P-078 - Review of OTC Topical Analgesics for the Treatment of Minor Acute Pain Conditions

Abstract Title: Review of OTC Topical Analgesics for the Treatment of Minor Acute Pain Conditions

Background: Selecting the appropriate analgesic to manage a patient’s acute pain is a common challenge for healthcare professionals (HCPs). Topical analgesics are an attractive alternative to oral pain medications, providing targeted relief with limited systemic exposure. There has been a rapid growth in the over-the-counter (OTC) topical analgesic category in recent years, including single-ingredient and combination products available in formats such as creams, gels, and transdermal patches. Active ingredients commonly used in OTC topical analgesics include counterirritants and topical anesthetics, which are regulated through the FDA Monograph for External Analgesic Products for Over-the-Counter Human Use.

Purpose/Objectives: The focus of our research is to provide a comprehensive review of the most common topical analgesic actives in the US market, including mechanisms of action, existing clinical evidence to support their efficacy and safety, and their positioning in expert guidelines for treating acute pain conditions.


Methods: A literature review through December 31, 2023, was conducted to identify clinical evidence for efficacy and safety of common counterirritant and topical anesthetic actives, alone or in combination, found in the US market. The search included the counterirritants methyl salicylate, turpentine oil, camphor, eucalyptus, menthol, and capsaicin, as well as the topical anesthetics (amides or “-caines”) lidocaine, benzocaine, and tetracaine.

Results: Counterirritants are topically applied drugs that cause irritation or mild inflammation of the skin in one area of the body while reducing pain in another area, which occurs through activation and subsequent desensitization of cutaneous nerves. The most common counterirritant products in US formulations include methyl salicylate and turpentine oil (producing skin redness), menthol and camphor (cooling sensation), and capsaicin (mild irritation without redness). Counterirritants are indicated for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. Local anesthetics such as lidocaine, benzocaine and tetracaine, relieve pain by depressing cutaneous sensory receptors and are indicated for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

Conclusions/Implications for future research and/or clinical care: Topical analgesic products using counterirritant and/or local anesthetic ingredients offer an alternative to oral medicines for the treatment of mild pain resulting from common acute conditions. They provide effective, targeted relief with good safety profiles and are an attractive option for patients unable to tolerate oral analgesics. This review provides a comprehensive guide for these products to support HCPs in their use.


References: < !1. Final Administrative Order OTC000033_M017-External Analgesic Drug Products for OTC Human Use.pdf (fda.gov)


< !2. Garg V, et al. Counterirritants and Sensory Profiling of Pain-Relieving Patches. International Journal of Pharmaceutical and Bio-Medical Science. 2022;2(11):466-478

< !3. Barkin RL. The Pharmacolody of Topical Analgesics. Postgrad Med. 2013;125(4):7-18.

< !4. Mason L, et al. Systematic review of efficacy of topical rubefacients containing salicylates for the treatment of acute and chronic pain. BMJ. 2004;328(7446):995.

< !5. Page P & Alexander L. The clinical effectiveness of Biofreeze topical analgesic on musculoskeletal pain: a systemic review. J Perform Health Res. 2017;1.

< !6. Sundstrup E, et al. Acute effect of topical menthol on chronic pain in slaughterhouse workers with carpal tunnel syndrome: triple-blind, randomized placebo-controlled trial. Rehabil Res ract, 2014; p. 310913

< !7. Gudin JA, et al. Inprovement of Pain and Function After Use of a Toical Pain Relieving Patch: Results of the RELIEF Study. J Pain Res, 2020;13:1557-1568.

< !8. Mason L, et al. Systematic review of topical capsaicin for the treatment of chronic pain. BMJ, 2004;328(7446):991.

< !9. Zhang WY & Po ALW. The effectiveness of topically applied capsaicin. A meta-analysis. Eur J Clin Pharmacol, 1994;46(6):517-22

< !10. Kalajian TA, et al. An overview of local anesthetics in over-the-counter products. Pain Practice. 2024;24:364-373.

< !11. Castro E & Dent D. A comparison of transdermal over-the-counter lidocaine 3.6% menthol 1.25%, Rx lidocaine 5% and placebo for back pain and arthritis. Pain Management. 2017;7(6):489-98.