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Calorub

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Active ingredients
  • Menthol, Unspecified Form 59.1 mg/1 g
  • Methyl Salicylate 128 mg/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
July 2, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol, Unspecified Form 59.1 mg/1 g
  • Methyl Salicylate 128 mg/1 g
Other brand names
Dosage form
Cream
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 2018
Label revision date
July 2, 2018
Manufacturer
The Mentholatum Company
NDC root
10742-2120
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

Mentholatum Calorub is a topical medication that is commonly used to relieve minor aches and pains in muscles and joints. It typically contains menthol, which provides a cooling sensation that can help soothe discomfort. This product is often applied directly to the skin in the affected area, offering a convenient way to manage pain without the need for oral medications.

If you're looking for a way to ease muscle or joint pain, Mentholatum Calorub may be a helpful option to consider. Always remember to follow the instructions for use to ensure safety and effectiveness.

Uses

Mentholatum Calorub is designed to provide temporary relief from minor aches and pains in your muscles and joints. Whether you're dealing with discomfort from physical activity or everyday strains, this product can help soothe those bothersome sensations.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this product. This makes it a safe option for many individuals seeking relief from muscle and joint discomfort.

Dosage and Administration

When using this medication, you will apply it directly to your skin, as it is designed for topical (applied to the skin) use. Each gram of the product contains 59.1 mg of menthol and 128 mg of methyl salicylate. These active ingredients work together to provide relief from discomfort.

Make sure to follow the instructions provided by your healthcare professional regarding how often to apply the medication. It's important to use it as directed to ensure you get the best results. Always wash your hands after applying the product to avoid any irritation to your eyes or other sensitive areas.

What to Avoid

It's important to be aware of certain precautions when considering medication. While specific contraindications (conditions or factors that serve as reasons to withhold a certain medical treatment) and details about controlled substances are not provided, you should always consult with your healthcare provider about your medical history and any other medications you are taking.

Additionally, be cautious about the potential for abuse or misuse, which refers to using a medication in a way not intended by the prescribing doctor. Dependence (a condition where the body becomes reliant on a substance) can also be a concern with some medications. Always follow your healthcare provider's instructions and never take or use medication without their guidance.

Side Effects

You may experience some side effects while using this medication. Common reactions include allergic symptoms such as rash, itching, redness, and swelling. You might also notice skin irritation, burning, or stinging sensations. Gastrointestinal issues like nausea and vomiting can occur, along with neurological effects such as headaches and dizziness. Respiratory symptoms may include difficulty breathing and wheezing, while cardiovascular effects can manifest as an increased heart rate or palpitations.

It's important to be aware that severe allergic reactions, known as anaphylaxis (a serious and potentially life-threatening reaction), have been reported. If you have sensitive skin or a history of allergies to menthol or methyl salicylate, use this medication with caution.

Warnings and Precautions

You can feel reassured that there are no specific warnings or precautions associated with this medication based on the information provided. This means that, as of now, there are no known risks or necessary precautions to be aware of while using it.

Since there are no required laboratory tests or emergency instructions mentioned, you can use this medication without the need for regular monitoring or immediate medical intervention. However, if you ever feel uncertain or experience any unusual symptoms, it’s always a good idea to consult your doctor for personalized advice.

Overdose

Taking too much CALORUB can lead to serious health issues. If you or someone you know has taken an overdose, it’s important to be aware of the symptoms, which may include nausea (feeling sick), vomiting, and abdominal pain (discomfort in the stomach area).

If you suspect an overdose, seek medical attention immediately. It’s always better to be safe and get help as soon as possible. Remember, your health is the top priority.

Pregnancy Use

When considering the use of CALORUB (a cream containing menthol and methyl salicylate) during pregnancy, it's important to note that there is no specific information available about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this product on you or your developing baby are not well understood.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any medication or topical treatment. They can help you weigh the potential risks and benefits based on your individual circumstances.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that the information available does not provide clear insights into how breastfeeding may be affected or any potential risks involved.

If you have concerns about breastfeeding while taking certain medications or treatments, it's always best to consult with your healthcare provider for personalized advice and support. They can help you understand any implications for you and your baby.

Pediatric Use

It's important to know that the use of CALORUB menthol and methyl salicylate cream in children has not been established. This means that there is no clear information on whether it is safe or effective for kids. As a parent or caregiver, you should be cautious and consult with a healthcare professional before using this product on children, as the safety and effectiveness in pediatric patients have not been determined. Always prioritize your child's health and well-being by seeking expert advice.

Geriatric Use

While there is no specific information about the use of CALORUB (menthol, methyl salicylate cream) in older adults, it’s always important to approach any new treatment 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 help ensure that it’s appropriate for your needs and discuss any potential interactions with other medications you may be taking.

As you consider using CALORUB, keep in mind that older adults may have different sensitivities to medications and topical treatments. Always monitor for any unusual reactions and report them to your doctor.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert for CALORUB (a cream containing menthol and methyl salicylate) does not provide specific information about dosage adjustments or special monitoring for patients with renal impairment. This means that there are no established guidelines or safety considerations outlined for individuals with kidney issues when using this product.

Before using CALORUB, it’s a good idea to consult with your healthcare provider to ensure it’s safe for you, especially if you have any concerns about your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert for CALORUB (a cream containing menthol and methyl salicylate) does not provide specific information about how liver impairment might affect its use. This means there are no recommended dosage adjustments, special monitoring, or precautions outlined for patients with liver conditions.

As always, it's best to consult with your healthcare provider before using any new medication, especially if you have liver issues, to ensure it is safe for you.

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 and share any concerns you may have about your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, away from excessive heat. It's important to keep the tube tightly closed when not in use to maintain its integrity. Please avoid freezing the product, as this can affect its effectiveness. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Mentholatum Calorub used for?

Mentholatum Calorub is indicated for the temporary relief of minor aches and pains of muscles and joints.

How should I apply Mentholatum Calorub?

Apply a thin layer of CALORUB cream to the affected area and gently massage until fully absorbed. Use as needed.

What are the active ingredients in Mentholatum Calorub?

The active ingredients are Menthol (59.1 mg in 1 g) and Methyl Salicylate (128 mg in 1 g).

What are some possible side effects of using Mentholatum Calorub?

Possible side effects include rash, itching, redness, swelling, burning sensation, stinging, nausea, headache, and difficulty breathing. Severe allergic reactions have also been reported.

Is Mentholatum Calorub safe to use during pregnancy?

There is no specific information regarding the safety of Mentholatum Calorub during pregnancy.

Can I use Mentholatum Calorub if I am nursing?

There are no specific statements regarding the use of Mentholatum Calorub for nursing mothers.

How should I store Mentholatum Calorub?

Store at room temperature, protect from excessive heat, do not freeze, and keep the tube tightly closed when not in use.

Is Mentholatum Calorub safe for children?

Pediatric use has not been established, and safety and effectiveness in pediatric patients have not been determined.

Are there any contraindications for using Mentholatum Calorub?

No specific contraindications are mentioned in the provided text.

Packaging Info

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

Packaging configurations for Calorub.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Mentholatum Calorub is a topical formulation designed for the relief of minor muscle and joint pain. The active ingredient is menthol, which provides a cooling sensation upon application. The product is presented in an ointment dosage form, characterized by its semi-solid consistency. It is typically packaged in a convenient container for ease of use. The formulation is designed to penetrate the skin, delivering localized relief to affected areas.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints.

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

Dosage and Administration

The product is intended for topical administration. Each gram of the formulation contains 59.1 mg of menthol and 128 mg of methyl salicylate.

For optimal results, the healthcare professional should instruct patients to apply the product directly to the affected area of the skin. The application should be performed as needed, ensuring that the area is clean and dry prior to use.

It is recommended to use a sufficient amount of the product to cover the affected area adequately. Care should be taken to avoid contact with eyes and mucous membranes. If irritation occurs, the application should be discontinued, and appropriate measures should be taken.

Patients should be advised to wash their hands thoroughly after application to prevent accidental transfer of the product to sensitive areas.

Contraindications

There are no specified contraindications for the use of this product. Healthcare professionals should assess individual patient circumstances and consider any relevant clinical guidelines or patient-specific factors when determining the appropriateness of use.

Warnings and Precautions

There are currently no specific warnings or precautions associated with the use of this medication. Healthcare professionals are advised to remain vigilant and monitor patients as necessary, although no particular laboratory tests or emergency protocols have been outlined in the provided information.

In the absence of specified warnings, it is essential for healthcare providers to exercise clinical judgment and consider individual patient circumstances when prescribing this medication. Regular follow-up and assessment of patient response may be prudent to ensure safe and effective use.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions include severe allergic reactions, such as anaphylaxis, which have been reported in some cases.

Common adverse reactions observed in clinical trials and postmarketing experiences include:

Allergic Reactions: Patients may present with rash, itching, redness, and swelling.

Dermatologic Reactions: Participants have reported sensations of burning and stinging, as well as general skin irritation.

Gastrointestinal Reactions: Nausea and vomiting have been noted among subjects.

Neurological Reactions: Headache and dizziness are also common complaints.

Respiratory Reactions: Some patients may experience difficulty breathing and wheezing.

Cardiovascular Reactions: Increased heart rate and palpitations have been documented.

It is important to use this medication with caution in patients who have sensitive skin or known allergies to menthol or methyl salicylate, as these individuals may be at a higher risk for adverse reactions.

Drug Interactions

No specific drug interactions have been identified for the product. 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 Calorub (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Calorub.
Details

Pediatric Use

Pediatric use of CALORUB menthol, methyl salicylate cream has not been established. The safety and effectiveness of this product in pediatric patients remain undetermined. Therefore, caution is advised when considering its use in children.

Geriatric Use

There is no specific information regarding the use of CALORUB (menthol, methyl salicylate cream) in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when administering this product to elderly patients, as the absence of data does not preclude the potential for age-related differences in drug metabolism and response. Monitoring for efficacy and adverse effects is advisable in this population.

Pregnancy

There is no information available regarding the use of CALORUB (menthol, methyl salicylate cream) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential and during pregnancy, given the lack of data on potential fetal impacts. It is advisable to weigh the benefits against any unknown risks when recommending this product to pregnant patients.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or during lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its effects on breastfed infants. Healthcare professionals should consider the lack of information when advising lactating mothers about the use of this medication.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the drug insert for CALORUB (menthol, methyl salicylate cream). Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to CALORUB (menthol, methyl salicylate cream). The prescribing information does not provide any dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. Therefore, healthcare professionals should exercise caution when considering the use of this product in patients with hepatic impairment, as the effects in this population are not well characterized.

Overdosage

Overdosage of CALORUB may lead to significant adverse effects that require prompt medical intervention.

Symptoms Healthcare professionals should be aware that symptoms associated with overdosage can include nausea, vomiting, and abdominal pain. These manifestations may vary in severity and can indicate the need for immediate medical evaluation.

Recommended Actions In the event of suspected overdosage, it is imperative to seek medical attention without delay. Timely intervention is crucial to manage the potential complications associated with CALORUB overdosage effectively.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that the product is intended for external use only. Patients should be instructed to avoid contact with the eyes; in the event of contact, they should rinse the eyes thoroughly with water.

It is important to inform patients not to apply the product to broken or irritated skin. Additionally, they should be cautioned against bandaging the area tightly after application to prevent any adverse effects.

Patients should be reminded to wash their hands after applying the product, unless they are treating their hands. They should also be made aware that if their condition worsens or does not improve within 7 days of use, they should discontinue use and consult a physician for further evaluation.

Finally, healthcare providers should emphasize the importance of keeping the product out of reach of children. In the case of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately.

Storage and Handling

The product is supplied in a tube that must be kept tightly closed when not in use. It should be stored at room temperature, ensuring protection from excessive heat. Freezing is not permitted, as it may compromise the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Calorub, 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 Calorub, 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.