FDA Label for Antiseptic

View Indications, Usage & Precautions

Antiseptic Product Label

The following document was submitted to the FDA by the labeler of this product Consumer Product Partners, 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



Cetylpyridinium chloride 0.07%


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 gun 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, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1


Disclaimer



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

*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health® Multi-Protection Alcohol Free Rinse Refreshing Clean Mint.


Claims



**killed at least 99% of organisms commonly associated with gingivitis in as little as 15 seconds.


Tamper Evident Statement



SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION


Adverse Reactions



Distributed by:

Consumer Product Partners, LLC 

St. Louis, MO 63114

1-888-593-0593


Principal Display Panel



Swan ®

COMPARE TO Crest ® Pro Health ®*

$1.25

MULTI-ACTION MOUTHWASH

ANTIGINGIVITIS/ANTIPLAQUE

ZESTY MINT

  • kills 99% of germs for a healther mouth**
  • Helps fight gingivitis 
  • Freshens breath
  • Alcohol free
  • 500 mL (1.05 PT) 16.9 FL OZ


* Please review the disclaimer below.