PEARL WHITE- potassium nitrate, sodium fluoride paste, dentifrice 
BEYOND TECHNOLOGY CORP.

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.

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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.


Label

PEARL WHITE 
potassium nitrate, sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42199-005
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE0.05 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR)  
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)  
SODIUM PERBORATE (UNII: Y52BK1W96C)  
STARCH, CORN (UNII: O8232NY3SJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42199-005-051 in 1 CARTON10/05/200712/14/2020
1120 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:42199-005-061 in 1 CARTON10/05/200712/14/2020
240 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/05/200712/14/2020
Labeler - BEYOND TECHNOLOGY CORP. (080721790)

Revised: 12/2020
 
BEYOND TECHNOLOGY CORP.