CTX4 RINSE MINT- anticaries rinse 
CTX4 RINSE APPLE- 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.

----------

Treatment Rinse

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.

CTx4 Rinse Mint and Apple enclosure and carton labels:

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

CTX4 RINSE  MINT
anticaries rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61578-304
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:61578-304-012 in 1 PACKAGE05/10/2022
1118 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 finalpart35505/01/201209/30/2022
CTX4 RINSE  APPLE
anticaries rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61578-305
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:61578-305-012 in 1 PACKAGE05/10/2022
1118 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 finalpart35505/01/201209/30/2022
Labeler - DENTAL ALLIANCE HOLDINGS LLC (195544965)
Registrant - DENTAL ALLIANCE HOLDINGS LLC (195544965)
Establishment
NameAddressID/FEIBusiness Operations
DENTAL ALLIANCE HOLDINGS LLC195544965manufacture(61578-304, 61578-305)

Revised: 12/2022
 
DENTAL ALLIANCE HOLDINGS LLC