FDA Label for Alcohol Free Antiseptic

View Indications, Usage & Precautions

Alcohol Free Antiseptic Product Label

The following document was submitted to the FDA by the labeler of this product Kroger Co. 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



Kroger

FROM OUR FAMILY TO YOURS

Mint

ALCOHOL-FREE

ANTISEPTIC RINSE

ANTIGINGIVITIS/ANTIPLAQUE

MOUTH RINSE


Active Ingredient



Cetylpyrdinium 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 gum line, loose teeth or increased spacing between the teeth. These may be sings 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


Questions



Call 1-800-632-6900


Safety Information



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


Adverse Reactions Section



DISTRIBUTED BY

THEKROGER CO

CINCINNATI, OH 45202

www.kroger.com


Disclaimer



Crest Pro-Health Rinse is a registered trademark of The Procter & Gamble Company, Cincinnati, Ohio 45202.  The Procter & Gamble Company is not affilitated with The Kroger Co. or this product.


Principal Display



Kroger
ALCOHOL FREE
ANTISEPTIC
mouth
rinse
Antigingivitis/Antiplaque
Kills germs
Helps prevent plaque
Helps keep teeth feeling clean
Freshens breath
No burn of alcohol

mint

33.8 FL OZ (1 L)


* Please review the disclaimer below.