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  5. Label Information: Antiseptic Mouthrinse

FDA Label for Antiseptic Mouthrinse

View Indications, Usage & Precautions

Table of Contents

    1. TEP
    2. ACTIVE INGREDIENTS
    3. PURPOSE
    4. USE
    5. WARNINGS
    6. DO NOT USE IF
    7. STOP USE AND ASK A DENTIST IF
    8. KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. ADA COUNCIL STATEMENT
    13. SATISFACTION GUARANTEED
    14. ADVERSE REACTIONS SECTION
    15. PRINCIPAL DISPLAY PANEL

Antiseptic Mouthrinse Product Label

The following document was submitted to the FDA by the labeler of this product Wal-mart Stores, 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.

Tep



Sealed with printed neckband for your protection


Active Ingredients



Eucalyptol 0.092%, Menthol 0.042%, Methyl sailcylate 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 incresed 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 rednss persists for more than 2 weeks


Keep Out Of Reach Of Children



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


Directions



adults and children under 12 years if age and older - vigorously swish 20 ml (2/3 FL OZ or 4 teaspoonfuls) between teeth 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 propeties are not affected.  Store at room temperature (59° -77° F)


Inactive Ingredients



water, alcohol 21.6 %, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no. 10, FD&C green no.3


Ada Council Statement



"The ADA Council on Scientific Affairs'  Acceptance of Equate Spring Mint Antiseptic Mouthrinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gum Line, when used as directed."


Satisfaction Guaranteed



- Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.


Adverse Reactions Section



DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, owner of the registered mark FreshBurst Listerine


Principal Display Panel



equate

Compare to FreshBurst

Listerine

Active

Ingredients

Antiseptic

Mouthrinse

Kills Germs that Cause:

  • Plaque
  • Gingivitis
  • Bad breath

    • ADA

    Accepted

    American Dental Association

    Spring Mint

    Made in the

    USA

    with 90% OR MORE US PARTS

    Factory Certified

    1.5 LITERS (50.7 FL OZ)

    image description - mm3

    image description - mm3


* Please review the disclaimer below.