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 Liberty Procurement, Inc. 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.

Claims



COREVLAUES

Antiseptic

MOUTHWASH

ANTIGINGIVITIS/ANTIPLAQUE ORAL RINSE

MULTI-ACTION


Active Ingredient



Cetylpyridinium chloride 0.07%


Purpose



Antigingivitis, Antiplaque


Use



helps control plaque that leads to gingivitis


Warnings



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 20mL (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


Safety Information



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


Disclaimer



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


Adverse Reactions



Distributed by

Liberty Procurement, Inc.

650 Liberty Ave.

Union, NJ 07083 USA

Visit us at www.facevalues.com

299.005/299AK


Principal Display Panel



SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ALCOHOL

FREE

COREVALUES

Compare to Crest Pro-Health Clean Mint

Antiseptic

MOUTHWASH

ANTIGINGIVITIS/ANTIPLAQUE ORAL RINSE

MULTI-ACTION

  • Kills germs
  • Helps prevent plaque
  • Helps prevent gingivits
  • Freshens breath
  • Zesty Mint

    1 L (33.8 FL OZ)


* Please review the disclaimer below.