Label: PREMIERPRO FLUORIDE TOOTH- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 69392-001-01, 69392-001-02, 69392-001-03, 69392-001-04, view more69392-001-05, 69392-001-06, 69392-001-07 - Packager: SVS, LLC (DBA S2S Global)
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated January 19, 2015
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- ASK DOCTOR
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PREMIERPRO FLUORIDE TOOTH
sodium monofluorophosphate paste, dentifriceProduct 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)