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  5. Label Information: Antigingivitis/antiplaque

FDA Label for Antigingivitis/antiplaque

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. STOP USE AND ASK A DENTIST IF
    6. KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OF AGE.
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. DISCLAIMER
    11. TAMPER EVIDENT STATEMENT
    12. ADVERSE REACTION
    13. PRINCIPAL DISPLAY PANEL

Antigingivitis/antiplaque 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 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, glycerin, flavor, zinc lactate, benzoic acid, sodium saccharin, sucralose, sodium benzoate, poloxamer 407, cinnamal, blue 1


Disclaimer



This 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 ®CPC Antiginigivitis/Antiplaque Oral Rinse Gum and Breath Purify Smooth Mint.


Tamper Evident Statement



SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION


Adverse Reaction



Distributed by:

Consuemr Product Partners, LLC

St. Louis, MO 63114

1-888-593-0593


Principal Display Panel



SWAN ®

COMPARE TO Crest ® Pro Health ®*

$1.25

GUM DEFENSE MOUTHWASH

ANTIGINGIVITIS/ANTIPLAQUE

SMOOTH MINT

  • Helps reduce early signs of gum disease
  • Kills the germs that cause bad breath
  • Alcohol free

    • 500 mL (1.05 PT) 16.9 FL OZ

    image description - mm01

    image description - mm01


* Please review the disclaimer below.