FDA Label for Antiseptic Mouth Rinse

View Indications, Usage & Precautions

Antiseptic Mouth Rinse Product Label

The following document was submitted to the FDA by the labeler of this product Walgreens Co.. 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.



Of 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.  It antiseptic properties are not affected.  Store at room temperature (59⁰ - 77⁰ F)


Inactive Ingredients



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


Other



The ADA Council on Scientific  Affairs Acceptance of  Wallgreens Spring Mint Antiseptic Mouth Rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed.

This product is not manufactured or distributed by Johnson + Johnson Healthcare products, distributor of Listerine Fresh Burst

DSP-TN-1500  DSP-MO-34  SDS-TN-15012


Principal Display Panel



WELL at Walgreens

ANTISEPTIC Mouth Rinse

  • Freshens breath
  • Improves oral hygiene
  • Alcohol 21.6%
  • ADA Accepted American Dental Association

    Spring Mint

    Compare to Listerine Fresh Burst Active ingredients

    16.9 FL OZ (500 mL)

    072.002/072AL


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