Otc - Active Ingredient
Sodium Fluoride - 0.22% (0.1% w/v fluoride ion)
Freshmint Anticavity Fluoride Gel, Dentifrice
FDA Label NDC 51824-068
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 51824-068). 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, 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 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
Helps protect against cavities
Warnings
Keep out of reach of children.
Dosage & Administration
Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each mean or at least twice a day, or as directed by a dentist or physician.
Children 2 to 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 Ingredient
Treated Water, Sorbitol, Carbopol, Sodium Lauryl Sulphate, Flavor, Polyethylene Glycol 1500, Sodium Saccharin, Precipiated Silica, Sodium Carboxy Methyl Cellulose, Methylparaben, Propylparaben.
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