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Menthol/Methyl salicylate

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This product has been discontinued

Active ingredients
  • Menthol 10 g/100 g
  • Methyl Salicylate 30 g/100 g
Other brand names
Dosage form
Stick
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1991
Label revision date
March 1, 2012
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 10 g/100 g
  • Methyl Salicylate 30 g/100 g
Other brand names
Dosage form
Stick
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1991
Label revision date
March 1, 2012
Manufacturer
H. J. Harkins Company, Inc.
Registration number
part348
NDC root
52959-028
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

This medication is designed to temporarily relieve minor pain associated with various conditions, including arthritis, simple backache, muscle strains, sprains, bruises, and cramps. It works by targeting the discomfort you may experience from these common ailments, helping you feel more comfortable and active.

Uses

If you're dealing with minor pain, this medication can help provide temporary relief. It's effective for various types of discomfort, including pain from arthritis, simple backaches, muscle strains, sprains, bruises, and cramps. Whether you're recovering from an injury or just experiencing everyday aches, this medication can support your comfort.

Rest assured, there are no concerns regarding teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects (which refers to other types of harmful effects during pregnancy). You can use this medication with confidence for your minor pain relief needs.

Dosage and Administration

When using this medication, if you are an adult or a child over 12 years old, you should apply a generous amount to the area that is causing you pain. Make sure to massage it into your skin until it is fully absorbed. You can repeat this process as needed, but do not apply it more than four times in a single day.

If you are caring for a child who is 12 years old or younger, it’s important to consult a doctor before using this medication. They can provide guidance on the appropriate use for younger patients.

What to Avoid

It's important to use this medication safely to avoid any potential issues. You should not bandage the area tightly or use a heating pad while using this product. Additionally, avoid applying it to wounds or any damaged, broken, or irritated skin, as this can lead to complications.

By following these guidelines, you can help ensure that you use the medication effectively and safely. If you have any questions or concerns about its use, please consult your healthcare provider for more information.

Side Effects

If you have a history of allergic reactions to aspirin or salicylates, it's important to talk to your doctor before using this medication.

You should stop using the product and consult your doctor if your condition worsens, if you notice any redness or irritation, or if your symptoms last longer than 7 days or return after clearing up.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. If you have a history of allergic reactions to aspirin or salicylates, consult your doctor before using it. Always follow the directions provided and do not apply it tightly or use it with a heating pad. Be careful to keep it away from your eyes and mucous membranes, and do not apply it to wounds or any broken or irritated skin.

If your condition worsens, if you notice redness or irritation, or if your symptoms last longer than 7 days or return after clearing up, stop using the product and contact your doctor. If the product is swallowed, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center. They can provide guidance on what to do next.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking professional advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your healthcare provider regarding your breastfeeding journey.

Pediatric Use

If you are considering this medication for a child who is 12 years old or younger, it’s important to consult with a doctor first. This ensures that the treatment is safe and appropriate for your child's specific needs. Always prioritize professional guidance when it comes to the health of your little ones.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions and share all the medications and supplements you are using. This helps your provider monitor your health effectively and make informed decisions about your treatment.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, away from excessive heat. It's important to keep the container tightly closed when not in use to prevent contamination. Once opened, please remember to discard the product to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, gently massaging it into the skin until fully absorbed. For adults and children over 12 years, you can repeat this process as needed, but do not exceed four applications in one day. If the user is a child under 12 years old, consult a doctor before use.

It's important to be aware of a few safety precautions. If you have a history of allergic reactions to aspirin or salicylates, talk to your doctor before using this product. Additionally, if you are pregnant or breastfeeding, consult a healthcare professional. Always keep the medication out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What minor pains does this drug relieve?

This drug temporarily relieves minor pain associated with arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

How should adults and children over 12 use this drug?

Apply generously to the affected area and massage until thoroughly absorbed into the skin. You can repeat this process as necessary, but not more than 4 times daily.

What should children 12 years or younger do before using this drug?

Children 12 years or younger should ask a doctor before use.

Are there any specific instructions for using this drug?

Use only as directed, avoid bandaging tightly or using with a heating pad, and do not apply to wounds or damaged skin.

What should I do if I experience an allergic reaction?

If you are prone to allergic reactions from aspirin or salicylates, consult a doctor before use.

What should I do if my condition worsens or symptoms persist?

Stop use and ask a doctor if your condition worsens, redness is present, irritation develops, or symptoms persist for more than 7 days.

What precautions should I take if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health care professional before use.

What should I do if the drug is swallowed?

If swallowed, get medical help or contact a Poison Control Center right away.

How should I store this drug?

Store at room temperature, protect from excessive heat, and keep the container tightly closed. Discard after opening.

Packaging Info

Below are the non-prescription pack sizes of Menthol and Methyl Salicylate. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Menthol and Methyl Salicylate.
Details

Drug Information (PDF)

This file contains official product information for Menthol and Methyl Salicylate, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The drug associated with SPL code 34089-3 does not have specific details available regarding its chemical name, physical characteristics, or inactive ingredients. Further information may be required to provide a comprehensive description of the drug's properties and formulation.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children over 12 years of age, the recommended dosage is to apply the product generously to the affected area. The application should be followed by a gentle massage into the painful area until the product is thoroughly absorbed into the skin. This process may be repeated as necessary, but should not exceed four applications within a 24-hour period.

For children 12 years of age or younger, it is advised to consult a physician before use.

Contraindications

The product should not be used in the following situations:

Application of the product is contraindicated on wounds or damaged, broken, or irritated skin due to the potential for exacerbating the condition. Additionally, it is advised not to bandage tightly or use in conjunction with a heating pad, as this may lead to adverse effects.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to refer to the inside label for complete drug facts.

Allergy Alert: Patients with a known allergy to aspirin or salicylates should consult a healthcare provider prior to use to prevent potential allergic reactions.

General Precautions: It is imperative that the product is used only as directed. Patients should be cautioned against bandaging the area tightly or using the product in conjunction with a heating pad, as this may exacerbate adverse effects. Care should be taken to avoid contact with the eyes or mucous membranes, and the product should not be applied to wounds or any damaged, broken, or irritated skin.

Stop Use and Consult a Doctor If: Patients should discontinue use and seek medical advice if their condition worsens, if redness occurs, if irritation develops, or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, medical consultation is advised.

Emergency Medical Help: In the event of accidental ingestion, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately.

Side Effects

Patients should be aware of the potential for adverse reactions associated with the use of this medication. Individuals with a known allergy to aspirin or salicylates are advised to consult a healthcare professional prior to use, as there is a risk of allergic reactions.

In clinical practice, patients are instructed to discontinue use and seek medical advice if any of the following occur: worsening of the condition, the presence of redness, development of irritation, or if symptoms persist for more than seven days. Additionally, if symptoms resolve and then recur within a few days, it is recommended that patients consult a healthcare provider. These precautions are essential to ensure patient safety and effective management of their condition.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Menthol and Methyl Salicylate. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Menthol and Methyl Salicylate.
Details

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed to stop using the product and consult a doctor if any of the following occur: the condition worsens, redness appears, irritation develops, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

When using this product, it is essential for patients to use it only as directed. They should be cautioned against bandaging tightly or using the product in conjunction with a heating pad. Additionally, patients should avoid contact with the eyes and mucous membranes, and they should not apply the product to wounds or to skin that is damaged, broken, or irritated.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is protected from excessive heat. The container must be kept tightly closed to maintain the integrity of the product. Additionally, it is important to discard the product after opening to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with adults and children over 12 years advised to apply it generously to the affected area and massage until fully absorbed, not exceeding four applications per day. For children aged 12 years or younger, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients on specific precautions, including an allergy alert for those with a history of reactions to aspirin or salicylates. Pregnant or breastfeeding patients should also seek advice from a healthcare professional before use. It is important to keep the product out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Menthol and Methyl Salicylate, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Menthol and Methyl Salicylate, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.