MENTHOL: 1,504 Adverse Event Reports & Safety Profile
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Route: ORAL · Manufacturer: McKesson · HUMAN OTC DRUG · FDA Label: Available
First Report: 19320101 · Latest Report: 20250820
What Are the Most Common MENTHOL Side Effects?
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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 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 |
What Is MENTHOL Used For?
| Indication | Reports |
|---|---|
| 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?
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.