MAINTENANCE RINSE GRAPE- anticaries rinse 
MAINTENANCE RINSE MINT- anticaries rinse 
MAINTENANCE RINSE CITRUS- anticaries rinse 
Dental Alliance Holdings LLC

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Maintenance Rinse

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

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)

Revised: 1/2024
Document Id: 1046e99b-bf50-ae6f-e063-6294a90a11f6
Set id: f1273510-aa83-3ef9-e053-2a95a90aea27
Version: 2
Effective Time: 20240131
 
Dental Alliance Holdings LLC