Multi-action Antiseptic Rinse
FDA Label NDC 72288-299

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amazon.com Services Llc for the product Multi-action Antiseptic (NDC 72288-299). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding claims, active ingredients, purpose, use, warnings, stop use and ask a dentist if, keep out of reach of children under 6 years of age., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Claims

For better oral hygiene

and fresher breath

Active Ingredients

Cetylpyridinium Chloride 0.07%

Purpose

Antigingivitis, Antiplaque

Use

helps control plaque that leads to gingivitis

Warnings

for this product

Stop Use And Ask A Dentist If

  • gingivitis, bleeding or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gun line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep Out Of Reach Of Children Under 6 Years Of Age.

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

Directions

  • adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  • children 6 years to under 12 years of age: supervise use
  • when used after brushng, rinse mouth with water first
  • children under 6 years of age: do not use

Other Information

  • this rinse is not intended to replace brushing or flossing

Inactive Ingredients

water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

Disclaimer

This rinse may cause temporary staining to the sufrace of teeth. This is not harmful and adequate brushing may prevent its occurrence.

Adverse Reactions

DISTRIBUTED BY:

Amazon.com Services, Inc

Seattle, WA 98109

1-877-485-0385

2018 Amazon.com, Inc or its Affiliates.  All rights reserved.  Solimo and all related logos are trademarks of Amazon.com, Inc or its affiliates.

Principal Display Panel

Solimo

Multi Action

Antiseptic Rinse

ANTIGINGIVITIS/ANTIPLAQUE

MOUTH RINSE

Fresh mint

Alcohol free

1 L (33.8 FL OZ)

Image Description (Mm3)

Image Description (Mm3)

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