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  5. Label Information: Antiseptic

FDA Label for Antiseptic

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. ADVERSE REACTIONS
    12. PRINCIPAL DISPLAY PANEL

Antiseptic 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.

Active Ingredient



Cetylpyridinium chloride 0.07%


Purpose



Antigingivitis, Antiplaque


Use



helps control plaque that leads to gingivitis


Warnings



for this product only


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
  • 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 product is not manufactured or distributed by
Procter & Gamble distributor of Crest Pro-Health Rinse


Adverse Reactions



DISTRIBUTED BY TOPCO ASSOCIATES, LLC
ELK GROOVE VILLAGE, IL 60077
QUESTIONS? 1-888-423-0139
[email protected]


Principal Display Panel



Sealed With Printed Neckband For Your Protection

TopCare

ALCOHOL

FREE

Oral

Health

Rinse

ANTISEPTIC

Antigingivitis/Antiplaque

  • Kills germs
  • Helps prevent plaque
  • Helps prevent gingivitis
  • Helps keep teeth feeling clean
  • No burn of alcohol
  • Freshens breath

    • Mint Flavor

    QUALITY

    GUARANTED

    COMPARE TO ACTIVE INGREDIENT

    OF CREST PRO-HEALTH RINSE

    33.8 FL OZ

    (1 QT 1.8 FL OZ) 1 L

    image description - mm3

    image description - mm3


* Please review the disclaimer below.