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 Shopko. 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 contct 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 toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute 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 (59⁰ - 77⁰ F)

Disclaimer



This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine HealthyWhite Anticavity Mouthrinse


Other Safety Information



Contains peroxide which releases oxygen while whitening.  This may cause the bottle to inflate slightly or release air when opened.


Adverse Reactions



Manufactured by:

Vi-Jon, 1 Swan Drive

Smyrna, TN 37167

Shopko Store Operating Co, LLC

www. shopko.com

For consumer questions

call 1-888-593-0593

Satisfaction 

SHOPKO

Guaranteed

435.000/435AA


Principal Display Panel



ShopKo

NDC 37012-435-43

COMPARE TO THE

INGREDIENTS OF LISTERINE

Glowing

White

Anticavity Mouthrinse

Fresh Mint

Begins working on contact

5 days to whiter teeth

Helps strengthen teeth

Kills germs that cause bad breath

Sealed With Printed Neckband For Your Protection

IMPORTANT: read directions for proper use.

16 fl oz (474 mL)


* Please review the disclaimer below.