FDA.reportPublic FDA data

Maximum Security

Manufacturer
Bob Barker Company Inc. | SKYLARK CMC PVT. LTD.
Effective date
2018-01-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:03:05

Label at a glance#

ProductMaximum Security
Active ingredientSodium Fluoride
Label structure8 sections

Dosage and administration

Do not swallow Supervise children as necessary until capable of using without supervision Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a doctor. Children under 2 years of age: Consult a dentist or doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the 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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not swallow

  • Supervise children as necessary until capable of using without supervision
  • Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing).
  • Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a doctor.
  • Children under 2 years of age: Consult a dentist or doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Purified Water, Precipitated Silica, Sodium Lauryl Sulphate, Poly Ethylene Glycol 32, Flavor, Sodium Carboxymethyl Cellulose, Sodium Saccharin, Sodium Benzoate.

PRINCIPAL DISPLAY PANEL - 4.25 g Packet Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM®
SECURITY

GEL TOOTHPASTE
NET WT .15 OZ (4.25g)

PRINCIPAL DISPLAY PANEL - 4.25 g Packet Label
PRINCIPAL DISPLAY PANEL - 4.25 g Packet Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53247-102-512020-02-19C16284748780-19d75b9d0-3de4-f424-e053-dadaa90a57ceMaximum ® Security
53247-102-522020-02-19C16284748780-19d75b9d0-3de4-f424-e053-dadaa90a57ceMaximum ® Security
53247-102-532020-02-19C16284748780-19d75b9d0-3de4-f424-e053-dadaa90a57ceMaximum ® Security
53247-102-542020-02-19C16284748780-19d75b9d0-3de4-f424-e053-dadaa90a57ceMaximum ® Security
53247-102-552020-02-19C16284748780-19d75b9d0-3de4-f424-e053-dadaa90a57ceMaximum ® Security
53247-102-512020-01-31C16284748780-19d75b9d0-3de4-f424-e053-dadaa90a57ceMaximum ® Security
53247-102-522020-01-31C16284748780-19d75b9d0-3de4-f424-e053-dadaa90a57ceMaximum ® Security
53247-102-532020-01-31C16284748780-19d75b9d0-3de4-f424-e053-dadaa90a57ceMaximum ® Security
53247-102-542020-01-31C16284748780-19d75b9d0-3de4-f424-e053-dadaa90a57ceMaximum ® Security
53247-102-552020-01-31C16284748780-19d75b9d0-3de4-f424-e053-dadaa90a57ceMaximum ® Security

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53247-10253247-102-51, 53247-102-52, 53247-102-53, 53247-102-54, 53247-102-55

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
Sodium Fluoride8ZYQ1474W7ACTIM
Sorbitol506T60A25RIACT
Water059QF0KO0RIACT
Sodium Lauryl Sulfate368GB5141JIACT
Carboxymethylcellulose Sodium, Unspecified FormK679OBS311IACT
Saccharin SodiumSB8ZUX40TYIACT
Sodium BenzoateOJ245FE5EUIACT

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
cf0b5f5b-a179-41d1-b5e1-e5d9b81592fca4b382a0-7e1f-44d6-8942-53e5077917aa2018-01-12WarningsExact identifier
spl id: cf0b5f5b-a179-41d1-b5e1-e5d9b81592fc
spl set id: a4b382a0-7e1f-44d6-8942-53e5077917aa

Reported adverse events (FAERS/openFDA)#

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