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CTx3 Rinse Mint

Medically reviewed on Dec 27, 2017

Dosage form: rinse
Ingredients: SODIUM FLUORIDE 226ug in 1mL
Labeler: Oral BioTech
NDC Code: 61578-301

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.

CariFree® CTx3 Rinse
.05% w/v sodium fluoride

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 473mL enclosure labels:

CTX3 RINSE  MINT
anticaries rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61578-301
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION226 ug  in 1 mL
Inactive Ingredients
Ingredient NameStrength
MENTHOL 
POLYSORBATE 20 
POTASSIUM SORBATE 
SODIUM BENZOATE 
SODIUM BICARBONATE 
WATER 
XYLITOL 
Product Characteristics
Colorwhite (opaque) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:61578-301-01473 mL in 1 BOTTLE, PLASTIC
2NDC:61578-301-0259 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/01/2012
CTX3 RINSE  GRAPE
anticaries rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61578-303
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION226 ug  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 20 
POTASSIUM SORBATE 
SODIUM BENZOATE 
SODIUM BICARBONATE 
WATER 
XYLITOL 
Product Characteristics
Colorwhite (opaque) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:61578-303-01473 mL in 1 BOTTLE, PLASTIC
2NDC:61578-303-0259 mL in 1 BOTTLE, PLASTIC
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 AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION226 ug  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 20 
POTASSIUM SORBATE 
SODIUM BENZOATE 
SODIUM BICARBONATE 
WATER 
XYLITOL 
Product Characteristics
Colorwhite (opaque) Score    
ShapeSize
FlavorCITRUSImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:61578-302-01473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/01/2012
Labeler - Oral BioTech (195544965)
Registrant - Oral BioTech (195544965)
Establishment
NameAddressID/FEIOperations
Oral BioTech195544965manufacture(61578-301, 61578-302, 61578-303), label(61578-301, 61578-302, 61578-303), pack(61578-301, 61578-302, 61578-303)

Document Id: 16ba2e79-b217-44b5-b228-76507e06eb12
Set id: aa61834a-ff12-4c31-828f-43b1292fef3d
Version: 1
Effective Time: 20131227
 
Oral BioTech

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