PREMIER VALUE CAVITY PROTECTION MINT - sodium monofluorophosphate paste 
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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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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

image of container

Inactive Ingredients

Sorbitol,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 AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE7.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINT (Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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: 1/2011
Document Id: 5c169066-20ad-4b96-88f8-59da57e4684b
Set id: e165d6f3-5ba4-49ce-838f-36f00e63915c
Version: 1
Effective Time: 20110107
 
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