Label: CTX3 RINSE MINT- anticaries rinse
CTX3 RINSE GRAPE- anticaries rinse
CTX3 RINSE CITRUS- anticaries rinse

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 31, 2022

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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

  • CTx3R Mint, Citrus, and Grape enclosure labels:

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

  • INGREDIENTS AND APPEARANCE
    CTX3 RINSE  MINT
    anticaries rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61578-301
    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:61578-301-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/201209/30/2022
    2NDC:61578-301-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/201209/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35505/01/201209/30/2022
    CTX3 RINSE  GRAPE
    anticaries rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61578-303
    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:61578-303-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2012
    2NDC:61578-303-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/201211/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35505/01/2012
    CTX3 RINSE  CITRUS
    anticaries rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61578-302
    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:61578-302-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35505/01/2012
    Labeler - Dental Alliance Holdings LLC (195544965)
    Registrant - Dental Alliance Holdings LLC (195544965)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dental Alliance Holdings LLC195544965manufacture(61578-301, 61578-302, 61578-303)
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