CTX3 RINSE MINT- anticaries rinse 
CTX3 RINSE GRAPE- anticaries rinse 
CTX3 RINSE CITRUS- anticaries rinse 
Dental Alliance Holdings LLC

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.

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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

CTx3R Mint, Citrus, and Grape enclosure labels:

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

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)

Revised: 12/2022
Document Id: f127e236-5205-948b-e053-2a95a90ab740
Set id: aa61834a-ff12-4c31-828f-43b1292fef3d
Version: 3
Effective Time: 20221231
 
Dental Alliance Holdings LLC