Label: MAINTENANCE RINSE GRAPE- anticaries rinse
MAINTENANCE RINSE MINT- anticaries rinse
MAINTENANCE RINSE CITRUS- anticaries rinse

  • NDC Code(s): 61578-311-01, 61578-311-02, 61578-312-01, 61578-313-01
  • Packager: Dental Alliance Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 31, 2024

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  • Active ingredients:

    Sodium Fluoride 0.05%

  • Purpose:

    Anticavity

  • Use:

    Aids in the prevention of dental caries (cavities)

  • Warnings:

    Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. If you experience any unusual symptoms, stop use and contact your dentist.

  • Warnings:

    Keep out of reach of children.

  • Directions:

    Adults and children 6 years of age and older: Use once daily after brushing your teeth with toothpaste. Vigorously swish 10mL of rinse between teeth for one minute, then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or physician. Store below 30 degrees C (86 degrees F). Do not freeze.

  • Inactive ingredients:

    Menthol (Mint only), Natural Flavors (Mint only), Natural and Artificial Flavors (Citrus and Grape only), Polysorbate 20, Potassium Sorbate, Sodium Benzoate, Sodium Bicarbonate, Water, Xylitol

  • Maintenance Mint, Citrus, and Grape enclosure labels:

    Bottle Principle Display PanelBottle Principle Display PanelBottle Principle Display PanelBottle Principle Display Panel

  • INGREDIENTS AND APPEARANCE
    MAINTENANCE RINSE  GRAPE
    anticaries rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61578-313
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION226 ug  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Colorwhite (opaque) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61578-313-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02105/10/2022
    MAINTENANCE RINSE  MINT
    anticaries rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61578-311
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION226 ug  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MENTHOL (UNII: L7T10EIP3A)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Colorwhite (opaque) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61578-311-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/10/2022
    2NDC:61578-311-02100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02105/10/2022
    MAINTENANCE RINSE  CITRUS
    anticaries rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61578-312
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION226 ug  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Colorwhite (opaque) Score    
    ShapeSize
    FlavorCITRUSImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61578-312-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02105/10/2022
    Labeler - Dental Alliance Holdings LLC (195544965)
    Registrant - Dental Alliance Holdings LLC (195544965)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dental Alliance Holdings LLC195544965manufacture(61578-311, 61578-312, 61578-313)
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