Otc - Active Ingredient
Active Ingredient: Sodium Monofluorophosphate (0.76%)
Premierpro Fluoride Tooth
FDA Label NDC 69392-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Svs, Llc (dba S2s Global) for the product Premierpro Fluoride Tooth (NDC 69392-001). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, otc - ask doctor, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose: Anticavity
Indications & Usage
Uses: Aids in the prevention of dental cavities
Warnings
For external use only.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under six years of age
Otc - Ask Doctor
If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away
Dosage & Administration
Adults and children of two years of age and older: Brush teeth thoroughly, perferrably after each meal or at least twice a day, or as directed by a dentist or a doctor. Instruct children under six years of age in good brushing and rinsing habit (to minimize swollowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: consult a dentist or physician.
Inactive Ingredient
Calcium Carbonate, Carboxymethylcellulose Sodium, Flavour, Glycerin, Purified Water, Sodium Benzoate, Sodium Lauryl Sulfate, Hydrated Silica, Saccharin Sodium, Sorbitol, Tetrasodium Diphosphate.
Package Label.Principal Display Panel
Label (103)
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