Label: PERIOSCIENCES WHITE CARE AO PRO- sodium fluoride paste, dentifrice
- NDC Code(s): 53238-001-90
- Packager: PERIOSCIENCES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 October 14, 2022
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- Official Label (Printer Friendly)
- PERIOSCIENCES White Care AO Pro Toothpaste
- Active ingredient
- Purpose
- Uses
- Warning
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Directions
- Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
- Children under 2 years of age: Ask a dentist or physician
- Other information
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Inactive ingredients
glycerin, aqua (water), hydrated silica, sorbitol, propylene glycol, sodium methyl cocoyl taurate, pvp, hydroxyapatite, cocamidopropyl betaine, ferulic acid, phloretin, hesperetin, menthol, mentha piperita (peppermint) oil, sodium ascorbyl phosphate, sodium olivoyl glutamate, citrus grandis (grapefruit) fruit extract, stevia rebaudiana bertoni, sodium citrate, ethylhexylglycerin, cellulose gum, potassium sorbate, titanium dioxide, phenoxyethanol, sodium polyphosphate, caprylyl glycol
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- PRINCIPAL DISPLAY PANEL
- PERIOSCIENCES White Care AO Pro Toothpaste 90ml (53238-001-90)
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INGREDIENTS AND APPEARANCE
PERIOSCIENCES WHITE CARE AO PRO
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53238-001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.24 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) FERULIC ACID (UNII: AVM951ZWST) PHLORETIN (UNII: S5J5OE47MK) HESPERETIN (UNII: Q9Q3D557F1) MENTHOL (UNII: L7T10EIP3A) PEPPERMINT OIL (UNII: AV092KU4JH) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) PUMMELO (UNII: ET1TN5W71X) STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2) SODIUM CITRATE (UNII: 1Q73Q2JULR) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) CAPRYLYL GLYCOL (UNII: 00YIU5438U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53238-001-90 1 in 1 CARTON 09/13/2012 1 90 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 09/13/2012 Labeler - PERIOSCIENCES LLC (961798605) Establishment Name Address ID/FEI Business Operations Chemolee Lab Corp 809982754 manufacture(53238-001)
