FDA.reportPublic FDA data

Pearl White

Manufacturer
BEYOND TECHNOLOGY CORP.
Effective date
2012-03-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:35:07

Label at a glance#

ProductPearl White
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure10 sections

Dosage and administration

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 dent...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Potassium nitrate 5%

Sodium fluoride (10% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Antisensitivity

Anticavity

Use

INDICATIONS & USAGE SECTION

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by:

BEYOND Dental and Health USA

Stafford, TX 77477 USA

Copyright 2010 Beyond Dental and Health Inc.

www.360oralcare.com

Principal Display Panel

PACKAGE LABEL.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
Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42199-005-052020-12-14C16284748780-19855e2a2-409b-60a7-e053-dbdaa90a05bdPearl White Sensitivity Formula
42199-005-062020-12-14C16284748780-19855e2a2-409b-60a7-e053-dbdaa90a05bdPearl White Sensitivity Formula
42199-005-052019-11-27C16284748780-19855e2a2-409b-60a7-e053-dbdaa90a05bdPearl White Sensitivity Formula
42199-005-062019-11-27C16284748780-19855e2a2-409b-60a7-e053-dbdaa90a05bdPearl White Sensitivity Formula

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0Z1
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W71
FLUORIDE IONACTIVE MOIETYQ80VPU408O1
NITRATE IONACTIVE MOIETYT93E9Y28441
CALCIUM PEROXIDEINACTIVE INGREDIENT7FRO2ENO911
GAULTHERIA PROCUMBENS LEAFINACTIVE INGREDIENT2125M16OWN1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P91
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%)INACTIVE INGREDIENTX70SE62ZAR1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9M1
PROPANEDIOLINACTIVE INGREDIENT5965N8W85T1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TY1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1
SODIUM PERBORATEINACTIVE INGREDIENTY52BK1W96C1
SORBITOLINACTIVE INGREDIENT506T60A25R1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z281
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42199-00542199-005-05, 42199-005-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
PROPANEDIOL5965N8W85TIACT
SODIUM LAURYL SULFATE368GB5141JIACT
POWDERED CELLULOSESMD1X3XO9MIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%)X70SE62ZARIACT
GAULTHERIA PROCUMBENS LEAF2125M16OWNIACT
SODIUM BENZOATEOJ245FE5EUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SACCHARIN SODIUM DIHYDRATESB8ZUX40TYIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
CALCIUM PEROXIDE7FRO2ENO91IACT
SODIUM PERBORATEY52BK1W96CIACT
STARCH, CORNO8232NY3SJIACT
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 279 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SORBITOLSORBITOL506T60A25RTABLET, COATED / ORAL12.96 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION / INTRAVENOUS864 mgExact identifier — unii candidate
35 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SOLUTION / ORAL199 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, FILM COATED / ORAL21.8 mgExact identifier — unii candidate
10 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED, EXTENDED RELEASE / ORAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUSPENSION / ORAL113 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSYSTEM / TOPICAL420 mgExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION, SOLUTION / INTRAMUSCULAR4.8 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSHAMPOO, SUSPENSION / TOPICAL40 %w/vExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSPONGE / TOPICAL5 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / SUBLINGUAL1.1 mgExact identifier — unii candidate
42 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE, DENTIFRICE / DENTAL14 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
36 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE / ORAL5785 mgExact identifier — unii candidate
22 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYFILM / BUCCAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / OPHTHALMIC46 mgExact identifier — unii candidate
36 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET / SUBLINGUAL99.2 mgExact identifier — unii candidate
10 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii candidate
35 equally ranked IID candidates
POWDERED CELLULOSEPOWDERED CELLULOSESMD1X3XO9MLIQUID / ORALNAExact identifier — unii candidate
16 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRAVENOUS1276 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGEL / TOPICAL0.06 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION, CONCENTRATE / ORAL2813 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPASTE, DENTIFRICE / DENTAL1.4 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
POWDERED CELLULOSEPOWDERED CELLULOSESMD1X3XO9MCAPSULE / ORAL2430 mgExact identifier — unii candidate
16 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSHAMPOO, SUSPENSION / TOPICAL3 %w/vExact identifier — unii candidate
40 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION, EXTENDED RELEASE / ORAL113 mgExact identifier — unii candidate
22 equally ranked IID candidates
POWDERED CELLULOSEPOWDERED CELLULOSESMD1X3XO9MTABLET, FILM COATED / ORAL392 mgExact identifier — unii candidate
16 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION/ DROPS / OPHTHALMIC1 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
36 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SOLUTION / ORAL98 mgExact identifier — unii candidate
35 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCREAM / VAGINAL12 mgExact identifier — unii candidate
42 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYWAFER / ORAL8 mgExact identifier — unii candidate
34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii candidate
35 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM / BUCCAL3 mgExact identifier — unii candidate
40 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION, SOLUTION / INTRAMUSCULAR20.3 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYCONCENTRATE / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii candidate
40 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYSTEM / TOPICAL6300 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JOINTMENT / TOPICAL14 mgExact identifier — unii candidate
42 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION / INTRAMUSCULAR406 mgExact identifier — unii candidate
36 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, CHEWABLE / ORAL130 mgExact identifier — unii candidate
10 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SUSPENSION / ORAL160 mgExact identifier — unii candidate
35 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET / SUBLINGUAL50.5 mgExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii candidate
40 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQLIQUID / TOPICAL1 %w/wExact identifier — unii candidate
36 equally ranked IID candidates

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
b67476a4-59da-16e0-e053-2995a90a05339e41441f-c466-46e0-9114-17a61c5aa4552020-12-14WarningsExact identifier
spl set id: 9e41441f-c466-46e0-9114-17a61c5aa455

Reported adverse events (FAERS/openFDA)#

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