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LISTERINE® Brand Rinses: Safety and Tolerability

LISTERINE® Brand Rinses: Safety and Tolerability

LISTERINE® Antiseptic is the most extensively studied and tested mouthwash in the world, with over 30 long-term clinical trials examining its safety and effiicacy.42

Alcohol-containing rinses have no causal link to oral dryness

In clinical trials:

  • Safe for xerostomic patients23
  • Does not promote oral dryness23-25

Fischman, et al. American Journal of Dentistry 2004;17(1):23-2623

  • 14 days of exaggerated use (3x per day; more than recommended dose) by subjects xerostomic as a result of Sjogren’s syndrome
  • Finding: Favorable tolerability, no drying of oral mucosa, and no decreased salivary flow rates 

Kerr, et al. Quintessance International 2007;38(8):41-4824

  • 2-week randomized, crossover pilot studying the use of alcohol and non-alcohol-containing mouthrinses in healthy adults
  • Finding: No significant differences in salivary flow rates or patient-reported sensations of dry mouth between alcohol and non-alcohol-containing mouthrinse groups 

Kerr, et al. Journal of Dental Research 2011;90 (Special Issue A): Abstract25

  • 3 month clinical study comparing two mouthrinses on salivary flow and perceived dryness
  • Finding: Alcohol-based essential oil mouthrinse no more likely to cause a reduction in salivary flow or perceived dryness than a non-alcohol-based cetyl pyridinium chloride (CPC) mouthrinse

Alcohol-containing rinses have no link to oral cancer

In clinical trials:

  • No credible link to oral cancer26-29
  • LISTERINE® Antiseptic is the most extensively tested mouthwash in the world, with over 30 long-term clinical trials examining its safety and efficacy42

Food and Drug Administration. 2003 Federal Register 2003; 68(103):32232-3228726

  • FDA subcommittee reviewed 7 case-control studies
  • Conclusion: “Data do not support a causal relationship between the use of alcohol-containing mouthrinses and oral cancer. The vote was unanimous…”

Cole, et al. Journal of the American Dental Association 2003; 34(8):1079-108727

  • Review of 9 case-control studies, published in JADA
  • Finding: alcohol-containing mouthwash does not increase risk of oropharyngeal cancer
  • “…the weight of the evidence strongly suggests that use of alcohol-containing mouthrinse (ACM) does not increase the risk of OPC. Practicing dentists may recommend to their patients that they use the mouthwashes of their choice, including those that contain alcohol.”

La Vecchia, et al. Oral Oncology 2009;45:198-20028

  • Critical review of published data
  • Finding: Link between mouthwash use (specifically alcohol-containing mouthwash) and oral cancer is not supported by epidemiological evidence
  • “The pattern of risk is not different with reference to alcohol-containing mouthwashes, and other types of mixed use of mouthwashes. This, again, weighs against any relevant association between alcohol-containing mouthwashes and oral cancer risk.”

Boyle, et al. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology 2011; 112;(6):e13029

  • Finding: No association between use of mouthwash containing alcohol and oral cancer risk
  • “This quantitative analysis of all published epidemiologic studies of mouthwash use and oral malignancy revealed (1) no statistically significant association between mouthwash use and risk of oral cancer, including no significant trend in risk with increasing daily use; and (2) no association between use of mouthwash containing alcohol and oral cancer risk.”
3 Essential Oils

The fixed combination deeply penetrates plaque biofilm, killing bacteria and inhibiting growth

Scientific innovation

Even though alcohol is an inactive ingredient, it plays two very important roles that contribute to the effectiveness of LISTERINE® Antiseptic rinses.