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Coolexa

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Active ingredients
  • Menthol, Unspecified Form 100 mg/1 g
  • Camphor (synthetic) 40 mg/1 g
  • Methyl Salicylate 300 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 2025
Label revision date
November 6, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol, Unspecified Form 100 mg/1 g
  • Camphor (synthetic) 40 mg/1 g
  • Methyl Salicylate 300 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 2025
Label revision date
November 6, 2025
Manufacturer
Rising Pharma Holdings, Inc.
Registration number
M017
NDC root
57237-351
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Coolexa™ is a topical analgesic cream designed to provide temporary relief from minor aches and pains in muscles and joints. It contains key ingredients such as camphor, menthol, and methyl salicylate, which work together to soothe discomfort associated with conditions like simple backache, arthritis, strains, bruises, and sprains.

This ultra-strength cream is easy to apply and is intended for use on the skin, making it a convenient option for those seeking relief from everyday muscle and joint pain.

Uses

You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. It is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains. This means if you're dealing with discomfort from any of these issues, this medication may help ease your pain and improve your mobility.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

It's important to use this medication only as directed by your healthcare provider. If you are an adult or a child aged 12 years and older, you can apply it to the affected area up to 3 to 4 times a day. Make sure to follow the recommended frequency to ensure safety and effectiveness.

If the patient is a child under 12 years old, it's best to consult a doctor before use. They can provide guidance on the appropriate dosage and application for younger patients. Always prioritize safety and follow the advice of a healthcare professional.

What to Avoid

You should avoid using this product on any wounds or damaged skin, as it can cause further irritation or complications. Additionally, do not apply it with a heating pad or any external heat source, as this can increase the risk of side effects. If you are considering using this product for a child under 12 years old who has arthritis-like conditions, please refrain from doing so.

While using this product, be careful to avoid contact with your eyes or mucous membranes, as this can lead to discomfort or injury. It's also important not to bandage the area tightly, as this may restrict blood flow and cause additional issues. Always prioritize safety and follow these guidelines to ensure effective and safe use.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it and consult a doctor if your condition worsens, if symptoms persist for more than 7 days, if symptoms clear up and then return within a few days, or if you experience excessive skin irritation. Additionally, avoid using the product on wounds or damaged skin, and do not apply it with a heating pad or any external heat.

If you notice redness over the affected area, it's advisable to ask a doctor before continuing use. Remember to keep the product out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds or damaged skin. Do not use it with a heating pad or any external heat source, and it is not recommended for children under 12 years of age who have arthritis-like conditions. If you notice redness over the affected area, consult your doctor before using the product.

While using this product, be careful to avoid contact with your eyes or mucous membranes, and do not wrap the area tightly with a bandage. If your condition worsens, symptoms last longer than 7 days, or if you experience excessive skin irritation, stop using the product and contact your doctor. Additionally, if symptoms improve and then return within a few days, reach out to your healthcare provider. Always keep this product out of reach of children, and if swallowed, seek 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 seek medical help immediately. 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 right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

There is currently no specific information available regarding the use of COOLEXA (a cream containing camphor, menthol, and methyl salicylate) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor about any medications or treatments you are considering during this time.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. This means that, according to the information available, it is considered safe for you to use without concerns about potential effects on your milk production or the nursing infant.

Additionally, there are no indications that this product is excreted in breast milk, which further supports its safety during lactation. Always consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

Pediatric Use

If your child is under 12 years old and has arthritis-like conditions, it's important not to use this medication. For children in this age group, you should consult a doctor before use.

For those aged 12 and older, you can apply the medication to the affected area, but be sure to limit applications to no more than 3 to 4 times a day. Always follow your healthcare provider's guidance to ensure safe and effective use.

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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 should be used if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that your overall treatment plan is safe and effective.

Always discuss any other medications, supplements, or health conditions you have, as this information is crucial for your safety and well-being. Your provider can guide you on how to manage your health effectively.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). This temperature range helps maintain the product's effectiveness. Always check the Lot Number and Expiration Date, which can be found on the box or the crimp of the tube, to ensure you are using a valid and safe product.

When handling the product, make sure to do so with clean hands and in a clean environment to avoid contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times daily if you are an adult or a child aged 12 years and older. If the patient is under 12 years old, it's important to consult a doctor before use. Always follow the recommended application guidelines for safe and effective treatment.

FAQ

What is Coolexa™?

Coolexa™ is a topical analgesic cream designed to temporarily relieve minor aches and pains of muscles and joints.

What are the key ingredients in Coolexa™?

The key ingredients in Coolexa™ are Camphor, Menthol, and Methyl Salicylate in concentrations of 4%, 10%, and 30%.

What conditions does Coolexa™ help relieve?

Coolexa™ helps relieve minor aches and pains associated with simple backache, arthritis, strains, bruises, and sprains.

How should I use Coolexa™?

Apply Coolexa™ to the affected area not more than 3 to 4 times daily for adults and children 12 years and older. For children under 12, consult a doctor.

Are there any contraindications for using Coolexa™?

Do not use Coolexa™ on wounds or damaged skin, with a heating pad, or on children under 12 years of age with arthritis-like conditions.

What should I do if I experience side effects?

Stop using Coolexa™ and consult a doctor if your condition worsens, symptoms persist for more than 7 days, or if excessive skin irritation occurs.

Is Coolexa™ safe to use during pregnancy or while nursing?

The provided information does not specify safety concerns or recommendations for use during pregnancy or lactation.

What precautions should I take when using Coolexa™?

Avoid contact with eyes or mucous membranes, do not bandage tightly, and keep out of reach of children.

What should I do if Coolexa™ is swallowed?

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

Packaging Info

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

Packaging configurations for Coolexa.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

The medication should be used only as directed. For adults and children aged 12 years and older, it is recommended to apply the product to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a physician before use.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to wounds or damaged skin due to the risk of exacerbating the condition or causing irritation. Additionally, the application of external heat, such as with a heating pad, is contraindicated as it may lead to increased risk of burns or adverse reactions.

This product is also contraindicated for use in children under 12 years of age who present with arthritis-like conditions, as safety and efficacy have not been established in this population.

Furthermore, contact with eyes or mucous membranes should be avoided to prevent irritation. Tight bandaging is not recommended during use, as it may impede circulation and lead to complications.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin. It should not be used in conjunction with a heating pad or any external heat sources. Additionally, it is not recommended for use on children under 12 years of age who present with arthritis-like conditions.

Healthcare professionals should advise patients to consult a physician prior to use if there is any redness present over the affected area. During application, it is crucial to avoid contact with the eyes or mucous membranes, and patients should refrain from tightly bandaging the treated area.

Patients must be instructed to discontinue use and seek medical advice if any of the following occur: the condition worsens or symptoms persist beyond 7 days; symptoms resolve only to reappear within a few days; or if excessive skin irritation develops.

It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware of several important safety considerations. The product is intended for external use only and should not be applied to wounds or damaged skin. Additionally, it should not be used in conjunction with a heating pad or any external heat sources. Special caution is advised for children under 12 years of age with arthritis-like conditions, as the product is not recommended for this population.

Before using the product, patients should consult a healthcare professional if there is any redness over the affected area. While using the product, it is crucial to avoid contact with the eyes or mucous membranes and to refrain from tightly bandaging the area of application.

Patients are advised to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, if symptoms resolve and then recur within a few days, or if excessive skin irritation occurs. Furthermore, the product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Coolexa.
Details

Pediatric Use

Pediatric patients under 12 years of age with arthritis-like conditions should not use this medication. For children in this age group, it is advised to consult a healthcare professional before use.

For adolescents aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of COOLEXA (camphor, 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 pregnant patients, as the potential risks and effects on fetal outcomes are not well characterized. Women of childbearing potential should be advised to consult their healthcare provider before using this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any effects on breastfed infants.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: skin irritation, allergic reactions, and contact dermatitis. These events have been documented in the context of routine pharmacovigilance activities.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad or applying external heat. It is important to emphasize that this product should not be used on children under 12 years of age who have arthritis-like conditions.

Healthcare providers should counsel patients to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be advised to seek medical advice if symptoms resolve and then recur within a few days, or if they experience excessive skin irritation.

While using the product, patients should be cautioned to avoid contact with their eyes or mucous membranes. They should also be instructed not to bandage the area tightly. Finally, healthcare providers should recommend that patients consult a doctor before use if there is redness over the affected area.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F) to maintain its efficacy.

For traceability, the Lot Number and Expiration Date can be found on the box or the crimp of the tube. Proper handling and storage conditions are essential to ensure the integrity of the product throughout its shelf life.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years of age, it is advised to consult a doctor regarding the appropriate use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

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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.