok tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated August 2, 2022

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  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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