FDA Label for Antigingivitis/antiplaque

View Indications, Usage & Precautions

Antigingivitis/antiplaque 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.

Tamper Evident Statement



SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION


Claims & Disclaimer



QUALITY GUARANTEED

This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence.

*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest ®Pro-Health ®Intense Clean Mint Mouthwash.

**Kills at least 99% of many organisims commonly associated with bad breath in as little as 15 seconds.


Active Ingredient



Cetylpyridinium Chloride 0.05%


Purpose



Antigingivitis, Antiplaque


Use



helps control plaque that leads to gingivitis


Warnings



for this product


Stop Use And Ask A Dentist If



  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep Out Of Reach Of Children Under 6 Years Of Age.



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 & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  • children 6 years to under 12 years of age: supervise use
  • when used after brushing, rinse mouth with water first
  • children under 6 years of age: do not use

Other Information



  • this rinse is not intended to replace brushing or flossing

Inactive Ingredients



water, alcohol (15 wt%), propylene glycol, flavor, poloxamer 407, sucralose, benzoic acid, sodium benzoate, cinnamal, blue 1, yellow 6


Questions?



Call 1-888-423-0139


Adverse Reaction



DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143

©TOPCO VIJA1123   QUESTIONS? 1-888-423-0139

[email protected]    www.topcarebrands.com

Scan here for more information or call 1-888-423-0139


Principal Panel Display



COMPARE TO CREST® PRO-HEALTH® INTENSE CLEAN MINT MOUTHWASH*

TopCare ® everyday

Powerful Fresh

Antigingivitis/Antiplaque

Mouthwash

FRESH MINT

Kills 99% of many bad breath germs**

Freshens your breath

Helps prevent plaque and gingivitis

IMPORTANT: Read directions for proper use.

1 L (1.5 QT) 33.8 FL OZ


* Please review the disclaimer below.