PERIOSCIENCES SENSITIVE AO PRO- potassium nitrate, sodium monofluorophosphate paste, dentifrice

PERIOSCIENCES SENSITIVE AO Pro by

Drug Labeling and Warnings

PERIOSCIENCES SENSITIVE 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 SENSITIVE AO ProToothpaste

Active ingredient

Potassium nitrate 5%
Sodium monofluorophosphate 0.76%

Purpose

Antisensitivity
Anticavity

Uses

Builds protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact. Aids in the prevention of dental cavities

Warning

When using this product

do not use longer than four weeks unless recommended by a dentist.

Stop use and ask a dentist

if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Keep out of reach of children.

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

Directions

• Adults and children 12 years of age and older:  Apply at least a 1-inch strip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Make sure to brush all sensitive areas of the teeth.
• 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, sodium bicarbonate, pvp, cocamidopropyl betaine, cellulose gum, hydroxyapatite, ferulic acid, phloretin, silyburn marianum (milk thistle) fruit extract, sodium ascorbyl phosphate, allantoin, potassium sorbate, potassium chloride, menthol, mentha arvensis (wild mint) leaf oil, sodium polyphosphate, stevia rebaudiana bertoni, titanium dioxide, sodium citrate

Questions or Comments?

Call toll-free  1-800-915-8110

SENSITIVE AO ProToothpaste

AO Pro Toothpaste/Sensitive fight tooth sensitivity and cavities and is fortified with naturally sourced antioxidants and targeted botanical extracts that soothe sensitive oral tissues.

For best results, use with AO ProRinse/Sensitive 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 SENSITIVE AO ProToothpaste  Antioxidant gel toothpaste to provide soothing comfort and relieve tooth sensitivity  Net 3 fl oz / 90 ml  REDEFINING ORAL CARE  WITH ANTIOXIDANTS

PERIOSCIENCES SENSITIVE AO ProToothpaste 90ml (

53238-002-90)

INGREDIENTS AND APPEARANCE

PERIOSCIENCES SENSITIVE AO PRO 
potassium nitrate, sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53238-002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	50 mg  in 1 mL
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)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
FERULIC ACID (UNII: AVM951ZWST)
PHLORETIN (UNII: S5J5OE47MK)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
ALLANTOIN (UNII: 344S277G0Z)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
MENTHOL (UNII: L7T10EIP3A)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53238-002-90	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 not final	part356	05/27/2013

Labeler - PERIOSCIENCES LLC (961798605)

Establishment
Name	Address	ID/FEI	Business Operations
Chemolee Lab Corp		809982754	manufacture(53238-002)