PERIOSCIENCES HYDRATING AO PRO- sodium monofluorophosphate paste, dentifrice

PERIOSCIENCES HYDRATING AO Pro by

Drug Labeling and Warnings

PERIOSCIENCES HYDRATING AO Pro by is a Otc medication manufactured, distributed, or labeled by PERIOSCIENCES LLC, Chemolee Lab Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PERIOSCIENCES HYDRATING AO ProToothpaste

Active ingredient

Sodium monofluorophosphate 0.76%

Purpose

Anticavity

Uses

Aids in prevention of dental cavities

Warning

Keep out of reach of children under 2 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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

Not intended for ingestion. Upon application in the mouth, if you experience any irritation or unusual sensitivity, discontinue and consult your dental professional.

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?

Call toll-free  1-800-915-8110

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  Antioxidant gel toothpaste with targeted moisturizers to revitalize oral tissues  Net 3 fl oz / 90 ml  REDEFINING ORAL CARE  WITH ANTIOXIDANTS

PERIOSCIENCES HYDRATING AO ProToothpaste 90ml (

53238-003-90)

INGREDIENTS AND APPEARANCE

PERIOSCIENCES HYDRATING AO PRO 
sodium monofluorophosphate paste, dentifrice

Product 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)