FDA Label for Antispetic

View Indications, Usage & Precautions

Antispetic 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 Ingredients



Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%


Purpose



Antigingivitis, antiplaque


Use



help control plaque that leads to gingivitis


Warnings



For this product


Do Not Use



If you have painful or swollem 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 the rinse

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 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sucralose and/or sodium saccharin, sodium benzoate, propylene glycol alginate, FD&C yellow no. 6, FD&C blue no. 1


Other



DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007

TOPCO VIJ315 Questions? 1-888-423-0139 topcare @topco.com www.topcarebrand.com

124.000/124AE


Principal Display Panel



TopCare everyday

Antiseptic Mouth Rinse

VANILLA MINT

Antigingivitis/Antiplaque

Kills germs that cause plaque, gingivitis and bad breath

Sealed With Printed Neckband For Your Protection

1 L (1 QT 1.8 FL OZ) 33.8 FL OZ


* Please review the disclaimer below.