MAXIMUM SECURITY ANTICAVITY

Manufacturer
Bob Barker Company, Inc.
Effective date
2020-01-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:03:34

Label at a glance#

ProductMAXIMUM SECURITY ANTICAVITY
Active ingredientSODIUM FLUORIDE
Label structure7 sections

Dosage and administration

 Adults & Children 6 years of age & older:  Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.  Children 2 to 6 years:  Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).   Children under 2 years:  Ask a dentist or physician. 

Label contents#

Full prescribing information#

Active ingredient:

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride - 0.22% (0.1% w/ fluoride ion)

Purpose:

OTC - PURPOSE SECTION

Anticavity toothpaste

Use:

INDICATIONS & USAGE SECTION

Helps protect against cavities.

Warnings:

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

 Adults & Children 6 years of age & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
 Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing). 
 Children under 2 years: Ask a dentist or physician. 

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water, Sorbitol, Sodium Lauryl Sulfate, Carbomer, Sodium Saccharin, Sodium Hydroxide, PEG-40 Hydrogenated Castor Oil, Flavor, Sodium Benzoate

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245598sodium fluoride 0.22 % ToothpastePSN2
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD2
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53247-200-132022-01-28C16284748780-1d6a99b39-a0c2-a426-e053-dadaa90af4c2MAXIMUM SECURITY ANTICAVITY TOOTHPASTE
53247-200-422022-01-28C16284748780-1d6a99b39-a0c2-a426-e053-dadaa90af4c2MAXIMUM SECURITY ANTICAVITY TOOTHPASTE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53247-200-13MAXIMUM SECURITY ANTICAVITY130 g in 1 TUBEGEL1302
53247-200-42MAXIMUM SECURITY ANTICAVITY4.25 g in 1 PACKETGEL4.252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53247-200MAXIMUM SECURITY ANTICAVITY (SODIUM FLUORIDE) GEL [BOB BARKER COMPANY, INC.]2Legacy NDC, 2 package rows20200201_70d7e4f4-31b1-4626-b28c-0337c85555a1.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53247-20053247-200-42, 53247-200-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
9d739d20-3d31-15e9-e053-2a95a90a604370d7e4f4-31b1-4626-b28c-0337c85555a12020-01-31WarningsExact identifier
spl id: 9d739d20-3d31-15e9-e053-2a95a90a6043
spl set id: 70d7e4f4-31b1-4626-b28c-0337c85555a1

Reported adverse events (FAERS/openFDA)#

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