CTX4 RINSE MINT- anticaries rinse CTX4 RINSE APPLE- anticaries rinse

CTx4 Rinse by

Drug Labeling and Warnings

CTx4 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% 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:

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INGREDIENTS AND APPEARANCE

CTX4 RINSE  MINT
anticaries rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61578-304
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)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61578-304-01	2 in 1 PACKAGE
1		118 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

CTX4 RINSE  APPLE
anticaries rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61578-305
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
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)

Product Characteristics
Color	white (hazy)	Score
Shape		Size
Flavor	APPLE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61578-305-01	2 in 1 PACKAGE
1		118 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(61578-304, 61578-305) , label(61578-304, 61578-305) , pack(61578-304, 61578-305)