Zohar Fluoride Anti Cavity Fresh Mint Flavor

Manufacturer
ZOHAR KOSHER LIMITED
Effective date
2024-02-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:53

Label at a glance#

ProductZohar Fluoride Anti Cavity Fresh Mint Flavor
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure6 sections

Dosage and administration

Do not swallow Supervise children as necessary until capable of using without supervision.  Adults and children 2 years of age and older Brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician.  Children under 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 ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

Do not use if irritation occurs and persists.

Keep out of 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

  • Do not swallow
  • Supervise children as necessary until capable of using without supervision.
 Adults and children 2 years of age and olderBrush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician.
 Children under 6 yearsUse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
 Children under 2 yearsAsk a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

Calcium Carbonate, Water, Glycerin, Hydrated Silica, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Benzoate, Sodium Saccharin. 

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label06Label06Label07Label07

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84045-006-00Zohar Fluoride Anti Cavity Fresh Mint Flavor113 g in 1 TUBEPASTE1131
84045-006-00Zohar Fluoride Anti Cavity Fresh Mint Flavor1 in 1 CARTONPASTE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84045-006ZOHAR FLUORIDE ANTI CAVITY FRESH MINT FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE [ZOHAR KOSHER LIMITED]12 package rows20240316_f36f8b13-c5d2-4dfa-ae40-d957e49e701a.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84045-00684045-006-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
1263b2b4-ddfa-7aff-e063-6394a90ae98af36f8b13-c5d2-4dfa-ae40-d957e49e701a2024-02-27WarningsExact identifier
spl id: 1263b2b4-ddfa-7aff-e063-6394a90ae98a
spl set id: f36f8b13-c5d2-4dfa-ae40-d957e49e701a

Reported adverse events (FAERS/openFDA)#

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