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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

MENTHOL: 1,504 Adverse Event Reports & Safety Profile

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1,504
Total FAERS Reports
212 (14.1%)
Deaths Reported
104
Hospitalizations
1,504
As Primary/Secondary Suspect
27
Life-Threatening
407
Disabilities
McKesson
Manufacturer

Route: ORAL · Manufacturer: McKesson · HUMAN OTC DRUG · FDA Label: Available

First Report: 19320101 · Latest Report: 20250820

What Are the Most Common MENTHOL Side Effects?

#1 Most Reported
Exposure to chemical pollution
492 reports (32.7%)
#2 Most Reported
Mesothelioma
269 reports (17.9%)
#3 Most Reported
Drug ineffective
207 reports (13.8%)

All MENTHOL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Exposure to chemical pollution 492 32.7% 160 16
Mesothelioma 269 17.9% 92 4
Drug ineffective 207 13.8% 23 24
No adverse event 161 10.7% 0 0
Occupational exposure to toxic agent 160 10.6% 41 4
Pain 158 10.5% 44 8
Application site pain 103 6.9% 0 7
Application site burn 99 6.6% 0 3
Epithelioid mesothelioma 94 6.3% 13 10
Anxiety 68 4.5% 37 4
Injury 66 4.4% 35 5
Erythema 64 4.3% 3 0
Mesothelioma malignant 64 4.3% 20 1
Blister 62 4.1% 4 7
Pleural mesothelioma malignant 62 4.1% 23 7
Burning sensation 58 3.9% 0 2
Application site erythema 56 3.7% 0 2
Peritoneal mesothelioma malignant 50 3.3% 13 8
Skin burning sensation 49 3.3% 0 0
Burns second degree 46 3.1% 0 1

Who Reports MENTHOL Side Effects? Age & Gender Data

Gender: 58.2% female, 41.8% male. Average age: 51.0 years. Most reports from: US. View detailed demographics →

Is MENTHOL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 0
2002 1 0 0
2003 1 0 0
2007 2 1 1
2009 1 1 0
2012 1 0 0
2013 2 0 0
2014 27 0 2
2015 37 1 1
2016 48 2 2
2017 35 1 2
2018 63 3 2
2019 43 2 5
2020 31 1 2
2021 42 5 4
2022 49 17 2
2023 87 21 8
2024 132 27 4
2025 101 7 6

View full timeline →

What Is MENTHOL Used For?

IndicationReports
Product used for unknown indication 717
Myalgia 72
Pain 63
Back pain 59
Analgesic therapy 44
Arthralgia 40
Neck pain 23
Arthritis 16
Muscle strain 15
Pain in extremity 12

MENTHOL vs Alternatives: Which Is Safer?

MENTHOL vs MENTHOL\METHYL SALICYLATE MENTHOL vs MENTHOL\ZINC MENTHOL vs MEPERIDINE MENTHOL vs MEPIVACAINE MENTHOL vs MEPIVACAINE\MEPIVACAINE MENTHOL vs MEPOLIZUMAB MENTHOL vs MEPROBAMATE MENTHOL vs MERCAPTOPURINE MENTHOL vs MEROPENEM MENTHOL vs MEROPENEM ANHYDROUS

Official FDA Label for MENTHOL

Official prescribing information from the FDA-approved drug label.

Drug Description

Ageless Pain Relief when applied topically provides temporary relef from joint pain associated with arthrits. Non-Allergenic Non-Sensinizing Non-Greasy, Stainless No Added Fragrance Quick Absorption Move Freely Ageless Pain Relief is a safe and effective non-narcotic topical pain relieving cream that can add in a wide variety of pain conditions including targeted. long-lastings relief from: - Joint pain - Muscle Pain - Simple Backache - Strains - Bruises exclusively formulated for and distributed by: Isagenix International, LLC 2225 S. Price Rd., Chandier.AZ 85286 3900956762-00 Item #20056

FDA Approved Uses (Indications)

if you are under 18 years of age, ask a doctor before use. before using this product, read the enclosed self help guidefor complete directions and other information begin using the patch on your quit day if you smoke more than 10cigarettes per day, use the following schedule below: lf you smoke 10 or less cigarettes per day, do not use Step 1(21 mg). Start with Step 2(14 mg) for 6 weeks, then Step3(7 mg) for 2 weeks and then stop. apply one new patch every 24 hours on skin that is dry, clean and hairless. removebacking from patch and immediately press onto skin. Hold for 10 seconds. wash hands after applying or removing patchSave pouch to use for patch disposal Dispose of the used patches by folding sticky ends together and putting in pouch. the used patch should be removed and a new one applied to a different skin site at the same time each day. if you havevivid dreams, you may remove the patch at bedtime and apply a new one in the morning. you may wear the patch for 18to 24 hours do not wear more than one patch at a time do not cut patch in half or into smaller pieces do not leavepatch on for more than 24 hours because if may irritate your skin and loses strength after 24 hours to avoid possibleburns, remove patch before underaoing and MRllmaanetic resonance imaging) procedures it is important to complete treatment. lf you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider. steps

Dosage & Administration

Directions ■ adults and children 12 years of age and older: ■ remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle ■ carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area ■ once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area ■ apply to the affected area not more than 3 to 4 times daily ■ wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. ■ children under 12 years of age: ask a doctor

Directions ■ adults and children 12 years of age and older: ■ remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle ■ carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area ■ once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area ■ apply to affected area not more than 3 to 4 times daily ■ wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. ■ children under 12 years of age: ask a doctor

Directions ■ adults and children 12 years of age and older: ■ remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle ■ carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area ■ once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area ■ apply to the affected area not more than 3 to 4 times daily ■ wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. ■ children under 12 years of age: ask a doctor

Directions adults and children 12 years of age and older: ■ remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle ■ carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area ■ once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area ■ apply to affected area not more than 3 to 4 times daily ■ wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. children under 12 years of age: ask a doctor

Known Adverse Reactions

Adverse Reactions Section DISTRIBUTED BY TOPCO ASSOCIATES LLC ITASCA, IL 60143 ©TOPCO VIJA 0524 QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com Scan here for more information or call 1-888-423-0139 QUALITY GUARANTEED

Warnings

Warnings For external use only Do not use on wounds or on irritated or damaged skin with a heating pad When using this product use only as directed do not bandage tightly avoid contact with eyes and mucous membranes do not expose the area to local heat or to direct sunlight rare cases of serious burns have been reported with products of this type a transient burning sensation may occur upon application but generally disappears in several days avoid applying into skin folds Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days redness is present or excessive skin irritation occurs you experience severe burning pain, swelling, or blistering where the product was applied If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only Do not use ■ on wounds or on irritated or damaged skin ■ with a heating pad When using this product ■ use only as directed ■ do not bandage tightly ■ avoid contact with eyes and mucous membranes ■ do not expose the area to local heat or to direct sunlight ■ rare cases of serious burns have been reported with products of this type ■ a transient burning sensation may occur upon application but generally disappears in several days ■ avoid applying into skin folds Stop use and ask a doctor if ■ condition worsens or symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days ■ redness is present or excessive skin irritation occurs ■ you experience severe burning pain, swelling, or blistering where the product was applied If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only Do not use ■ on wounds or on irritated or damaged skin ■ with a heating pad When using this product use only as directed do not bandage tightly avoid contact with eyes and mucous membranes do not expose the area to local heat or to direct sunlight rare cases of serious burns have been reported with products of this type a transient burning sensation may occur upon application but generally disappears in several days avoid applying into skin folds Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days redness is present or excessive skin irritation occurs you experience severe burning pain, swelling, or blistering where the product was applied If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only Do not use ■ on wounds or on irritated or damaged skin ■ with a heating pad When using this product ■ use only as directed ■ do not bandage tightly ■ avoid contact with eyes and mucous membranes ■ do not expose the area to local heat or to direct sunlight ■ rare cases of serious burns have been reported with products of this type ■ a transient burning sensation may occur upon application but generally disappears in several days ■ avoid applying into skin folds Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days redness is present or excessive skin irritation occurs you experience severe burning pain, swelling, or blistering where the product was applied If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Precautions

SHARE BEFORE USE: IT IS NORMAL FOR THIS PRODUCT TO GIVE THE IMPRESSION OF A LIQUID SOUND UON SHAKING. DO NOT ALLOW THERA-GESIC ® TO COMEIN CONTACT WITH ANY SURFACE, OTHER THAN SKIN. Do not use this product if tube is punctured. Lot number and expiration date on end of carton. MISSION PHARMACAL COMPANY, San Antonio, TX 78230 1355 50588 03 Rev 001090

Active Ingredient

Drug Facts Active Ingredients Purpose Menthol 1%...............................................................................................................................................................................................................................................................................................................................................................................

Analgesic Methyl Salicylate

15%......................................................................................................................................................................................................................................................................................................................................................... Counterirritant

Inactive Ingredients

Fortify inactive ingredients: cinnamon oil, eucalyptus oil, melaleuca alternifolia (tea tree) leaf oil, pelargonium graveolens oil, peppermint oil, pine needle oil, rosmarinus officinalis (rosemary) leaf oil, and vitis vinifera (grape) seed oil.

Pain

Release anthemis nobilis flower oil, eucalyptus oil, lavender oil, melaleuca leucadendron cajaput oil, origanum majorana leaf oil, peppermint oil, rosmarinus officinalis (rosemary) leaf oil, and vitis vinifera (grape) seed oil.

Peppermint Halo

Ingredients: mentha piperita (peppermint) oil, eucalyptus globulus leaf oil, melaleuca leucadendron cajaput oil, rosmarinus officinalis (rosemary) leaf oil, lavandula angustifolia (lavender) oil, and vetiveria zizanoides root oil.

Gutzy

Ingredients : vitis vinifera (grape) seed oil, foeniculum vulgare (fennel) oil, mentha piperita (peppermint) oil, anthemis nobilis flower oil, piper nigrum (pepper) seed oil, and commiphora myrrha oil.

Stress Release

Ingredients: vitis vinifera (grape) seed oil, lavandula angustifolia (lavender) oil, citrus aurantium dulcis (orange) peel oil, anthemis nobilis flower oil, vetiveria zizanoides root oil, pelargonium graveolens oil, salvia sclarea (clary) oil, and myrtus communis oil.

Brainstorm

Ingredients: simmondsia chinensis (jojoba) seed oil, myrtus communis oil, citrus limon (lemon) peel oil, citrus aurantium dulcis (orange) peel oil, pelargonium graveolens oil, cedrus atlantica wood oil, salvia sclarea (clary) oil, eugenia caryophyllus (clove) flower oil.

Energy

Ingredients : vitis vinifera (grape) seed oil, citrus limon (lemon) peel oil, rosmarinus officinalis (rosemary) leaf oil, mentha piperita (peppermint) oil, citrus aurantium bergamia (bergamot) fruit oil and ocimum basilicum (basil) oil.

Sleep

Well ingredients : lavandula angustifolia (lavender) oil, citrus aurantium dulcis (orange) peel oil, citrus reticulata (tangerine) peel oil, anthemis nobilis flower oil, chamomilla recutita (matricaria) flower oil, vetiveria zizanioides root oil, origanum majorana leaf oil, valeriana officinalis root oil, jasminum officinale (jasmine) oil and citrus aurantium amara (bitter orange) flower oil.