FDA.reportPublic FDA data

Plus White Extra Whitening Gel

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 23:02:21

Label at a glance#

ProductPlus White Extra Whitening
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 sections

Indications and uses

 Aids in the prevention of dental cavitites.

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 instruct under 6 years of age in good brushing and rinse habits (it minimizes swallowing), and only use a pea size amount. Children under 2 years ask a dentist or physician

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 cavitites.

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

  •  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
  • instruct under 6 years of age in good brushing and rinse habits (it minimizes swallowing), and only use a pea size amount.
  • Children under 2 years ask a dentist or physician

INACTIVE INGREDIENT SECTION

Inactive ingredients Sorbitol, Hydrated Silica, Glycerin, Water (Purified), PEG 32, Flavor, Sodium lauryl Sulfate, PVM/MA Copolymer, Flavor, Cellulose Gum, Trisodium Phosphate, Sodium Phosphate, Sodium Saccharin, Blue 1, yellow 10

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
Extra Whitening Gel 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 - Carton 3.5 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Plus + White 

Extra Whitening Gel Toothpaste 

NET WT 3.5 oz (100G) Fluoride Anticavity Toothpaste 

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
61543-1606-32025-01-30C16284748780-12cef2736-98b5-d83d-e063-dadaa90ab31fPlus White Extra Whitening Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61543-1606-3Plus White Extra Whitening1 in 1 CARTONGEL, DENTIFRICE12
61543-1606-3Plus White Extra Whitening100 g in 1 TUBEGEL, DENTIFRICE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61543-1606PLUS WHITE EXTRA WHITENING (SODIUM MONOFLUOROPHOSPHATE) GEL, DENTIFRICE [CCA INDUSTRIES, INC.]2Legacy NDC, 2 package rows20191227_4e26d9cf-cee1-47dc-95bd-185ed29dfced.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
61543-160661543-1606-3

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
POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4IACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
COPOVIDONE K25-31D9C330MD8BIACT
TRISODIUM DIPHOSPHATEAR7OGW33N1IACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT

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
64660295-7970-46b2-b789-77c6a5f4ec534e26d9cf-cee1-47dc-95bd-185ed29dfced2019-12-26WarningsExact identifier
spl id: 64660295-7970-46b2-b789-77c6a5f4ec53
spl set id: 4e26d9cf-cee1-47dc-95bd-185ed29dfced

Reported adverse events (FAERS/openFDA)#

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