PREMIERPRO FLUORIDE TOOTH- sodium monofluorophosphate paste, dentifrice 
SVS, LLC (DBA S2S Global)

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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Active Ingredient: Sodium Monofluorophosphate (0.76%)

Purpose: Anticavity

Uses: Aids in the prevention of dental cavities

For external use only.

Keep out of reach of children under six years of age

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

Adults and children of two years of age and older: Brush teeth thoroughly, perferrably after each meal or at least twice a day, or as directed by a dentist or a doctor. Instruct children under six years of age in good brushing and rinsing habit (to minimize swollowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: consult a dentist or physician.

Calcium Carbonate, Carboxymethylcellulose Sodium, Flavour, Glycerin, Purified Water, Sodium Benzoate, Sodium Lauryl Sulfate, Hydrated Silica, Saccharin Sodium, Sorbitol, Tetrasodium Diphosphate.

label

PREMIERPRO FLUORIDE TOOTH 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69392-001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 100-200 MPA.S AT 1%) (UNII: 99H65D77XY)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69392-001-0114 g in 1 TUBE
2NDC:69392-001-0224 g in 1 TUBE
3NDC:69392-001-0342 g in 1 TUBE
4NDC:69392-001-0478 g in 1 TUBE
5NDC:69392-001-0585 g in 1 TUBE
6NDC:69392-001-06130 g in 1 TUBE
7NDC:69392-001-07198 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/2015
Labeler - SVS, LLC (DBA S2S Global) (831375089)
Registrant - SVS, LLC (DBA S2S Global) (831375089)

Revised: 1/2015
Document Id: 946328f8-56db-4928-b767-30f65e8114fc
Set id: 7faa8f2c-c583-4a3a-9fd7-c48a439bce5d
Version: 2
Effective Time: 20150119
 
SVS, LLC (DBA S2S Global)