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Pearl White by BEYOND TECHNOLOGY CORP.

Medically reviewed on March 9, 2018

Dosage form: paste, dentifrice
Ingredients: POTASSIUM NITRATE 0.05mg in 1g, SODIUM FLUORIDE 0.10mg in 1g
Labeler: BEYOND TECHNOLOGY CORP.
NDC Code: 42199-005

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.

Pearl White Sensitivity Formula

DRUG FACTS

Active Ingredients

Potassium nitrate 5%

Sodium fluoride (10% w/v fluoride ion)

Purpose

Antisensitivity

Anticavity

Use
  • When used regularly, helps protect against hypersensitivity.
  • Aids in prevention of dental cavities.

Warnings


  • Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Do not swallow.
  • Should be used as part of an oral health program that includes regular flossing and dental check-ups.
  • Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Children under 6 years of age should use only a pea-sized amount and be supervised to brush properly and to not swallow. In case of intake of fluoride from other sources consult a dentist or doctor.
  • Supervise children of 12 years and younger as necessary until capable of using without supervision.
  • Consult a health care practitioner before using in children younger than 6 years of age.

Inactive ingredients

Sorbitol, hydrated silica, aqua, prpanediol, sodium lauryl sulfate, cellulose, PEG 400, hydroxyethylellulose, gaultheria procmbens leaf extract, pearl powder, sodium benzoate, titanium dioxide, sodium saccharin, hydroxyapatite, calcium peroxide, sodium perborate, zea mays starch

Questions?

1-888-695-6452 M-F 9:00 a.m. - 5:30 p.m. CST

Distributed by:

BEYOND Dental and Health USA

Stafford, TX 77477 USA

Copyright 2010 Beyond Dental and Health Inc.

www.360oralcare.com

Principal Display Panel

Pearl White

Whitening Toothpaste with Fluoride

Sensitivity Formula

NET WT 4.2 OZ (120g)

Sensitivity Formula:

  • Prevents cavities
  • Reduces tartar build-up
  • Eliminates plaque
  • Freshens Breath

WITH REGULAR USE:

•Powerful stain remover, calcium peroxide, dissolves difficult-to-remove stains deep inside teeth. •Surface stains are gently polished away. •Unique formula leaves teeth shiny and sparkling white. •Soothes the irritated nerves in your teeth. •Protects against the causes of hypersensitivity.

For a healthy, shiny, white smile: Brush twice a day, floss daily and visit your dentist regularly.


PEARL WHITE 
potassium nitrate, sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42199-005
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE0.05 mg  in 1 g
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
HYDRATED SILICA 
WATER 
PROPANEDIOL 
SODIUM LAURYL SULFATE 
POWDERED CELLULOSE 
POLYETHYLENE GLYCOL 400 
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) 
GAULTHERIA PROCUMBENS LEAF 
SODIUM BENZOATE 
TITANIUM DIOXIDE 
SACCHARIN SODIUM DIHYDRATE 
TRIBASIC CALCIUM PHOSPHATE 
CALCIUM PEROXIDE 
SODIUM PERBORATE 
STARCH, CORN 
Packaging
#Item CodePackage Description
1NDC:42199-005-051 TUBE (TUBE) in 1 CARTON
1120 g in 1 TUBE
2NDC:42199-005-061 TUBE (TUBE) in 1 CARTON
240 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/05/2007
Labeler - BEYOND TECHNOLOGY CORP. (653759626)
Establishment
NameAddressID/FEIOperations
BEYOND TECHNOLOGY CORP. 653759626manufacture(42199-005)

 
BEYOND TECHNOLOGY CORP.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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