Label: ORABALANCE DENTALCARE- 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 July 13, 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 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

  • INGREDIENTS AND APPEARANCE
    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)
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