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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 IF
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. OTHER
    12. PRINCIPAL DISPLAY PANEL

Antiseptic Mouth Rinse Product Label

The following document was submitted to the FDA by the labeler of this product Marc Glassman, 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.

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



Warnings


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 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 12 years of 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 properties are not affected.  Store at room temperature (59⁰ - 77⁰F)


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


Other



*This product is not manufactured or distributed by Johnson & Johnson Healthcare products, distributor of FreshBurst® Listerine® Antiseptic Mouthwash.

Distributed by:

Marc Glassman, Inc

West 130th Street

Cleveland, OH 44130

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

072.002/072AL


Principal Display Panel



*Compare to FreshBurst® Listerine® Mouthwash

Marc's

Antiseptic Mouthwash

HELPS REDUCE PLAQUE AND REFRESH BREATH

Kills Germs that Cause

* Please review the disclaimer below.