FDA Label for Anticavity Fluoride Rinse
View Indications, Usage & Precautions
Anticavity Fluoride Rinse Product Label
The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Sodium fluoride 0.05% (0.02% w/v fluoride ion)
Purpose
Anticavity
Use
aids in the prevention of dental cavities
Warning
For this product
Keep Out Of Reach Of Children.
If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.
Directions
- adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
- remove cap
- pour 10 milliliters (10 ML mark on inside of cap); do not fill above 10 ML mark
- vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
- do not swallow the rinse
- do not eat or drink for 30 minutes after rinsing
- instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
- supervise children as necessary until capable of using without supervision
- children under 6 years of age: consult a dentist or doctor
Other Information
- store at room temperature
Inactive Ingredients
water, glycerin, sodium benzoate, potassium sorbate, flavor, xylitol, citric acid, sucralose, sodium citrate
Questions Or Comments?
1-888-423-0139
Tamper Evident Statement
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
Adverse Reactions
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ITASCA, IL 60143 ©TOPCO VIJA0624
QUESTIONS? 1-888-423-0139
[email protected] www.topcarebrand.com
Scan here for more information or call 1-888-423-0139
QUALITY GUARANTEED
Disclaimer
*This product is not manufactured or distributed by Dr. Harold Katz, LLC., distributor of TheraBreath® for Kids! Oral Rinse
Principal Display Panel
COMPARE TO THERABREATH ® FOR KIDS! ORAL RINSE*
TopCare ®everyday
Kids Anticavity
Fluoride Oral Rinse
Watermelon Flavored
- Helps prevent cavites & strengthens teeth
- Dye, Paraben, Alcohol, and Sugar Free
IMPORTANT: read directions for proper use.
10 FL OZ (296 mL)
* Please review the disclaimer below.
