Label: PERIOSCIENCES HYDRATING AO PRO- sodium monofluorophosphate paste, dentifrice
- NDC Code(s): 53238-003-90
- 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 HYDRATING AO ProToothpaste
- 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
aqua (water), glycerin, hydrated silica, xylitol, sorbitol, propylene glycol, sodium methyl cocoyl taurate, propanediol, sodium bicarbonate, pvp, cocamidopropyl betaine, hydroxyapatite, ferulic acid, phloretin, sodium hyaluronate, echinacea purpurea (cone flower) extract, panthenol, menthol, sodium ascorbyl phosphate, zanthoxylum americanum (prickly ash) bark extract, ethyl lauroyl arginate hcl, cellulose gum, stevia rebaudiana bertoni, sodium citrate, potassium sorbate, mentha arvensis (wild mint) leaf oil, potassium chloride
- Questions or Comments?
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HYDRATING AO ProToothpaste
AO Pro Toothpaste/Hydrating is a fluoride toothpaste that cleans teeth gently without abrasion and leaves a hydrated feeling. The multifunctional formula with PerioSciences signature antioxidants and a specific combination of minerals, botanicals and other moisturizers supports your saliva's natural defenses and is ideally suited for dry mouth conditions. Free of alcohol, parabens and sodium lauryl sufate.
For best results, use with AO ProRinse/Hydrating and AO ProVantage Antioxidant Gel.
Manufactured and distributed by:
Periosciences LLC
11700 Preston Road #660
Dallas, TX 75230
www. PerioSciences.com - Made in USA
- PRINCIPAL DISPLAY PANEL
- PERIOSCIENCES HYDRATING AO ProToothpaste 90ml (53238-003-90)
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INGREDIENTS AND APPEARANCE
PERIOSCIENCES HYDRATING AO PRO
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53238-003 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) HYDRATED SILICA (UNII: Y6O7T4G8P9) XYLITOL (UNII: VCQ006KQ1E) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) PROPANEDIOL (UNII: 5965N8W85T) SODIUM BICARBONATE (UNII: 8MDF5V39QO) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) FERULIC ACID (UNII: AVM951ZWST) PHLORETIN (UNII: S5J5OE47MK) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PANTHENOL (UNII: WV9CM0O67Z) MENTHOL (UNII: L7T10EIP3A) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) ETHYL LAUROYL ARGINATE HYDROCHLORIDE (UNII: XPD6ZY79TB) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM CITRATE (UNII: 1Q73Q2JULR) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POTASSIUM CHLORIDE (UNII: 660YQ98I10) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53238-003-90 1 in 1 CARTON 05/27/2013 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 05/27/2013 Labeler - PERIOSCIENCES LLC (961798605) Establishment Name Address ID/FEI Business Operations Chemolee Lab Corp 809982754 manufacture(53238-003)
