PEARL WHITE- potassium nitrate, sodium fluoride paste, dentifrice

Pearl White by

Drug Labeling and Warnings

Pearl White by is a Otc medication manufactured, distributed, or labeled by BEYOND TECHNOLOGY CORP. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

• 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

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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.

INGREDIENTS AND APPEARANCE

PEARL WHITE 
potassium nitrate, sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42199-005
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	0.05 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 DIHYDRATE (UNII: SB8ZUX40TY)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)
SODIUM PERBORATE (UNII: Y52BK1W96C)
STARCH, CORN (UNII: O8232NY3SJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42199-005-05	1 in 1 CARTON
1		120 g in 1 TUBE
2	NDC: 42199-005-06	1 in 1 CARTON
2		40 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/05/2007

Labeler - BEYOND TECHNOLOGY CORP. (653759626)

Establishment
Name	Address	ID/FEI	Business Operations
BEYOND TECHNOLOGY CORP.		653759626	manufacture(42199-005)