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Home>Clinical Evidence>Safety & Tolerability

Safe. Effective.

100% Bold.

Does LISTERINE® have side effects? With over 30 long-term clinical trials, LISTERINE® Antiseptic is the most extensively tested OTC mouthwash.1

SAFE FOR BOTH DAILY AND LONG-TERM USE

  • Does not promote oral dryness2-4
  • Does not disrupt the normal balance of oral flora3,4
  • No emergence of resistant strains, even with long-term use3,4
  • Does not promote significant tooth stain or calculus (tartar) formation5-8

ALCOHOL-CONTAINING RINSES HAVE NO CAUSAL LINK TO ORAL DRYNESS

In clinical trials:

  • Safe for xerostomic patients2
  • Favorable tolerability, no drying of oral mucosa, and no decreased salivary flow rates2
  • No significant differences in salivary flow rates or patient-reported sensations of dry mouth between alcohol and non-alcohol-containing mouthrinse groups3
  • Alcohol-based essential oil mouthrinse no more likely to cause a reduction in salivary flow or perceived dryness than a non-alcohol-based cetylpyridinium chloride (CPC) mouthrinse4

ALCOHOL-CONTAINING RINSES HAVE NO LINK TO ORAL CANCER

In clinical trials:

  • No credible link to oral cancer9-12
  • An FDA subcommittee reviewed 7 case-control studies and concluded: “Data do not support a causal relationship between the use of alcohol-containing mouthrinses and oral cancer. The vote was unanimous…”9
  • Alcohol-containing mouthwash does not increase risk of oropharyngeal cancer”10
  • Link between mouthwash use (specifically alcohol-containing mouthwash) and oral cancer is not supported by epidemiological evidence11
  • No association between use of mouthwash containing alcohol and oral cancer risk12

    *Based on self-reported data from a survey of patients in Brazil, Japan, Thailand, United Kingdom, and United States (N=4134).

    References: 1. Data on file, Johnson & Johnson Consumer Inc. 2. Fischman SL, Aguirre A, Charles CH. Use of essential oil-containing mouthrinses by xerostomic individuals: determination of potential for oral mucosal irritation. Am J Dent. 2004;17(1):23-26. 3. Kerr AR, Katz RW, Ship JA. A comparison of the effects of 2 commercially available nonprescription mouthrinses on salivary flow rates and xerostomia. Quintessence Int. 2007;38(8):e440-447. 4. Kerr AR, Corby PM, Kalliontzi K, McGuire JA, Charles CA. Comparison of two mouthrinses in relation to salivary flow and perceived dryness. Oral Surg Oral Med Oral Pathol Oral Radiol. 2015;119(1):59-64. 5. Overholser CD, Meiller TF, DePAola LG, Minah GE, Niehaus C. Comparative effects of 2 chemotherapeutic mouthrinses on the development of supragingival dental plaque and gingivitis. J Clin Periodontol. 1990;17(8):575-579. 6. DePaola LG, Overholser CD, Meiller TF, Minan GE, Niehaus C. Chemotherapeutic inhibition of supragingival dental plaque and gingivitis development. J Clin Periodontol. 1989;16(5):311-315. 7. Gordon JM, Lamster IB, Seiger MC. Efficacy of Listerine antiseptic in inhibiting the development of plaque and gingivitis. J Clin Periodontol. 1985;12(8):697-704. 8. Lamster IB, Alfano MC, Seiger MC, Gordon JM. The effect of Listerine antiseptic on reduction of existing plaque and gingivitis. Clin Prev Dent. 1983;5(6):12-16. 9. Food and Drug Administration. Oral health care drug products for over-the-counter human use; antigingivitis/antiplaque drug products; establishment of a monograph; proposed rules. Part III. Federal Register. 2003;68(103):32232-32287. 10. Cole P, Rodu B, Mathisen A. Alcohol-containing mouthwash and oropharyngeal cancer: a review of the epidemiology. J Am Dent Assoc. 2003;134(8):1079-1087. 11. La Vecchia C. Mouthwash and oral cancer risk: an update. Oral Oncol. 2009;45(3):198-200. 12. Boyle P, Gandini S, Boffetta P, Negri E, La Vecchia C. Mouthwash use and oral cancer risk: quantitative meta-analysis of epidemiologic studies. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011;112(6):e130.

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