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Methyl salicylate and menthol: Drug information

Methyl salicylate and menthol: Drug information
(For additional information see "Methyl salicylate and menthol: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • AMPlify Relief MM [OTC];
  • Analgesic Balm [OTC];
  • Asperflex [OTC];
  • BenGay [OTC];
  • Calypxo HP [OTC];
  • Capasil [OTC];
  • Castiva [OTC];
  • Dynarub [OTC];
  • Exigence [OTC];
  • Icy Hot [OTC];
  • Kwan Loong Pain Relieving [OTC];
  • Mencylate [OTC];
  • Muscle Rub [OTC];
  • Precise [OTC];
  • Salonpas Arthritis Pain [OTC];
  • Salonpas Jet Spray [OTC];
  • Salonpas Massage Foam [OTC];
  • Salonpas Pain Relief Patch [OTC];
  • Thera-Gesic Plus [OTC] [DSC];
  • Thera-Gesic [OTC];
  • Xoten [OTC]
Pharmacologic Category
  • Analgesic, Topical;
  • Salicylate;
  • Topical Skin Product
Dosing: Adult
Pain relief

Pain relief: Topical:

Balm, cream, foam, spray, stick: Apply to affected area; may repeat up to 3 to 4 times/day.

Patch:

Methyl salicylate 10% and menthol 1.5%: Apply 1 patch to affected area not more than 3 to 4 times daily; leave in place for no more than 8 hours.

Methyl salicylate 10% and menthol 3%: Apply 1 patch to affected area and leave in place for up to 8 to 12 hours; do not exceed 1 patch/application. If pain still present, a second patch may be applied for up to 8 to 12 hours (maximum: 2 patches per 24 hours; 3 days of consecutive use).

Dosing: Pediatric
Pain relief

Pain relief: Topical:

Balm, cream, foam, spray, stick: Children ≥12 years: Refer to adult dosing.

Patch: Methyl salicylate 10% and menthol 1.5%: Children ≥12 years: Refer to adult dosing.

Adverse Reactions

There are no adverse reactions listed in the manufacturer's labeling.

Postmarketing: Dermatologic: Burn (chemical) (Desai 2021)

Contraindications

Hypersensitivity to menthol, methyl salicylate, aspirin, nonsteroidal anti-inflammatory drugs, other salicylates, or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Burns: May cause serious burns (eg, first- to third-degree chemical burns) at the application site. In some cases, hospitalization has been required. Discontinue use and seek medical attention if signs of skin injury (eg, pain, swelling, or blistering) occur following application (FDA Drug Safety Communication, 2012).

Dosage form specific issues:

• Cream: Avoid exposing application site to heat or direct sunlight.

• Topical patch: Self-medication (OTC use): Prior to self-medication, patients should be instructed to contact a healthcare provider if they have had recurring stomach pain or upset, ulcers, bleeding problems, high blood pressure, heart or kidney disease, other serious medical problems, are currently taking a diuretic, anticoagulant, other NSAIDs, or are ≥60 years of age. Recommended dosages and duration should not be exceeded, due to an increased risk of GI bleeding, MI, and stroke. Patients should stop use and consult a healthcare provider if symptoms get worse, newly appear, or persist for >3 days; if rash, itching, or excessive skin irritation occurs, or if an allergic reaction occurs; if feeling faint, vomit blood or have bloody/black stools. Consuming ≥3 alcoholic beverages/day or taking longer than recommended may increase the risk of GI bleeding. Patch is for external use only and should not be applied to wounds or damaged skin; do not use concurrently with other topical analgesics. May contain conducting metal (eg, aluminum); remove patch prior to MRI.

Other warnings/precautions:

• Self-medication (OTC use): When used for self-medication, discontinue use and contact health care provider if symptoms persist >7 days, condition worsens or recurs, or if rash, irritation, itching, or skin injury (eg, pain, swelling, blistering) develops. Do not use on open wounds, cuts, damaged or infected skin; in the eyes, mouth, genitals; or any other mucous membranes.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Aerosol, foam, topical:

Salonpas Massage Foam: Methyl salicylate 10% and menthol 3% (118 mL)

Aerosol, spray, topical:

Salonpas Jet Spray: Methyl salicylate 10% and menthol 3% (118 mL) [contains ethanol]

Balm, topical:

Icy Hot Balm: Methyl salicylate 29% and menthol 7.6% (99.2 g)

Cream, topical:

AMPlify Relief MM: Methyl salicylate 30% and menthol 10% (118 g)

Analgesic Balm: Methyl salicylate 15% and menthol 10% (28 g, 85 g)

Asperflex: Methyl salicylate 15% and menthol 10% (85 g)

BenGay Arthritis Formula: Methyl salicylate 30% and menthol 8% (57 g, 113 g)

BenGay Greaseless: Methyl salicylate 15% and menthol 10% (57 g, 113 g [DSC])

Calypxo HP: Methyl salicylate 15% and menthol 10% (113 g) [contains cetyl alcohol]

Capasil: Methyl salicylate 10% and menthol 2% (59 mL) [contains cetearyl alcohol, cetyl alcohol, edetate trisodium, proplylene glycol]

Dynarub: Methyl salicylate 15% and menthol 10% (84.7 g) [contains cetyl alcohol]

Icy Hot: Methyl salicylate 30% and menthol 10% (35.4 g, 85 g)

Mencylate: Methyl salicylate 10% and menthol 2% (59 mL)

Muscle Rub: Methyl salicylate 15% and menthol 10% (85g)

Precise: Methyl salicylate 30% and menthol 10% (75 g)

Thera-Gesic: Methyl salicylate 15% and menthol 1% (85 g, 142 g)

Thera-Gesic Plus: Methyl salicylate 25% and menthol 4% (85 g [DSC]) [contains aloe]

Lotion, topical:

Castiva: Methyl salicylate 14% and menthol 5% (113 g)

Exigence: Methyl salicylate 10% and menthol 3% (113 g) [contains cetyl alcohol]

Xoten: Methyl salicylate 6.25% and menthol 12.5% (120 mL)

Oil, topical:

Kwan Loong Pain Relieving: Methyl salicylate 35% and menthol 16% (57 mL)

Patch, topical:

Salonpas Arthritis Pain®: Methyl salicylate 10% and menthol 3% (5s)

Salonpas Pain Relief Patch®: Methyl salicylate 10% and menthol 1.5% (3s)

Salonpas Pain Relief Patch®: Methyl salicylate 10% and menthol 3% (5s)

Stick, topical:

Icy Hot: Methyl salicylate 30% and menthol 10% (49 g)

Generic Equivalent Available: US

No

Pricing: US

Cream (Asperflex External)

10-15% (per gram): $0.04

Cream (Capasil External)

2-10% (per mL): $8.44

Cream (Dynarub External)

10-15% (per gram): $0.03

Cream (Mencylate External)

2-10% (per mL): $25.40

Cream (Thera-Gesic External)

1-15% (per gram): $0.06

Lotion (Castiva Cooling External)

5-14% (per gram): $0.11

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Apply topically; for external use only. Do not apply to wounds, rashes, damaged skin, mucous membranes, or right after bathing. Wash area where applied prior to bandaging, covering, or wrapping; do not bandage tightly. Do not use a heating pad after application or expose treated area to heat or direct sunlight. Do not use cream or balm concurrently with a medicated patch.

Topical patch: Apply patch externally to clean and dry affected area. Backing film should be removed prior to application. Patch should not be applied to face. Wash hands before and after application.

Administration: Pediatric

Topical: For external use only. Avoid contact with eyes and mucous membranes. Apply to clean and dry affected area. Do not apply to wounds, rashes, or damaged skin. Do not apply right after bathing/showering or use a heating pad after application.

Foam: Shake can well prior to use. Do not use upside down. Avoid inhalation. Spray foam onto fingers or palm for no longer than 3 seconds; massage well into the affected area until the crackling sound stops.

Spray: Shake can well prior to use. Avoid inhalation. To avoid frostbite, hold can 4 inches away from skin and spray affected area(s) no longer than 1 second.

Topical patch: Apply patch externally to clean and dry affected area. Backing film should be removed prior to application. Patch should not be applied to face. Wash hands before and after application.

Use: Labeled Indications

Pain relief: Temporary relief of minor aches and pains of muscle and joints associated with arthritis, bruises, simple backache, cramps, sprains, and strains.

Medication Safety Issues
Pediatric patients: High-risk medication:

KIDs List: Salicylates, when used in pediatric patients <18 years of age with suspicion of viral illness (influenza, chickenpox), are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list and should be used with caution due to risk of Reye syndrome (weak recommendation; very low quality of evidence) (PPA [Meyers 2020]).

Other safety concerns:

Transdermal patch may contain conducting metal (eg, aluminum); remove patch prior to MRI.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Warfarin: Salicylates (Topical) may enhance the anticoagulant effect of Warfarin. Risk C: Monitor therapy

Pregnancy Considerations

Maternal use of methyl salicylate should be avoided beginning at 20 weeks' gestation.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Salonpas;
  • (AR) Argentina: Atomo desinflamante forte | Bengue desinflamante;
  • (AU) Australia: Deep Heat Regular Rub;
  • (BD) Bangladesh: Bangay | Icykool | Koolmint | P cool | Penrif | Salirub | Xenthol;
  • (BR) Brazil: Balsamo bengue | Rubidex;
  • (CN) China: Compound methyl salicylate;
  • (CO) Colombia: Atletic's | Ben gay | Dolotrin gel | Forz sport | Xray aliv;
  • (EC) Ecuador: Ben gay para deportistas | Dologel | Icy hot;
  • (EE) Estonia: Ben gay;
  • (EG) Egypt: Ben gay | Bengay | Menthogreen;
  • (ET) Ethiopia: Menzza;
  • (HK) Hong Kong: Deep heat | Eckerd muscle rub | Mesalic;
  • (ID) Indonesia: Konibalm | Salonpas | Zeropain;
  • (IN) India: Muslax;
  • (JP) Japan: Ben gay | Rub rohto | Salonpas;
  • (KE) Kenya: Tiger balm liniment;
  • (KR) Korea, Republic of: Antiphlamine S | Menssoltech | Mentham neo | Menthom neo | Moolpap | Moolpop;
  • (KW) Kuwait: Deep heat | Deep heat max strength;
  • (LT) Lithuania: Ben gay;
  • (LV) Latvia: Ben gay | Bengay Greaseless | Deep heat;
  • (MX) Mexico: Bengue pm | Icy hot | Termo rub forte | Termorub;
  • (MY) Malaysia: Antiphlamine S;
  • (NG) Nigeria: Klusyl;
  • (PE) Peru: Amerin hot | Icy hot;
  • (PH) Philippines: Alaxan;
  • (PR) Puerto Rico: Analgesic | Arthritis hot | Bengay Greaseless Pain Relieving | Icy hot | Muscle rub | Pain bust r ii | Pain relieving rub | Precise | Thera gesic;
  • (PY) Paraguay: Bengue desinflamante | Mentholatum calorub | Mentovick rub;
  • (QA) Qatar: Salonpas;
  • (RO) Romania: Ben gay greaseless;
  • (RU) Russian Federation: Bengay | Bengay sport;
  • (SA) Saudi Arabia: Comfort | Salonpas;
  • (SG) Singapore: Antiphalamine s | Menzza | Salonpas;
  • (TH) Thailand: Fasgesic | N.l. gesic | Salonpas;
  • (TW) Taiwan: Musaid a | Salonpas;
  • (UA) Ukraine: Ben gay sport balm | Bengay;
  • (VE) Venezuela, Bolivarian Republic of: Fricsol;
  • (VN) Viet Nam: Methocylat
  1. Arthritis Hot (methyl salicylate/menthol) [prescribing information]. Chattanooga, TN: Chattem Inc; received October 2018.
  2. Desai R, Gutierrez J, Cherukuri SV, Guzman J, Deoker A. From chemical burn to below knee amputation: amputation secondary to application of over-the-counter topical analgesic with menthol and methyl salicylate. Cureus. 2021;13(12):e20191. doi:10.7759/cureus.20191 [PubMed 35004014]
  3. Food and Drug Administration (FDA) Drug Safety Communication, "Rare Cases of Serious Burns With the Use of Over-the-Counter Topical Muscle and Joint Pain Relievers," 2012. Available at http://www.fda.gov/Drugs/DrugSafety/ucm318858.htm
  4. Icy Hot (methyl salicylate/menthol) [prescribing information]. Chattanooga, TN: Chattem Inc; received February 2020.
  5. Icy Hot Extra Strength balm (methyl salicylate/menthol) [prescribing information]. Chattanooga, TN: Chattem Inc; received February 2020.
  6. Icy Hot Extra Strength cream (methyl salicylate/menthol) [prescribing information]. Chattanooga, TN: Chattem Inc; received February 2020.
  7. Meyers RS, Thackray J, Matson KL, et al. Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List. J Pediatr Pharmacol Ther. 2020;25(3):175-191. [PubMed 32265601]
  8. Salonpas Pain Relief Patch (methyl salicylate/menthol) [prescribing information]. Florham Park, NJ: Hisamitsu America Inc; received November 2021.
  9. Thera-Gesic (methyl salicylate/menthol) [prescribing information]. San Antonio, TX: Mission Pharmacal; received April 2017.
Topic 9504 Version 124.0

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