CTX3 RINSE MINT- anticaries rinse CTX3 RINSE GRAPE- anticaries rinse CTX3 RINSE CITRUS- anticaries rinse

CTx3 Rinse by

Drug Labeling and Warnings

CTx3 Rinse by is a Otc medication manufactured, distributed, or labeled by Dental Alliance Holdings LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

-----------------------------------------------------------------------------------------------------------------------------------------------------

-----------------------------------------------------------------------------------------------------------------------------------------------------

INGREDIENTS AND APPEARANCE

CTX3 RINSE  MINT
anticaries rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61578-301
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	226 ug  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (opaque)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61578-301-01	473 mL in 1 BOTTLE, PLASTIC
2	NDC: 61578-301-02	59 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/01/2012

CTX3 RINSE  GRAPE
anticaries rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61578-303
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	226 ug  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	white (opaque)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61578-303-01	473 mL in 1 BOTTLE, PLASTIC
2	NDC: 61578-303-02	59 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/01/2012

CTX3 RINSE  CITRUS
anticaries rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61578-302
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	226 ug  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	white (opaque)	Score
Shape		Size
Flavor	CITRUS	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61578-302-01	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/01/2012

Labeler - Oral BioTech (195544965)

Registrant - Oral BioTech (195544965)

Establishment
Name	Address	ID/FEI	Business Operations
Oral BioTech		195544965	manufacture(61578-301, 61578-302, 61578-303) , label(61578-301, 61578-302, 61578-303) , pack(61578-301, 61578-302, 61578-303)