The following Structured Product Label (SPL) was submitted to the FDA by Greenbrier International, Inc. for the product Assured Anticavity Fluoride Kids Bubblegum (NDC 33992-0015). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Other information
*Anticavity Fluoride Rinse is not manufactured or distributed by Personal Products Company division or McNeil-PPC., distributor or Act®
DISTRIBUTED BY GREENBRIER INTERNATIONAL, INC.
CHESAPEAKE, VA 23320
MADE IN CANADA
Active Ingredients
Sodium fluoride 0.05% (Fluoride ion-0.0226%)
Purpose
Anticavity rinse
Use aids in the prevention of dental cavities.
Warning
Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
Directions
Inactive ingredients Benzyl Alcohol, Calcium disodium EDTA, Cetylpyridinium Chloride, Disodium Phosphate, Flavor, Poloxamer 407, Polysorbate 80, Propylene Glycol, Red 33, Sodium Benzoate, Sodium Phosphate, Sodium Saccharin, Sorbitol, Water
ASSURED™
Compare to ACT® active ingredient*
Kids Anticavity
Fluoride Rinse
BUBBLEGUM
ALCOHOL FREE
CAVITY PROTECTION
18 FL. OZ. (532 mL)
* Please review the disclaimer below.
