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  5. Label Information: Antiseptic Mouth Rinse

FDA Label for Antiseptic Mouth Rinse

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. DO NOT USE
    6. STOP USE AND ASK A DENTIST
    7. KEEP OUT OF REACH OF CHRILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. DISCLAIMER
    12. CLAIMS
    13. ADVERSE REACTION
    14. PRINCIPAL DISPLAY PANEL

Antiseptic Mouth Rinse Product Label

The following document was submitted to the FDA by the labeler of this product Harris Teeter. 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 Ingredients



Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%


Purpose



Antigingivitis, Antiplaque


Use



helps control plaque that leads to gingivitis


Warnings



For this product


Do Not Use



If you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.


Stop Use And Ask A Dentist



if gingivitis, bleeding, or redness persists for more than 2 weeks


Keep Out Of Reach Of Chrildren.



If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Directions



adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day for 30 seconds then spit out; do not swallow

children under 12 years of age - consult a dentist or doctor

  • This rinse is not intended to replace brushing or flossing

Other Information



cold weather may cloud this product.  Its antiseptic properties are not affected.  Store at room temperature (59°-77°F).


Inactive Ingredients



water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel


Disclaimer



*This product is not manufactued or distributed by Johnson & Johnson Healthcare Products, distributor of Original Listerine.


Claims



ADA Accepted

American Dental Association

  • Helps reduce plaque
  • Helps reduce gingivitis

Adverse Reaction



PROUDLY DISTRIBUTED BY:

HARRIS TEETER, LLC, MATTHEWS, NC 28105

1-800-432-6111 or harristeeter.com


Principal Display Panel



Sealed witth printed neeckband for your protection

Harris Teeter

Compare to Original Listerine ® Antiseptic

ORIGINAL

ANTISEPTIC

MOUTH RINSE

ANTIGINGIVITIS/ANTIPLAQUE

* Please review the disclaimer below.