FDA.reportPublic FDA data

Pearl White

Manufacturer
Beyond International Inc. | Beyond International Inc
Effective date
2023-11-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:02:49

Label at a glance#

ProductPearl White
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure13 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

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

OTC - PURPOSE SECTION

Purpose

Antihypersensitivity

Anticavity

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION


Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

OTC - STOP USE SECTION

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 SECTION

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 SECTION

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.

OTC - QUESTIONS SECTION

Questions or comments? 866-695-6452

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PEARL WHITE

SENSITIVITY WHITENING TOOTHPASTE

with Fluoride

NET WT. 4.76 OZ. (135 g)

Toothpaste Pearl WhiteToothpaste Pearl White

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42199-006-05Pearl White1 in 1 CARTONPASTE, DENTIFRICE12
42199-006-05Pearl White120 g in 1 TUBEPASTE, DENTIFRICE1202
42199-006-06Pearl White1 in 1 CARTONPASTE, DENTIFRICE12
42199-006-06Pearl White40 g in 1 TUBEPASTE, DENTIFRICE402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42199-006PEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND INTERNATIONAL INC.]2Current NDC, Legacy NDC, 4 package rows20231129_51c79544-9536-5863-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42199-00642199-006-05, 42199-006-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
PROPANEDIOL5965N8W85TIACT
SODIUM LAURYL SULFATE368GB5141JIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%)X70SE62ZARIACT
GAULTHERIA PROCUMBENS LEAF2125M16OWNIACT
SODIUM BENZOATEOJ245FE5EUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
CALCIUM PEROXIDE7FRO2ENO91IACT
STARCH, CORNO8232NY3SJIACT
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM
POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4IACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pearl WhitePOTASSIUM NITRATE, SODIUM FLUORIDEBeyond International Inc.51c79544-9536-5863-e054-00144ff8d46c2023-11-28WarningsExact identifier
ndc (package): 42199-006-06
ndc (package): 42199-006-05
ndc (product): 42199-006
ndc11 (package): 42199000606
ndc11 (package): 42199000605
spl id: 0b3e6b1d-3644-3f2c-e063-6394a90a25a1
spl set id: 51c79544-9536-5863-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.