Label: TREATMENT RINSE APPLE- anticaries rinse
TREATMENT RINSE MINT- anticaries rinse

  • NDC Code(s): 61578-314-01, 61578-315-01
  • 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% when mixed with part B

  • 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:

    Do not use before mixing with Part B. Adults and children 6 years of age and older: Use once daily after brushing. Shake each bottle before use. Using the measuring cup, combine 5 mL of component A with 5 mL of component B (10 mL, total). Vigorously swish the combined 10 mL 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. Do not dilute. Do not use either component alone. Store below 30 degrees C (86 degrees F). Do not freeze.

  • Inactive ingredients:

    Menthol, Natural Flavors, Polysorbate 20, Sodium Benzoate, Sodium Hydroxide, Sodium Hypochlorite, Water, Xylitol.

  • Treatment Rinse Mint and Apple enclosure and carton labels:

    Box Principle Display PanelBox Principle Display PanelBottle Principle Display PanelBottle Principle Display PanelBottle Principle Display Panel

  • INGREDIENTS AND APPEARANCE
    TREATMENT RINSE  APPLE
    anticaries rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61578-315
    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
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    Product Characteristics
    Colorwhite (hazy) Score    
    ShapeSize
    FlavorAPPLEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61578-315-012 in 1 PACKAGE05/10/2022
    1175.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02105/10/2022
    TREATMENT RINSE  MINT
    anticaries rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61578-314
    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)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    Product Characteristics
    Colorwhite (hazy) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61578-314-012 in 1 PACKAGE05/10/2022
    1175.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    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(61578-314, 61578-315)
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