Opalescence PF

Dosage form: paste, dentifrice
Ingredients: Sodium Fluoride 0.070875g in 28.35g, Potassium Nitrate 1.4175g in 28.35g
Labeler: Ultradent Products, Inc.
NDC Code: 51206-303

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.

Opalescence® PF
whitening toothpaste

Drug Facts

Active ingredient/Purpose

Sodium Fluoride 0. 25%w/w (Anticavity)
Potassium Nitrate 5%w/w

Uses

Anti hypersensitivity

Warning

Keep out of reach of children under 6 years of age.

  • If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.

  • Stop use and ask a dentist if the problem persists or worsens.

  • Sensitive teeth may indicate a problem needing prompt care by a dentist.

  • Do not use product longer than 4 weeks unless recommended by a dentist or doctor.

Directions
  • Adults and children 12 years of age and older:
  • Apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
  • Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitvie areas of the teeth.
  • Children under 12 years of age: consult a dentist or physician.

Inactive Ingredients

Water (aqua), Silica, Xylitol, Glycerin, Sorbitol, Poloxamer, Carbomer, Cocamidopropyl Amino Betaine, Flavor (aroma), Sodium Benzoate, Sodium Hydroxide, Sodium Saccharin, Sparkle (CI 77019, CI 77891), Titanium Dioxide (CI 77891), Xanthan Gum

PRINCIPAL DISPLAY PANEL - 28.35g carton

For sensitive teeth

Opalescence® PF
whitening toothpaste

Vanilla Mint with
Potassium Nitrate
and Fluoride

NET WT. 1.0 oz • 28.35g

OPALESCENCE PF 
sodium fluoride and potassium nitrate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51206-303
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Sodium Fluoride0.070875 g  in 28.35 g
Potassium Nitrate (Potassium Cation) Potassium Nitrate1.4175 g  in 28.35 g
Inactive Ingredients
Ingredient NameStrength
water 
xylitol 
Silicon Dioxide 
Glycerin 
Sodium Benzoate 
Titanium Dioxide 
Sodium Hydroxide 
Xanthan Gum 
Sodium Lauryl Sulfate 
Sorbitol 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINT (Vanilla Mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51206-303-071 TUBE (TUBE) in 1 BOX
128.35 g in 1 TUBE
2NDC:51206-303-061 TUBE (TUBE) in 1 BOX
2133 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/15/2010
Labeler - Ultradent Products, Inc. (013369916)
Establishment
NameAddressID/FEIOperations
Ultradent Products, Inc.013369916MANUFACTURE

Revised: 12/2010
 
Ultradent Products, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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