PREMIERPRO FLUORIDE TOOTH- sodium monofluorophosphate paste, dentifrice

PremierPro Fluoride Tooth by

Drug Labeling and Warnings

PremierPro Fluoride Tooth by is a Otc medication manufactured, distributed, or labeled by SVS, LLC (DBA S2S Global). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Sodium Monofluorophosphate (0.76%)

PURPOSE

Purpose: Anticavity

INDICATIONS & USAGE

Uses: Aids in the prevention of dental cavities

WARNINGS

For external use only.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under six years of age

ASK DOCTOR

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

DOSAGE & ADMINISTRATION

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.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREMIERPRO FLUORIDE TOOTH 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69392-001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69392-001-01	14 g in 1 TUBE
2	NDC: 69392-001-02	24 g in 1 TUBE
3	NDC: 69392-001-03	42 g in 1 TUBE
4	NDC: 69392-001-04	78 g in 1 TUBE
5	NDC: 69392-001-05	85 g in 1 TUBE
6	NDC: 69392-001-06	130 g in 1 TUBE
7	NDC: 69392-001-07	198 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/2015

Labeler - SVS, LLC (DBA S2S Global) (831375089)

Registrant - SVS, LLC (DBA S2S Global) (831375089)