Active Ingredient
Sodium Fluoride - 0.22% (0.1%w/v fluoride ion)
Safetymaxx Mint Flavor
FDA Label NDC 60371-344
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fsi, Inc. for the product Safetymaxx Mint Flavor (NDC 60371-344). 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 active ingredient, purpose, use:, warnings, otc - keep out of reach of children, directions, inactive ingredients, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity
Use:
Helps protect against cavities
Warnings
If more than used for brushing is swallowed, get medical help or contact a Poison Control Center immediately.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6years of age.
Directions
Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist.
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 Ingredients
Purified water, Sorbitol, Carbopol, Sodium Lauryl Sulphate, Flavor, Poly Ethylene Glycol 1500, Sodium Saccharin, Precipitated Silica, Sodium Carboxy Methyl Cellulose, Methyl Paraben, Propyl Paraben
Other
Product of China, Exclusively produced for FSi, Inc. 1-800-647-5923 www.myfsi.net Expires 2 years from the DAte of Mfg
FSi, Inc Nashville TN 37210
Product Tube Label
Safetymaxx Toothgel (Safetymaxxtoothgel)
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