PREMIER VALUE CAVITY PROTECTION MINT- sodium monofluorophosphate paste

Premier Value Cavity Protection Mint by

Drug Labeling and Warnings

Premier Value Cavity Protection Mint by is a Otc medication manufactured, distributed, or labeled by Premier Value. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

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

PURPOSE

KEEP OUT OF REACH OF CHILDREN

USE

Helps protect against cavities.

WARNINGS

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 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

INGREDIENTS AND APPEARANCE

PREMIER VALUE CAVITY PROTECTION MINT 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-005
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O)	SODIUM MONOFLUOROPHOSPHATE	7.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor	MINT (Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-005-01	21 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/08/2003

Labeler - Premier Value (101668460)