Otc - Active Ingredient
Sodium Monofluorophosphate - .76%
(Total Fluoride Content - 1000 ppm Approx.)
Freshmint Anticavity Fluoride Paste, Dentifrice
FDA Label NDC 51824-123
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by New World Imports, Inc for the product Freshmint Anticavity Fluoride (NDC 51824-123). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anticavity
Otc - Keep Out Of Reach Of Children
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 right away.
Indications & Usage
Aids in the prevention of dental cavities
Warnings
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 right away.
Dosage & Administration
Adults and Children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as instructed by a dentist or doctor.
- do not swallow
- instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing use a pea-sized amount)
- supervise children as necessary until capable of using without supervision
Children under 2 years of age:consult a dentist or doctor
Inactive Ingredient
Calcium Carbonate, Water, Sorbitol, Silica, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Sodium Silicate, Tetrasodium Pyrophosphate, Sodium Saccharin, Titanium Dioxide, PEG-400, Sodium Benzoate
Package Label.Principal Display Panel
Jpeg Content (Tp15)
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