Zohar Fluoride Anti-cavity Regular Mint Flavour Paste
FDA Label NDC 84045-005
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 Regular Mint Flavour (NDC 84045-005). 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, do not use if, 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
Active Ingredients
Sodium Monofluorophosphate 0.76% (0.1% w/v fluoride ion)
Purpose
Anticavity
Use
Aids in the prevention of dental cavities
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 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 |
Inactive Ingredients
Calcium Carbonate, Glycerin, Water, Hydrated Silica, Sodium Lauryl Sulfate, Cellulose Gum, Sodium Benzoate, Spearmint Oil, Laevo Carvone, Flavor, Sodium Saccharin.
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