FDA.reportPublic FDA data

Plus White Smokers Whitening

Manufacturer
CCA Industries, Inc. | Sheffield Pharmaceuticals LLC
Effective date
2019-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:02:22

Label at a glance#

ProductPlus White Smokers Whitening
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 sections

Indications and uses

 Aids in the prevention of dental decay.

Dosage and administration

 This toothpaste is formulated for adults 18 and over who smoke tobacco - It should not be utilized by children under 18 years old without consulting a dentist or physician - Brush teeth thoroughly, preferably after each meal, or at least twice a day, or when new stains are apparent.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION



Sodium Monofluorophosphate 0.83%  (0.11% w/v fluoride ion)                           

Purpose

OTC - PURPOSE SECTION

Anticavity Toothpaste

Uses

INDICATIONS & USAGE SECTION

 Aids in the prevention of dental decay.

Warnings

WARNINGS SECTION

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

Directions 

DOSAGE & ADMINISTRATION SECTION

 This toothpaste is formulated for adults 18 and over who smoke tobacco

- It should not be utilized by children under 18 years old without consulting a dentist or physician
- Brush teeth thoroughly, preferably after each meal, or at least twice a day, or when new stains are apparent.

INACTIVE INGREDIENT SECTION

Inactive ingredients Sorbitol, Hydrated Silica, Water (Purified), Dicalcium Phosphate, Glycerin, PVM/MA Copolymer, Flavor, Sodium lauryl Sulfate, Cellulose Gum, Titanium Dioxide, Trisodium Phosphate, Sodium Saccharin, Blue 1, Yellow 5

OTC - QUESTIONS SECTION

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

Principal Display Panel -Tube 3.5 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Plus+White
THE SMOKER'S WHITENING TOOTHPASTE

Net Wt 3.5 oz (100G) - Fluoride Anticavity Toothpaste

Principal Display Panel -Tube 3.5 ozPrincipal Display Panel -Tube 3.5 oz

Principal Display Panel -Tube 3.5 ozPrincipal Display Panel -Tube 3.5 oz

Principal Display Panel -Tube 3.5 ozPrincipal Display Panel -Tube 3.5 oz
Principal Display Panel -Tube 3.5 ozPrincipal Display Panel -Tube 3.5 oz

Principal Display Panel - Carton 3.5 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - Carton 3.5 ozPrincipal Display Panel - Carton 3.5 ozPlus + White 

The Smokers Whitening Toothpaste 

NET WT 3.5 oz (100G) Fluoride Anticavity Toothpaste 

Principal Display Panel - Carton 3.5 ozPrincipal Display Panel - Carton 3.5 oz

Principal Display Panel - Carton 3.5 ozPrincipal Display Panel - Carton 3.5 oz

Principal Display Panel - Carton 3.5 ozPrincipal Display Panel - Carton 3.5 oz

Principal Display Panel - Carton 3.5 ozPrincipal Display Panel - Carton 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
61543-1554-32025-01-30C16284748780-12cef2736-6ab6-d83d-e063-dadaa90ab31fPlus White Smokers Whitening

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61543-1554-3Plus White Smokers Whitening100 g in 1 TUBEPASTE, DENTIFRICE1002
61543-1554-3Plus White Smokers Whitening1 in 1 CARTONPASTE, DENTIFRICE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61543-1554PLUS WHITE SMOKERS WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [CCA INDUSTRIES, INC.]2Legacy NDC, 2 package rows20191227_784ac65d-4604-4399-8645-a8338b25aece.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61543-155461543-1554-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
GLYCERINPDC6A3C0OXIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
COPOVIDONE K25-31D9C330MD8BIACT
TRISODIUM DIPHOSPHATEAR7OGW33N1IACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

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
0524f242-92ea-4fe0-a8f8-8bbea4df59cc784ac65d-4604-4399-8645-a8338b25aece2019-12-26WarningsExact identifier
spl id: 0524f242-92ea-4fe0-a8f8-8bbea4df59cc
spl set id: 784ac65d-4604-4399-8645-a8338b25aece

Reported adverse events (FAERS/openFDA)#

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