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Menthol/Methyl salicylate

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This product has been discontinued

Active ingredients
  • Menthol 1.74 g/29 g
  • Methyl Salicylate 4.06 g/29 g
Other brand names
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2012
Label revision date
September 19, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 1.74 g/29 g
  • Methyl Salicylate 4.06 g/29 g
Other brand names
Dosage form
Ointment
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 2012
Label revision date
September 19, 2017
Manufacturer
Geritrex LLC
Registration number
part348
NDC root
54162-555
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

You may be looking for information about a medication that is used for treating certain conditions in adults and children aged 2 years and older. This medication is applied directly to the affected area of the skin, typically no more than 3 to 4 times a day. If you have a child under 2 years of age, it's important to consult a doctor before use.

While specific details about the drug's name and mechanism of action are not provided, it is designed to help alleviate symptoms related to skin conditions. Always follow the guidance of a healthcare professional for the best results.

Uses

If you or your child is 2 years of age or older, you can apply this medication generously to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it's important to consult a doctor before use.

There are no specific concerns regarding teratogenic effects (which refer to substances that can cause birth defects) or nonteratogenic effects (which do not cause birth defects) associated with this medication. Always ensure you follow the recommended guidelines for safe and effective use.

Dosage and Administration

To use this medication effectively, apply it generously to the affected area. You should do this no more than 3 to 4 times each day. It's important to follow this guideline to ensure the best results while minimizing any potential side effects.

If you are considering this medication for a child under 2 years of age, please consult a doctor first. This step is crucial to ensure the safety and appropriateness of the treatment for young children.

What to Avoid

If you are considering this medication for a child under 2 years of age, it is crucial to consult a doctor first. This is important to ensure the safety and appropriateness of the treatment for young children.

Additionally, be aware that this medication may have potential for abuse or misuse, and it is classified as a controlled substance. This means it should be used only as directed by a healthcare professional to avoid issues related to dependence (a condition where the body becomes reliant on a substance). Always follow your doctor's instructions carefully.

Side Effects

You should be aware of some important warnings when using this product. Avoid contact with your eyes or any mucous membranes, as this can cause irritation. If you experience excessive skin irritation, stop using the product right away. It's also important not to bandage the area tightly or apply it to wounds or damaged skin, especially if you're using a heating pad.

If your condition worsens, or if symptoms last more than seven days or come back shortly after improving, discontinue use and consult a doctor. In case of accidental swallowing, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

It's important to use this product safely to avoid any potential issues. Make sure to keep it away from your eyes and any mucous membranes. If you notice excessive irritation on your skin, stop using it right away. Avoid tightly bandaging the area where you apply the product, and do not use it on wounds, damaged skin, or in combination with a heating pad.

If your condition worsens, or if your symptoms last more than 7 days, or if they improve and then come back within a few days, stop using the product and consult your doctor. In case of accidental swallowing, seek medical help or contact a Poison Control Center immediately. Your safety is the top priority, so please take these precautions seriously.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help right away. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help immediately. Remember, it’s always better to be safe and get checked out if you suspect an overdose.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available about its safety or potential risks to you or your developing baby. The insert does not indicate whether the product should be avoided during pregnancy, nor does it provide any dosage changes or special precautions for pregnant individuals.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any medication or product to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your nursing infant. Additionally, the safety of this product during lactation has not been established, so discussing your options with a healthcare professional is crucial to ensure the well-being of both you and your baby.

Pediatric Use

When using this medication for children aged 2 years and older, you should apply it generously to the affected area, but no more than 3 to 4 times a day. For children under 2 years of age, it’s important to consult a doctor before use to ensure safety and proper care. Always follow these guidelines to help keep your child safe and healthy.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it's important to approach any new treatment with caution. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach for your individual health needs, especially if there are existing health conditions or medications involved. Always prioritize safety and open communication with your medical team.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and appropriate for your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20º-25º C (68º-77º F). This temperature range helps maintain its effectiveness. After each use, make sure to close the cap tightly to prevent contamination and preserve the product's integrity.

Handling your product safely is crucial. Always ensure that you are in a clean environment to avoid introducing any unwanted substances. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it generously up to 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, consult a doctor before use.

Be careful to avoid contact with your eyes or mucous membranes, and stop using the product if you experience excessive skin irritation. Do not wrap the area tightly, apply it to wounds or damaged skin, or use it with a heating pad. If your condition worsens, symptoms persist for more than 7 days, or if they clear up and then return within a few days, discontinue use and consult a doctor. If the product is swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

How should I apply this product?

For adults and children 2 years of age and older, apply generously to the affected area not more than 3 to 4 times daily. For children under 2 years of age, consult a doctor.

What should I do if I experience excessive skin irritation?

You should discontinue use if excessive irritation of the skin develops.

Can I use this product on wounds or damaged skin?

No, do not apply this product to wounds, damaged skin, or use it with a heating pad.

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

If your condition worsens or symptoms persist for more than 7 days, or if they clear up and reoccur within a few days, discontinue use and consult a doctor.

Is this product safe to use during pregnancy?

There is no specific information regarding the use of this product during pregnancy, and no contraindications or associated risks to the fetus are mentioned.

Can nursing mothers use this product?

Nursing mothers should consult a doctor before using this product, as there is a potential for excretion in breast milk.

What should I do if I accidentally swallow this product?

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

What precautions should I take when using this product?

Avoid contact with eyes or mucous membranes, and do not bandage tightly. If irritation occurs, discontinue use.

How should I store this product?

Store at room temperature between 20º-25º C (68º-77º F) and close the cap tightly after use.

Packaging Info

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

Packaging configurations for Analgesic Balm.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the topical treatment of affected areas in adults and children aged 2 years and older. It should be applied generously to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a healthcare professional is recommended prior to use.

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

Dosage and Administration

Healthcare professionals are advised to apply the medication generously to the affected area, ensuring that it is not applied more than 3 to 4 times daily. For pediatric patients under 2 years of age, it is essential to consult a physician prior to administration to ensure safety and appropriateness of treatment.

Contraindications

Use is contraindicated in children under 2 years of age. Consultation with a healthcare professional is advised prior to administration in this age group.

Warnings and Precautions

Contact with eyes or mucous membranes should be strictly avoided. In the event of excessive skin irritation, the use of the product must be discontinued immediately.

It is imperative that the product is not applied inappropriately; do not bandage tightly, apply it to wounds or damaged skin, or use it in conjunction with a heating pad.

Should the condition worsen, or if symptoms persist for more than 7 days, or if symptoms resolve and then reoccur within a few days, the use of this product should be discontinued, and a healthcare professional should be consulted for further evaluation and guidance.

In cases of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Side Effects

Patients should be advised to avoid contact with eyes or mucous membranes when using this product. In the event of excessive skin irritation, discontinuation of use is recommended. It is important not to bandage tightly, and the product should not be applied to wounds or damaged skin, nor should it be used in conjunction with a heating pad.

Should the condition worsen, or if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days, patients are advised to discontinue use and consult a healthcare professional. In cases of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Analgesic Balm.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication generously to the affected area up to 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

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 should be aware that no specific information regarding the use of this product during pregnancy is provided in the prescribing information. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding the use of this product during pregnancy are mentioned. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the safety of this product during lactation has not been established. Therefore, healthcare professionals should exercise caution when recommending this product to nursing mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical assistance. If the substance is ingested, healthcare professionals should be contacted without delay, or the individual should reach out to a Poison Control Center for guidance.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Healthcare providers are advised to assess the situation thoroughly and initiate appropriate management protocols based on the specific circumstances and symptoms presented.

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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that children under 2 years of age require consultation with a doctor before using this medication. It is important for caregivers to understand the necessity of professional guidance in this age group to ensure safety and appropriate treatment.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature, within the range of 20º to 25º C (68º to 77º F).

To ensure the integrity of the product, it is important to close the cap tightly after each use. Proper handling and storage conditions are crucial for maintaining the product's efficacy and safety.

Additional Clinical Information

The product is administered topically, with a recommended application of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to avoid contact with eyes and mucous membranes, and to discontinue use if excessive skin irritation occurs. It is important not to tightly bandage the area, apply the product to wounds or damaged skin, or use it in conjunction with a heating pad. Patients are advised to seek medical attention if the condition worsens, if symptoms persist beyond 7 days, or if symptoms clear and then reoccur shortly thereafter. In the event of ingestion, immediate medical help or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Analgesic Balm, 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 Analgesic Balm, 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

Last AI update:

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.