Zohar Anti Cavity Mouthwash Coolmint Flavour Liquid
FDA Label NDC 84045-001

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 Anti Cavity Mouthwash Coolmint Flavour (NDC 84045-001). 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 ingredient, purpose, use, keep out of reach of children., directions, inactive ingredients, label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Keep Out Of Reach Of Children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 6 years of age and older:
  • use once a day after brushing your teeth with a toothpaste 
  • vigorously swish 10 ml (2teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse 
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary untill capable of using without supervision.
  • Children under 6 years of age:consult a dentist or doctor.

Inactive Ingredients

Water, Xylitol, Glycerin, Sodium Benzoate, Flavor, Sodium Citrate, Sodium Saccharin, Citric Acid, Poloxamer 407, FD&C Blue #1.

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