Premier Value Cavity Protection Mint

Dosage form: paste
Ingredients: SODIUM MONOFLUOROPHOSPHATE 7.6mg in 1g
Labeler: Premier Value
NDC Code: 68016-005

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.

Premier Value Cavity Protection Mint toothpaste

Active Ingredient

Sodium MonoFluoroPhosphate 0.76% (0.015% w/v fluoride ion)           ...Anticavity Toothpaste



USE

Helps protect against cavities.

As with all fluoride toothpastes, keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Directions

Adults and children        Brush teeth thoroughly, preferably
2 years and older           after each meal, or at least twice a day, or as
                                    directed by your dentist. Do not swallow.

Children under                To minimize swallowing, use a pea-sized
6 years of age                amount and supervise brushing until
                                     good habits are established.

Children under 2 years     Ask a dentist or physician.

Principal Display Panel

Inactive IngredientsSorbitol,Hydrated Silica,Water,Calcium Carbonate,Glycerine,Sodium Lauryl Sulphate,Cellulose Gum,Flavor,Sodium Benzoate,Sodium Saccharin, Sodium Phosphate,Titanium Dioxide,FDC BLUE NO. 1
PREMIER VALUE CAVITY PROTECTION MINT 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-005
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (Fluoride Ion) SODIUM MONOFLUOROPHOSPHATE7.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
HYDRATED SILICA 
WATER 
CALCIUM CARBONATE 
GLYCERIN 
SODIUM LAURYL SULFATE 
CARBOXYMETHYLCELLULOSE SODIUM 
SACCHARIN SODIUM 
SODIUM PHOSPHATE 
TITANIUM DIOXIDE 
FD&C BLUE NO. 1 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINT (Mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-005-0121 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/08/2003
Labeler - Premier Value (101668460)

Revised: 01/2011
 
Premier Value

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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