FDA Label for Antiseptic Mouthrinse

View Indications, Usage & Precautions

Antiseptic Mouthrinse Product Label

The following document was submitted to the FDA by the labeler of this product Amazon.com Services 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 sailcylate 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 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


Other



Sealed with printed neckband for your protection

DISTRIBUTED BY:

Amazon.com, Services, Inc

Seattle, WA 98109

1-877-485-0385

2018 Amazon.com, Inc. or its afiliates.

All rights reserved. Solimo and all related logos are are trademarks of Amazon.com, Inc or its affiliates.

DSP-TN-15000

DSP-MO-34

SDS-TN-15012   

072.003/072AL rev 2


Principal Display Panel



SOLIMO

Antiseptic Mouthwash

Antigingivitis/Antiplaque

Freshenng mint flavor

1 L (33.8 FL OZ)


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