Oral BioTech
Oral BioTech
CariFree® CTx3 Rinse.05% w/v sodium fluoride
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
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:
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CTx3 Rinse
Anticaries RINSE
Product Information
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:61578-301 |
Route of Administration
|
DENTAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
Ingredient Name
|
Basis of Strength
|
Strength
|
SODIUM FLUORIDE FLUORIDE ION |
|
226 ug
|
Product Characteristics
|
Color
|
white (opaque) |
|
|
Packaging
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
1 |
NDC:61578-301-01 |
473 in 1 BOTTLE, PLASTIC |
|
|
2 |
NDC:61578-301-02 |
59 in 1 BOTTLE, PLASTIC |
|
|
Marketing Information
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
part |
part355 |
2012-05-01 |
|
|
CTx3 Rinse
Anticaries RINSE
Product Information
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:61578-303 |
Route of Administration
|
DENTAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
Ingredient Name
|
Basis of Strength
|
Strength
|
SODIUM FLUORIDE FLUORIDE ION |
|
226 ug
|
Product Characteristics
|
Color
|
white (opaque) |
|
|
Packaging
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
1 |
NDC:61578-303-01 |
473 in 1 BOTTLE, PLASTIC |
|
|
2 |
NDC:61578-303-02 |
59 in 1 BOTTLE, PLASTIC |
|
|
Marketing Information
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
part |
part355 |
2012-05-01 |
|
|
CTx3 Rinse
Anticaries RINSE
Product Information
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:61578-302 |
Route of Administration
|
DENTAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
Ingredient Name
|
Basis of Strength
|
Strength
|
SODIUM FLUORIDE FLUORIDE ION |
|
226 ug
|
Product Characteristics
|
Color
|
white (opaque) |
|
|
Packaging
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
1 |
NDC:61578-302-01 |
473 in 1 BOTTLE, PLASTIC |
|
|
Marketing Information
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
part |
part355 |
2012-05-01 |
|
|