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Calypxo Pain Relief

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Active ingredients
  • Menthol 3 g/100 g
  • Methyl Salicylate 10 g/100 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 2014
Label revision date
October 16, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 3 g/100 g
  • Methyl Salicylate 10 g/100 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 2014
Label revision date
October 16, 2023
Manufacturer
Asclemed USA, Inc
Registration number
M017
NDC root
76420-450
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

Calypxo is a pain relief cream designed to provide temporary relief from minor aches and pains. It can be used for various conditions, including simple backaches, arthritis, bruises, sprains, and cramps. This cream is formulated to help soothe discomfort, making it a convenient option for those seeking relief from everyday pain.

Uses

If you're dealing with minor aches and pains, this medication can help provide temporary relief. It's effective for discomfort related to simple backaches, arthritis, bruises, sprains, and cramps.

You can rely on it to ease those everyday pains, allowing you to get back to your regular activities with less discomfort. Remember, it's designed for short-term use to help you feel better when you need it most.

Dosage and Administration

You should apply the medication directly to the area that is affected. This means you can use it on the specific spot where you are experiencing symptoms. You can repeat this application as needed throughout the day, but be careful not to use it more than 3 to 4 times daily. This will help ensure you get the best results while minimizing the risk of any potential side effects.

What to Avoid

It's important to be cautious when considering this medication. If you are pregnant or breastfeeding, you should contact your physician before using it to ensure it's safe for you and your baby.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always prioritize your health and consult with a healthcare professional if you have any concerns.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid getting it in your eyes or on mucous membranes, and do not cover the treated areas tightly or use it with a heating pad. You should also refrain from applying it to open wounds or damaged skin.

Some users may experience a mild burning sensation, which is generally normal. However, if you feel a severe burning sensation, stop using the product right away. If your symptoms last longer than seven days, please consult your physician for further advice.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or any mucous membranes. It's important not to tightly bandage or cover the areas where you apply the product, and you should also avoid using it with a heating pad. Do not apply it to open wounds or damaged skin.

You may experience a mild burning sensation, but if the burning becomes severe, stop using the product right away. If your symptoms last more than seven days, please discontinue use and consult your doctor. Keep this product out of reach of children, and if it is swallowed, seek medical advice immediately. If you are pregnant or breastfeeding, be sure to talk to your doctor before using this product.

Overdose

If you or someone you know has swallowed too much of this medication, it’s important to consult a physician right away. Overdosing can lead to serious health issues, and getting professional help is crucial.

Signs of an overdose may include unusual symptoms that could affect your breathing or overall well-being. If you notice any concerning changes, don’t hesitate to seek immediate medical attention. Remember, it’s always better to be safe and get checked by a healthcare professional.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to contact your physician before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you make the safest choices for you and your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to talk to your doctor before using this medication. Consulting with your healthcare provider can help ensure that you and your baby remain safe and healthy while considering any potential risks associated with the medication. Always prioritize open communication with your physician regarding your health and breastfeeding.

Pediatric Use

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should contact a physician immediately for guidance. Always ensure that medications are stored safely to prevent any accidental ingestion. Your vigilance can help keep your child safe.

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 considering this medication, it’s important to consult with a healthcare provider. 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall 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 tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, tailored specifically to your health needs.

Always keep your healthcare provider informed about any changes in your medication or health status. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep the product in a clean environment to ensure it remains safe for use. If you have any questions about proper handling or storage, don’t hesitate to reach out for guidance.

Additional Information

You should apply this medication directly to the affected area, using it no more than 3-4 times a day as needed. Remember, it is for external use only, so avoid contact with your eyes and mucous membranes. Do not tightly bandage or cover the treated areas, and refrain from using it with a heating pad. It's important not to apply it to open wounds or damaged skin.

You may experience a mild burning sensation, but if it becomes severe, stop using the product right away. If your symptoms last longer than seven days, consult your physician. Keep this medication out of reach of children, and if swallowed, seek medical advice. If you are pregnant or breastfeeding, talk to your doctor before using it.

FAQ

What is Calypxo?

Calypxo is a pain relief cream used for temporary relief of minor aches and pains associated with conditions like backaches, arthritis, bruises, sprains, and cramps.

How should I use Calypxo?

For adults, apply Calypxo directly to the affected area. You can repeat the application as necessary, but do not use it more than 3-4 times daily.

Are there any warnings I should be aware of?

Yes, Calypxo is for external use only. Avoid contact with eyes and mucous membranes, do not bandage tightly, and do not apply to open wounds or damaged skin.

What should I do if I experience a burning sensation?

A mild burning sensation may occur, but if you experience a severe burning sensation, you should discontinue use immediately.

Can I use Calypxo if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should contact your physician prior to using Calypxo.

What should I do if symptoms persist?

If your symptoms persist for more than seven days, you should discontinue use and consult your physician.

How should I store Calypxo?

Store Calypxo at room temperature and keep it out of reach of children. If swallowed, consult a physician.

Are there any contraindications for using Calypxo?

No specific contraindications are mentioned for Calypxo in the provided information.

Packaging Info

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

Packaging configurations for Calypxo Pain Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Calypxo is a pain relief cream formulated for topical application. Each container contains 4 ounces (113 grams) of the product. It is distributed by Enovachem Pharmaceuticals, located in Torrance, California, with the contact number (310) 320-0100. The product is identified by the National Drug Code (NDC) 76420-450-12.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with simple backaches, arthritis, bruises, sprains, and cramps.

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

Dosage and Administration

For adults, the medication should be applied directly to the affected area. The application may be repeated as necessary; however, it is important not to exceed a maximum frequency of 3 to 4 times daily. Care should be taken to ensure that the application is performed in accordance with the recommended dosing intervals to avoid potential overuse.

Contraindications

Use is contraindicated in individuals who are pregnant or breastfeeding without prior consultation with a physician.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes and mucous membranes to prevent irritation or injury. The treated areas should not be bandaged tightly or covered, as this may lead to adverse effects. Additionally, the application of heat, such as with a heating pad, is contraindicated.

This product should not be applied to open wounds or damaged skin, as this may exacerbate irritation or lead to complications. Users may experience a mild burning sensation upon application; however, if a severe burning sensation occurs, use should be discontinued immediately. Should symptoms persist for more than seven days, it is advised to discontinue use and consult a physician for further evaluation.

To ensure safety, this product must be kept out of reach of children. In the event of accidental ingestion, immediate consultation with a physician is necessary. Pregnant or breastfeeding individuals should contact their physician prior to use to discuss potential risks and benefits.

Side Effects

Patients using this product should be aware that it is intended for external use only. Care should be taken to avoid contact with the eyes and mucous membranes, as this may lead to irritation. Additionally, patients are advised not to bandage tightly or cover treated areas, and the use of heating pads in conjunction with this product is contraindicated.

Adverse reactions may include a mild burning sensation upon application. Should a severe burning sensation occur, patients are instructed to discontinue use immediately. If symptoms persist for more than seven days, it is recommended that patients consult a physician for further evaluation and guidance.

Patients should also refrain from applying the product to open wounds or damaged skin to prevent potential complications.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Calypxo Pain Relief.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, it is important to consult a physician immediately.

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 contact their physician prior to using this medication. It is essential for healthcare providers to evaluate the potential risks and benefits associated with the use of this medication during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure optimal fetal outcomes.

Lactation

Lactating mothers are advised to contact their physician prior to using this medication. There is no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating patients.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 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 that healthcare professionals take immediate action. If the product is ingested, the first step is to consult a physician for further evaluation and guidance.

Potential symptoms of overdosage may vary depending on the specific circumstances and the amount ingested. It is crucial for healthcare providers to monitor the patient closely for any adverse effects that may arise.

Management of overdosage should be tailored to the individual case, taking into account the patient's medical history and the specifics of the overdosage incident. Prompt medical intervention is essential to mitigate any potential risks associated with the overdosage.

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 the medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to consult a physician immediately for further guidance.

Additionally, it is important for healthcare providers to discuss the implications of the medication for patients who are pregnant or breastfeeding. Patients should be encouraged to contact their physician prior to using the medication to ensure safety for both themselves and their child.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted, ensuring straightforward management within standard storage conditions.

Additional Clinical Information

For adults, the medication should be applied directly to the affected area, with a maximum frequency of 3-4 times daily as needed. It is intended for external use only, and patients should avoid contact with eyes and mucous membranes. Clinicians should advise patients not to bandage tightly or cover treated areas, and to refrain from using heating pads in conjunction with the treatment. The medication should not be applied to open wounds or damaged skin.

Patients may experience a mild burning sensation; however, if a severe burning sensation occurs, they should discontinue use immediately. If symptoms persist for more than seven days, patients are advised to stop using the product and consult a physician. It is important to keep the medication out of reach of children, and if swallowed, to seek medical attention. Pregnant or breastfeeding patients should contact their physician prior to use.

Drug Information (PDF)

This file contains official product information for Calypxo Pain Relief, 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 Calypxo Pain Relief, 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.