FDA.reportPublic FDA data

Plus White Extra Whitening

Manufacturer
CCA Industries LLC | Sheffield Pharmaceuticals LLC
Effective date
2019-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:02:24

Label at a glance#

ProductPlus White Extra Whitening
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure10 sections

Dosage and administration

adults and children 2 years and older Brush teeth thoroughly, after each meal, or at least twice a day, or as directed by a dentist or physician to minimize swallowing for children under the age of 6, use a pea size amountandsupervisebrushinguntil good habitsare established children under 2 years of ask a dentistor physician

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION



Sodium Monofluorophosphate 0.83% (0.15% w/v fluoride ion)               

Purpose

OTC - PURPOSE SECTION

Anticavity whitening toothpaste

Use

INDICATIONS & USAGE SECTION

Aids in the removal of stains and prevention of dental decay.

Warnings 

WARNINGS SECTION

If more than used for brushing is accidentallly swallowed, get medical help or contact a  Poison Control Center  right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. 

Directions 

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years and older
  • Brush teeth thoroughly, after each meal, or at least twice a day, or as directed by a dentist or physician
  • to minimize swallowing for children under the age of 6, use a pea size amountandsupervisebrushinguntil good habitsare established
  • children under 2 years of ask a dentistor physician

INACTIVE INGREDIENT SECTION

Inactive ingredients Hydrated Silica, Sorbitol, Water (Aqua), Dicalcium Phosphate, Glycerin, PVM/MA Copolymer, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Titanium Dioxide, Trisodium Phosphate, Sodium Saccharin, Blue 1

OTC - QUESTIONS SECTION

Questions or comments? Call Toll Free1-800-595-6230
- www.pluswhite.com

Plus White Extra Whitening -Carton 3.5 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Plus+White Extra Whitening 

Fluoride Protection

Fluoride Anticavity toothpaste

NET WT. 3.5 oz (100G)

Plus White Extra Whitening -Carton 3.5 ozPlus White Extra Whitening -Carton 3.5 oz

Plus White Extra Whitening -Tube 3.5 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Plus +White Extra Whitening 

Fluoride Protection

NET WT 3.5 oz (100G)

Plus White Extra Whitening -Tube 3.5 ozPlus White Extra Whitening -Tube 3.5 oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1247591sodium monofluorophosphate 0.83 % (fluoride 0.11 % ) ToothpastePSN2
1247591sodium monofluorophosphate 0.0083 MG/MG ToothpasteSCD2
1247591sodium monofluorophosphate 0.83 % ToothpasteSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61543-1502-32025-01-30C16284748780-12cef2736-b1b0-d83d-e063-dadaa90ab31fPlus White Extra Whitening Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61543-1502-3Plus White Extra Whitening1 in 1 CARTONPASTE, DENTIFRICE12
61543-1502-3Plus White Extra Whitening100 g in 1 TUBEPASTE, DENTIFRICE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61543-1502PLUS WHITE EXTRA WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [CCA INDUSTRIES LLC]2Legacy NDC, 2 package rows20191227_e488a39b-eb29-40ed-abc6-b238b05eac29.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61543-150261543-1502-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
COPOVIDONE K25-31D9C330MD8BIACT
TRIBASIC SODIUM PHOSPHATEA752Q30A6XIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT

Source Document#

Source XML · Source PDF

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
d741e08c-11d9-4756-bc79-228aab723371e488a39b-eb29-40ed-abc6-b238b05eac292019-12-26WarningsExact identifier
spl id: d741e08c-11d9-4756-bc79-228aab723371
spl set id: e488a39b-eb29-40ed-abc6-b238b05eac29

Reported adverse events (FAERS/openFDA)#

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