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 International Inc., Beyond International Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients

Potassium nitrate 5%
Sodium fluoride 0.24% (0.10% w/v Fluoride Ion)

PURPOSE

Purpose

Antihypersensitivity

Anticavity

INDICATIONS & USAGE

Uses

• Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets or contact.
• Aids in the prevention of dental cavities.

WARNINGS

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.

STOP USE

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.
• Pain/sensitivity still persists after 4 weeks of use.

DOSAGE & ADMINISTRATION

Directions

Adults and Children 12 years of age and older

• Apply at least a 1-inch strip of toothpaste onto a soft bristle toothbrush.
• Brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as directed by a dentist or doctor.
• Do not swallow. Spit out after brushing.

Children under 12 years of age: Consult a dentist or doctor.

INACTIVE INGREDIENT

Inactive ingrediets

sorbitol, hydrated silica, aqua, propanediol, PEG1450, sodium lauryl sulfate, PEG 400, gaultheria procumbens leaf extract, zea mays starch, calcium peroxide, sodium carboxymethyl cellulose, titanium dioxide, hydroxyethylcellulose, sodium saccharin, sodium benzoate.

QUESTIONS

Questions or comments? 866-695-6452

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Developed and manufactured with pride by:

BEYOND INTERNATIONAL INC.

12503 Exchange Dr. Suite 530

Stafford, TX 77477 USA

©2017 BEYOND INTERNATIONAL INC.

www.beyonddent.com

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PEARL WHITE

Sensitivity Formula:

• Prevents cavities
• Reduces tartar build-up
• Reduces 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.

PRINCIPAL DISPLAY PANEL

PEARL WHITE

SENSITIVITY WHITENING TOOTHPASTE

with Fluoride

NET WT. 4.76 OZ. (135 g)

INGREDIENTS AND APPEARANCE

PEARL WHITE 
potassium nitrate, sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42199-006
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 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1 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)
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)
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42199-006-05	1 in 1 CARTON	06/12/2017
1		120 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 42199-006-06	1 in 1 CARTON	06/12/2017
2		40 g 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	06/12/2017

Labeler - Beyond International Inc. (080721790)

Establishment
Name	Address	ID/FEI	Business Operations
Beyond International Inc		080721790	manufacture(42199-006)