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Rocainol Topical Analgesic

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Active ingredients
  • Menthol 8 g/100 g
  • Methyl Salicylate 16 g/100 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 2013
Label revision date
July 10, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 8 g/100 g
  • Methyl Salicylate 16 g/100 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 2013
Label revision date
July 10, 2025
Manufacturer
Compania Internacional de Comercio, S. A. P. I de C. V.
Registration number
M017
NDC root
54312-825
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 can use this medication for the temporary relief of minor aches and pains associated with conditions like arthritis, simple backache, bruises, and sprains. It is designed to help alleviate discomfort, allowing you to feel more comfortable in your daily activities. If you're experiencing any of these types of pain, this medication may be a suitable option for you.

Uses

You can use this medication for the temporary relief of minor aches and pains that may arise from various conditions. This includes discomfort associated with arthritis, simple backaches, bruises, and sprains.

It's important to note that there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects (which refers to other types of harmful effects) related to this medication. Always consult with a healthcare professional if you have any questions or concerns about its use.

Dosage and Administration

You can apply this medication to the affected area up to 3 or 4 times a day. It is suitable for adults and children who are 12 years old and older. If you have a child under 12, it's important to consult a doctor before using this medication to ensure it's safe and appropriate for them. Always follow the recommended frequency to achieve the best results.

What to Avoid

You should avoid using this medication if you are pregnant or if you are giving it to children under 12 years old, unless your doctor specifically instructs you to do so. It's also important not to apply the medication to any wounds or damaged skin, and avoid tightly bandaging the area where it is applied.

If you notice excessive irritation of the skin while using this medication, you should stop using it immediately. Always prioritize your safety and consult with a healthcare professional if you have any concerns.

Side Effects

This product is intended for external use only. You should avoid using it if you are pregnant or if the user is a child under 12 years old, unless a doctor has specifically advised it. It's important not to apply the product to wounds or damaged skin, and you should avoid tightly bandaging the area after application.

If you notice excessive irritation of the skin, stop using the product immediately. Keep it out of reach of children, and if your condition worsens or symptoms persist for more than 7 days, or if they clear up and then return within a few days, please consult a doctor.

Warnings and Precautions

This product is intended for external use only. You should avoid using it if you are pregnant or if the user is a child under 12 years old, unless a doctor has specifically directed you to do so. It's important not to apply the product to any wounds or damaged skin, and you should avoid tightly bandaging the area after application.

If you experience excessive irritation of the skin, stop using the product immediately. Additionally, if your condition worsens, or if symptoms last longer than 7 days or improve only to return within a few days, you should discontinue use and consult your doctor for further advice.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contacting your healthcare provider or local poison control center is crucial. They can provide guidance on what steps to take next. Always remember that when in doubt, it's better to err on the side of caution and seek professional assistance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it is important to avoid using this medication unless your doctor specifically advises you to do so. This precaution also applies to children under 12 years of age. Always consult with your healthcare provider to discuss any potential risks and ensure the safety of both you and your baby.

Lactation Use

If you are breastfeeding, it's important to know that this medication should not be used by pregnant women or children under 12 years of age unless specifically directed by a doctor. Always consult with your healthcare provider before taking any medication while nursing to ensure it is safe for you and your baby. Your health and your child's well-being are the top priorities, so make sure to discuss any concerns you may have about medications and breastfeeding.

Pediatric Use

It's important to be cautious when considering this medication for children. You should not use it in children under 12 years of age unless a doctor specifically advises you to do so. If your child is under 12, it's best to consult with a healthcare professional before administering this medication to ensure their safety and proper care.

Additionally, this medication is not recommended for pregnant women, so if you are pregnant or planning to become pregnant, please discuss this with your doctor as well. Always prioritize your child's health by seeking professional guidance when it comes to medications.

Geriatric Use

While there is no specific information about the use of Rocainol Topical Analgesic in older adults, it’s important to approach any new medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this product. They can provide personalized advice based on your health status and any other medications you may be taking. Always prioritize safety and ensure that any treatment is appropriate for your individual needs.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

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

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medication or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

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

Additional Information

You should apply the medication to the affected area no more than 3 or 4 times a day. This guidance applies to adults and children aged 12 years and older. If the patient is under 12 years old, it's important to consult a doctor before use.

FAQ

What is the primary use of this drug?

This drug provides temporary relief of minor aches and pains associated with arthritis, simple backache, bruises, and sprains.

Who can use this drug?

Adults and children 12 years of age and older can use this drug. Children under 12 years should consult a doctor.

How often can I apply this drug?

You can apply it on the affected area not more than 3 or 4 times daily.

Are there any contraindications for using this drug?

Yes, do not use this drug on pregnant women and children under 12 years of age unless directed by a doctor.

Where should I not apply this drug?

Do not apply it to wounds or damaged skin, and do not bandage tightly.

What should I do if I experience skin irritation?

Discontinue use if excessive irritation of the skin develops.

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

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

How should I store this drug?

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

Packaging Info

Below are the non-prescription pack sizes of Rocainol Topical Analgesic (methyl salicylate, menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Rocainol Topical Analgesic.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including arthritis, simple backache, bruises, and sprains.

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

Dosage and Administration

The medication should be applied to the affected area no more than three to four times daily. This dosing is applicable for adults and children aged 12 years and older. For children under 12 years of age, it is recommended to consult a healthcare professional prior to use.

Contraindications

Use is contraindicated in the following situations:

Pregnant women and children under 12 years of age should not use this product unless directed by a healthcare professional. Application to wounds or damaged skin is also contraindicated due to the potential for adverse effects. Additionally, tight bandaging of the area where the product is applied is not recommended.

Discontinue use if excessive skin irritation develops.

Warnings and Precautions

For external use only. This product is contraindicated in pregnant women and children under 12 years of age unless specifically directed by a healthcare professional.

Application should be avoided on wounds or damaged skin, and it is advised not to bandage the area tightly after application.

In the event of excessive skin irritation, the use of this product should be discontinued immediately. Should the condition worsen, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, it is imperative to discontinue use and consult a healthcare provider for further evaluation and guidance.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for use in pregnant women and children under 12 years of age unless directed by a healthcare professional. The product should not be applied to wounds or damaged skin, and it is advised not to bandage the area tightly after application.

In clinical practice, if excessive irritation of the skin develops, patients are advised to discontinue use immediately. Additionally, if the condition worsens, or if symptoms persist for more than 7 days or clear up and then recur within a few days, patients should stop using the product and consult a doctor.

It is crucial to keep this and all medications out of the reach of children to prevent accidental ingestion or misuse.

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 Rocainol Topical Analgesic (methyl salicylate, menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Rocainol Topical Analgesic.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication unless directed by a healthcare professional. It is essential for healthcare providers to evaluate the necessity and safety of treatment in this age group. Caution is advised when considering the use of this medication in children, and consultation with a doctor is recommended prior to administration.

Geriatric Use

There is no specific information regarding the use of Rocainol Topical Analgesic in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for efficacy and adverse effects is recommended in this population, given the lack of established guidelines for geriatric use.

Pregnancy

Pregnant patients should not use this medication unless directed by a healthcare professional. The safety of this medication during pregnancy has not been established, and its use is contraindicated in this population. Additionally, the medication is not recommended for children under 12 years of age unless specifically prescribed by a physician. Healthcare providers should carefully consider the potential risks and benefits before prescribing this medication to pregnant patients.

Lactation

Lactating mothers should avoid the use of this medication unless directed by a healthcare professional. There is no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is advised when considering its use in lactating individuals.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose scenario.

Nonclinical Toxicology

The use of this product is contraindicated in pregnant women and children under 12 years of age unless specifically directed by a healthcare professional. In cases of excessive skin irritation, it is advised to discontinue use immediately.

No relevant information is available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available for the product associated with SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep this and all medications out of the reach of children to prevent accidental ingestion. Patients should be informed that if their condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, they should discontinue use of the product and consult a doctor.

It is important to communicate that this product should not be used by pregnant women and children under 12 years of age unless directed by a healthcare professional. Patients should also be cautioned to discontinue use if they experience excessive irritation of the skin.

Additionally, healthcare providers should instruct patients not to apply the product to wounds or damaged skin and to avoid bandaging the area tightly after application.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

Patients should apply the medication to the affected area no more than 3 or 4 times daily. This dosage is applicable for adults and children aged 12 years and older. For children under 12 years of age, it is advised to consult a doctor before use.

Drug Information (PDF)

This file contains official product information for Rocainol Topical Analgesic, 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 Rocainol Topical Analgesic, 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.