Zohar Fluoride Anti Cavity Fresh Mint Flavor Paste
FDA Label NDC 84045-006

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zohar Kosher Limited for the product Zohar Fluoride Anti Cavity Fresh Mint Flavor (NDC 84045-006). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, use, warnings, keep out of reach of children under 6 years of age., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

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

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warnings

Do not use if irritation occurs and persists.

Keep Out Of 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

  • 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

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

Package Labeling:

Label06 (Label06)

Label06 (Label06)

Label07 (Label07)

Label07 (Label07)

* Please review the disclaimer below.