FAMILY WELLNESS SENSITIVE EXTRA WHITENING- potassium nitrate and sodium fluoride paste 
Family Wellness

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.

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Family Wellness Sensitive Extra Whitening

Active Ingredients

Potassium nitrate 5%........................................... Antihypersensitivity

Sodium Fluoride 0.243% (0.15% w/v fluoride ion).... Anticavity toothpaste

USES


Purpose

Stop use and ask a dentist if

Keep out of reach of children

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years and older Brush teeth for at least one minute, preferably after each meal, or at least twice a day or as directed by your dentist. Be sure to brush sensitive areas of the teeth.
Children under 12 years of age Consult a dentist or doctor
Other information Store in a cool, dry place.

Inactive ingredients

sorbitol, water, silica, sodium lauryl sulfate, flavor, cellulose gum, titanium dioxide, sodium benzoate, sodium phosphate, tetrasodium pyrophosphate, sodium saccharin.

image description

FAMILY WELLNESS SENSITIVE EXTRA WHITENING 
potassium nitrate and sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-900
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
Colorwhite (Sensitive) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-900-01113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/11/2013
Labeler - Family Wellness (024472631)

Revised: 4/2013
Document Id: f06fee99-2d1b-4adf-a5a0-9e90db64a461
Set id: 22b5d423-b43a-4be9-be98-998640ff1c13
Version: 1
Effective Time: 20130411
 
Family Wellness