Menthol, unspecified form/Methyl salicylate

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with various conditions, including:

• Arthritis

• Simple backache

• Strains

• Sprains

• Bruises

• Cramps

The drug may also assist in the warm-up process when combined with stretching and calisthenics, particularly in cool, damp weather. It is recommended to apply generously to the affected area and massage until thoroughly absorbed into the skin. For longer-lasting relief, covering the area with cloth and securing it with an elastic wrap may be beneficial.

Limitations of Use:

• For children 12 years or younger, consultation with a doctor is advised before use.

• Avoid contact with eyes, mouth, or mucous membranes, and do not bandage tightly or apply to wounds or damaged skin.

This drug is not indicated for any teratogenic or nonteratogenic effects, as none have been mentioned in the provided information.

Dosage and Administration

Adults and children 12 years of age and older are advised to apply the product generously to the affected area, massaging until thoroughly absorbed into the skin. This application may be repeated as necessary, but should not exceed 3 to 4 times daily. For children under 12 years of age, consultation with a physician is recommended prior to use.

For products specifically indicated for children aged 2 years and older, the same dosage applies: apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age should not use these products without consulting a doctor.

When using patches, adults and children over 12 years may apply one patch to the affected area, leaving it in place for up to 8 to 12 hours. A maximum of 2 patches may be used per day, and they should not be applied for more than 3 consecutive days. Children under 12 years should not use patches without medical advice.

It is important to wash hands thoroughly with soap and water after applying the product, unless treating the hands themselves. If excessive irritation occurs, or if symptoms persist for more than 7 days, the use of the product should be discontinued and a physician consulted.

Contraindications

Use of this product is contraindicated in the following situations:

• Do not apply to wounds, damaged, broken, or irritated skin.

• Do not bandage tightly.

• Do not use with a heating pad or other heat sources.

• Avoid contact with eyes and mucous membranes.

• Do not use if allergic to salicylates, aspirin, or any ingredients in the product.

• Do not use on children under 12 years of age with arthritis-like conditions.

• Do not use if excessive irritation of the skin develops.

• Do not use if seal is missing or broken.

• Do not use otherwise than as directed.

• If swallowed, seek medical help or contact a Poison Control Center immediately.

• Do not use if pregnant or breastfeeding unless directed by a healthcare professional.

• Do not use if skin is sensitive to oil of wintergreen (methyl salicylate).

• Do not use if allergic to topical products or if the stomach bleeding warning applies.

• Do not use if sweating (such as from exercise or heat).

• Do not use any patch from a pouch that has been open for 14 or more days.

• Do not use right before or after heart surgery.

• Do not use on the face or rashes.

• Do not use in or near eyes; if product gets into eyes, rinse thoroughly with water.

• Do not use on reddened, damaged, or sensitive skin.

• Do not use on children under 5 years of age.

Warnings and Precautions

For external use only.

General Precautions:

• Use only as directed.

• Avoid contact with eyes and mucous membranes.

• Do not apply to wounds or damaged skin.

• Do not bandage tightly or use with a heating pad.

• If pregnant or breastfeeding, consult a healthcare professional before use.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Stop Taking and Call Your Doctor If:

• Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

• Redness or excessive irritation develops.

• You experience signs of injury, such as pain, swelling, or blistering where the product was applied.

• You have a history of allergic reactions to aspirin or salicylates.

Get Emergency Medical Help If:

• Swallowed, get medical help or contact a Poison Control Center right away.

• Severe skin irritation occurs or if you experience nausea, vomiting, abdominal discomfort, diarrhea, or skin rash.

Special Considerations:

• Do not use on children under 12 years of age with arthritis-like conditions.

• If you have redness over the affected area, consult a doctor before use.

• Discontinue use if excessive skin irritation occurs.

Flammability Warning:

• Some products may be flammable; keep away from fire or flame, and do not use while smoking or near heat sources.

Note:

• A transient burning sensation may occur upon application but generally disappears within a few days. If severe burning occurs, discontinue use immediately.

Side Effects

Patients using topical analgesics should be aware of the following adverse reactions and warnings associated with these products:

General Warnings

• For external use only.

• Avoid contact with eyes and mucous membranes.

• Do not apply to wounds or damaged skin.

• Do not bandage tightly or use with heating pads.

• If swallowed, seek medical help or contact a Poison Control Center immediately.

Common Adverse Reactions

• Skin Irritation: Patients may experience excessive skin irritation, redness, or a burning sensation upon application. If these symptoms occur, discontinue use and consult a doctor.

• Condition Worsening: If the condition worsens or symptoms persist for more than 7 days, patients should stop using the product and seek medical advice.

• Transient Burning Sensation: A temporary burning sensation may occur upon application but generally resolves within a few days.

Serious Adverse Reactions

• Allergic Reactions: Patients with a history of allergic reactions to aspirin or salicylates should consult a physician before use.

• Stomach Bleeding Warning: Some products contain NSAIDs, which may increase the risk of stomach bleeding, particularly in patients over 60, those with a history of ulcers, or those taking blood thinners.

• Signs of Injury: If patients experience signs of injury such as pain, swelling, or blistering at the application site, they should stop use and consult a doctor.

Specific Conditions for Discontinuation

Patients should stop using the product and consult a doctor if:

• Symptoms clear up and then recur within a few days.

• Redness or irritation develops.

• Symptoms persist for more than 7 days.

• Severe skin irritation occurs.

• Pain persists for more than 10 days (specific to certain products).

Special Populations

• Pregnant or Breastfeeding: Consult a healthcare professional before use if pregnant or breastfeeding.

• Children: Do not use on children under 12 years of age with arthritis-like conditions without consulting a doctor.

Additional Notes

• Keep out of reach of children to prevent accidental ingestion.

• If any adverse reactions occur, including nausea, vomiting, abdominal discomfort, or diarrhea, patients should seek medical attention.

Patients are encouraged to read the product labels carefully and follow the instructions provided to minimize the risk of adverse reactions.

Drug Interactions

The reviewed products exhibit a range of interactions, primarily focusing on allergy considerations and the absence of significant drug interactions.

Allergy Considerations

• Pain Relieving Balm: Individuals with a known allergy to aspirin or salicylates are advised to consult a healthcare professional prior to use.

Absence of Interactions

For the majority of the products reviewed, including but not limited to Cramergesic, Heating Pain Relief, Eagle Brand, and various creams and ointments, no specific drug interactions or drug and laboratory test interactions were identified. This includes products such as:

• Muscle Rub

• Theracare Muscle and Joint Pain Relieving Cream

• Doloflex Pain Relief

• Tiger Balm

• Salonpas Pain Relieving Jet

Overall, while one product highlights a potential allergy concern, the remaining products do not present any documented drug interactions or laboratory test interactions. Users should still exercise caution and consult healthcare providers for personalized advice, especially if they have pre-existing conditions or are taking other medications.

Pediatric Use

Pediatric patients should be carefully monitored when using topical pain relief products.

Efficacy and Safety

• Children under 2 years of age: Generally advised to consult a doctor before use. Products should not be used without medical guidance.

• Children aged 2 to 11 years: Many products require consultation with a physician prior to use, especially for those with arthritis-like conditions or other specific health concerns.

• Children aged 12 years and older: Most products can be used, but it is recommended to apply to the affected area not more than 3 to 4 times daily.

Dosage Guidelines

• Ointments and Creams: For children 2 years and older, apply to the affected area not more than 3 to 4 times daily. Specific products may have additional instructions regarding application techniques (e.g., massage into the skin).

• Consultation Required: For children under 12 years, consultation with a healthcare provider is often necessary before use, particularly for those with underlying health conditions or if the child is prone to allergic reactions.

Cautions

• Accidental Ingestion: All products should be kept out of reach of children to prevent accidental ingestion. In case of ingestion, immediate medical help should be sought.

• Specific Conditions: Products should not be used on children under 12 years of age with arthritis-like conditions without prior medical advice.

Healthcare providers should ensure that caregivers are aware of these guidelines to promote safe and effective use of topical pain relief products in pediatric patients.

Geriatric Use

No specific information regarding geriatric use, dosage adjustments, safety concerns, or special precautions for elderly patients is provided in the inserts for the majority of the products reviewed, including various ointments, creams, gels, and patches.

However, it is important to note that for the Major Arthritis Pain Relief Patch, there is an increased risk of stomach bleeding in patients aged 60 years or older. Therefore, healthcare professionals should exercise caution and consider this risk when prescribing this product to geriatric patients.

Given the lack of specific data on geriatric use across most products, healthcare providers are advised to monitor elderly patients closely for any adverse effects and to consider individual patient factors when determining treatment plans.

Pregnancy

Pregnant patients should exercise caution when using topical analgesics, as the safety of many products during pregnancy has not been established. It is recommended that pregnant patients consult a healthcare professional before using any pain relief products, including lotions, creams, gels, and patches.

Several products specifically advise consulting a healthcare provider prior to use if pregnant or breastfeeding, including but not limited to Mentholatum Pain Relieving Lotion, Pain Relieving Balm, and various formulations of Eagle Brand products. The use of methyl salicylate, particularly after 20 weeks of pregnancy, is discouraged unless directed by a physician, as it may pose risks to the fetus or complications during delivery.

Certain products, such as Theracare Muscle and Joint Pain Relieving Cream and Doloflex Pain Relief Gel, indicate that potential risks to the fetus are not clearly defined, and caution is advised. Additionally, some products, like Muscle Rub and Careall Muscle Rub, have not been evaluated for safety during pregnancy, and no specific contraindications or dosage modifications are provided.

In summary, while many topical analgesics do not have explicit contraindications for use during pregnancy, the lack of established safety data necessitates a cautious approach. Pregnant patients should always seek medical advice before using these products to ensure the safety of both themselves and their developing fetus.

Lactation

Lactating mothers are advised to consult a healthcare professional before using various pain relief products, as many of these formulations may have implications for breastfeeding. There is a potential for excretion of certain ingredients in breast milk, and caution is recommended when using these products while nursing.

For instance, Cramergesic ointment has been noted to potentially excrete in breast milk, and its safety during lactation has not been established. Monitoring for any adverse reactions in breastfed infants is advised. Similarly, the use of Asystem Radical Relief Gel Roll-on may lead to excretion in breast milk, with insufficient data on its effects on nursing infants, warranting caution.

Other products, such as Doloflex Pain Relief and various creams and ointments, do not provide specific warnings or recommendations for nursing mothers, indicating a lack of data on their safety during lactation. However, it remains prudent for lactating mothers to seek guidance from healthcare professionals before use.

Overall, while some products lack specific lactation-related warnings, the general recommendation is to consult a healthcare provider to ensure the safety of both the mother and the breastfed infant.

Renal Impairment

Patients with renal impairment may require careful consideration when using certain medications. While many products lack specific guidance regarding dosage adjustments or monitoring for individuals with kidney issues, there are notable exceptions.

For instance, Shuang Long Pain Relieving Oil indicates that renal impairment may necessitate a reduced dose, and it is recommended that patients have their creatinine clearance monitored regularly. Additionally, renal function tests should be performed to assess kidney health, particularly for those with significant renal impairment to avoid potential toxicity.

Similarly, Medicated Oil also advises that dosage adjustments may be necessary for patients with renal impairment. Regular monitoring of creatinine clearance and renal function tests is recommended to ensure patient safety.

In contrast, the majority of other products reviewed do not provide specific information regarding renal impairment, dosage adjustments, or monitoring requirements. Therefore, healthcare providers should exercise caution and consider individual patient circumstances when prescribing these medications to patients with reduced kidney function. It is advisable for patients to consult their healthcare provider for personalized recommendations and monitoring strategies.

Hepatic Impairment

Patients with hepatic impairment have no specific dosage adjustments, special monitoring, or precautions outlined for the use of the following products: Mentholatum Pain Relieving Lotion, Cramergesic Ointment, Pain Relieving Balm Liquid, Heating Pain Relief Cream, Eagle Brand Liquid and Ointment, Hemp Pain Lotion, Sound Body Extra Strength Cold and Hot Cream, Shuang Long Pain Relieving Oil, Cold and Heat Pain Relieving Cream, Asperflex Cream, and various other topical analgesics.

The absence of information regarding hepatic impairment suggests that these products may not require modifications in dosing or monitoring for patients with liver issues. However, healthcare providers should exercise caution and consider individual patient factors when prescribing these products to patients with hepatic impairment, as the lack of specific guidance does not eliminate the potential for adverse effects or altered pharmacokinetics in this population.

Overdosage

In the event of an overdose or accidental ingestion of any of the products listed, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Symptoms of overdose may vary, but common recommendations include monitoring for signs of distress or adverse reactions.

For products that are ingested, the following actions are advised:

• Contact a Poison Control Center: Immediate communication with a Poison Control Center is crucial. The national hotline (1-800-222-1222) can provide guidance on the necessary steps to take.

• Seek Professional Medical Help: If ingestion occurs, obtaining medical help promptly is essential to ensure proper evaluation and treatment.

• Keep Out of Reach of Children: To prevent accidental poisoning, all products should be stored safely away from children.

Specific products that require immediate action if swallowed include, but are not limited to:

• Cramergesic

• Eagle Brand (various forms)

• Pain Relieving Creams and Gels

• Various topical analgesics

In summary, vigilance is necessary when using these products, and any signs of overdose should be treated as a medical emergency.

Nonclinical Toxicology

Teratogenic Effects

Several products indicate a need for caution during pregnancy and breastfeeding. Specifically, it is advised to consult a health professional before use of certain formulations if pregnant or breastfeeding, as seen in the Heating Pain Relief, Timing Pain Savior Fragrant Ginger Patch, Healthwise Pain Relief Patch, and Salonpas Pain Relieving Jet. Additionally, the Major Arthritis Pain Relief Patch explicitly states that it should not be used during the last three months of pregnancy due to potential risks to the unborn child or complications during delivery.

Non-Teratogenic Effects

Non-teratogenic effects reported across various products include transient sensations such as burning upon application, which may occur but typically resolve within a week. This is noted in the Meijer Extra Strength Cold and Hot Therapy product. Other products did not provide specific information regarding non-teratogenic effects.

Nonclinical Toxicology Section

The nonclinical toxicology sections of the reviewed products generally lack specific information. Most labels do not provide relevant data regarding animal pharmacology and toxicology, indicating a gap in available nonclinical study data.

Animal Pharmacology and Toxicology

No relevant information regarding animal pharmacology and toxicology was extracted from the reviewed labels. The absence of such data limits the understanding of the potential effects and safety profiles of these products in nonclinical settings.

Storage and Handling

Cramergesic is supplied as an ointment and should be stored at room temperature, kept out of reach of children. Pain Relieving Balm is available in liquid form and must also be stored at room temperature, protected from light, and kept tightly closed; it should be discarded after opening. Heating Pain Relief is provided as a cream and should be stored tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

Eagle Brand is offered in liquid and ointment forms, both requiring storage below 86°F (30°C). Shuang Long Pain Relieving Oil should be kept tightly closed and stored in a cool, dry place, with the product not to be used if the seal is broken. Asperflex cream should be stored at 20°-25°C (68°-77°F) with the cap closed tightly after use. Astonea Care Muscle and Joint Pain Relief Cream also requires storage at 20° to 25°C (68° to 77°F) and should not be used if the tube seal under the cap is broken.

Pain Reliever Cream should be stored at controlled room temperature of 20º-25ºC (68º-77ºF). Muscle Rub cream must not be used if the seal on the tube is damaged or not visible, and it should be stored at room temperature. Theracare Muscle and Joint Pain Relieving Cream requires storage at 20° to 25°C (68° to 77°F) and should not be used if the tube seal under the cap is broken.

Eagle Brand oil products should be stored below 86°F (30°C). My Hemp Md CBD Muscle and Deep Tissue Cream is for external use only and should not be used if the quality seal is broken or missing. Amrutanjan Relief Strong Pain Balm should be stored at room temperature, and the carton seal should not be broken or tampered with.

Dgh Greaseless Muscle Rub should be stored at 15 to 30°C (59 to 86°F) with the cap tightly closed after use. The same temperature range applies to Proplex Greaseless Muscle Rub. Tiger Balm products, including liniment and gel forms, should be stored at room temperature.

For patches like Salonpas Arthritis Pain, they should be stored at 20 - 25 degrees Celsius (68-77 degrees Fahrenheit), away from direct sunlight and excessive moisture. Other products, such as the Timing Pain Savior Cool Herbal Patch, should be kept tightly closed after opening and stored below 20℃ (68 ℉) in a dry place away from direct sunlight.

In summary, most products should be stored at room temperature or within specified temperature ranges, kept tightly closed, and protected from light and moisture. Discard any unused portions after opening, and ensure that seals are intact before use.