FDA Label for Anticavity
View Indications, Usage & Precautions
Anticavity 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 0.02% (0.01% w/v fluoride ion)
Purpose
Anticavity
Use
Aids in the prevention of dental cavities
Warnings
for this product
Keep Out Of Reach Of Children.
If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 6 years of age and older:
- use twice a day after brushing your teeth with a toothpaste
- vigorously swish 10 mL (2 teaspoonfuls) 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
Inactive Ingredients
water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor
Other Information
- store at room temperature (59°-77°F)
Contains peroxide which releases oxygen while whitening. This may cause the bottle to inflate slightly or release air when opened.
Disclaimer
*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Healthy White Vibrant Anticavity Mouthrinse
Adverse Reactions
DISTRIBUTED BY TOPCO ASSOCIATES, LLC
ELK GROVE VILLAGE, IL 60007
[email protected] www.topcarebrand.com
435.000/435AA
Principal Display Panel
TopCare
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
FRESH MINT FLAVOR
Glowing
White
Anticavity
Mouthrinse
- Begins working on contact
- 5 days to whiter teeth
- Helps strengthen teeth
- Kills germs that cause bad breath
IMPORTANT:
read direction for proper use.
COMPARE TO LISTERINE HEALTHYWHITE ANTICAVITY MOUTHRINSE active ingredient
16 FL OZ (1 PT) 474 mL
* Please review the disclaimer below.