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Zpol Ultra

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Active ingredients
  • Menthol 2.84 g/100 g
  • Methyl Salicylate 18.24 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 2025
Label revision date
March 27, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 2.84 g/100 g
  • Methyl Salicylate 18.24 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 2025
Label revision date
March 27, 2025
Manufacturer
Laboratorios Zepol S. A.
Registration number
M017
NDC root
55715-008
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

Zpol ULTRA is a topical analgesic cream designed to provide temporary relief from minor aches and pains in muscles and joints. It is particularly effective for conditions such as simple backache, arthritis, strains, bruises, and sprains. This cream is also recommended for alleviating muscle pain, bumps, sprains, and sports injuries, making it a useful option for those seeking relief from discomfort associated with physical activity or joint issues.

Manufactured by Laboratorios Zepol in Costa Rica, Zpol ULTRA is intended for external use and is available over the counter. Its formulation targets pain relief directly at the site of discomfort, helping you manage everyday aches effectively.

Uses

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. This includes discomfort from simple backaches, arthritis, strains, bruises, and sprains. If you're dealing with muscle pain, bumps, sprains, or sports injuries, this medication is also recommended to help alleviate those issues. Additionally, it can provide relief from arthritic and rheumatic pain.

It's important to note that there are no teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects mentioned, making it a safer option for many individuals.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not apply it to wounds or damaged skin, as this can lead to irritation or complications. Additionally, avoid bandaging tightly over the area where you apply the product, and make sure to keep it away from your eyes to prevent discomfort. Lastly, do not use it in conjunction with a heating pad, as this could increase the risk of adverse effects. Following these guidelines will help ensure your safety while using the product.

Side Effects

When using this product, it's important to be aware of some precautions. It is meant for external use only, so avoid applying it to wounds or damaged skin, and do not bandage the area tightly. Be careful to keep it away from your eyes and do not use it with a heating pad.

If your condition worsens, or if symptoms last more than 7 days or return after clearing up, you should stop using the product and consult a doctor. If you are pregnant or breastfeeding, it's best to check with a healthcare professional before using it. Always keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to wounds or any damaged skin. It's important not to bandage the area tightly and to keep it away from your eyes. Additionally, do not use this product in combination with a heating pad, as this could lead to unwanted effects.

If your condition worsens, or if symptoms last longer than 7 days or return after clearing up, stop using the product and consult your doctor. In the event that the product is swallowed, seek medical help immediately or contact a Poison Control Center for assistance.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center. They can provide guidance on what to do next.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to reach out for help. Remember, it’s always better to be safe and get professional advice in these situations.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without first consulting a doctor. For children aged 2 years and older, you can apply the medication to the affected area, but be sure to do this no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

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 the drug insert does not provide guidelines tailored for elderly patients.

If you are caring for an older adult, it's important to consult with a healthcare professional for personalized advice, as they can help determine the best approach based on individual health needs and conditions. Always prioritize open communication with healthcare providers to ensure safe and effective use of any medication.

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 kidney function might affect the use of this medication.

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

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your liver 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 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 safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the product's quality.

When handling the product, be sure to check the seal under the cap. If the seal is broken or missing, do not use the product, as this indicates it may have been tampered with. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply the medication to the affected area no more than 3 to 4 times daily if you are an adult or a child aged 2 years and older. If the patient is under 2 years of age, it is important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is zpol ULTRA?

zpol ULTRA is a muscular topical analgesic cream used for the temporary relief of minor aches and pains of muscles and joints.

What conditions does zpol ULTRA help relieve?

It is recommended for relief from muscle pain, bumps, sprains, sports injuries, and arthritic and rheumatic pain.

How should I use zpol ULTRA?

Apply to the affected area not more than 3 to 4 times daily for adults and children 2 years of age and older. Do not use on children under 2 years without consulting a doctor.

Are there any warnings for using zpol ULTRA?

Yes, it is for external use only. Avoid applying to wounds or damaged skin, bandaging tightly, or using with a heating pad.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

Can I use zpol ULTRA if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before use.

What should I do if zpol ULTRA is swallowed?

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

Where is zpol ULTRA manufactured?

zpol ULTRA is manufactured by Laboratorios Zepol, S.A. in Curridabat, San José, Costa Rica.

How should I store zpol ULTRA?

Store zpol ULTRA between 20-25°C (68-77°F) and do not use if the seal under the cap is broken or missing.

Packaging Info

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

Packaging configurations for Zpol Ultra.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Zpol ULTRA is a muscular topical analgesic cream formulated for external use. It is manufactured by Laboratorios Zepol, S.A., located in Curridabat, San José, Costa Rica. The product is available in a net weight of 1.02 ounces and is classified as an over-the-counter medication. Zpol ULTRA Cream is indicated for the relief of muscle pain, bumps, sprains, and sports injuries, as well as for alleviating arthritic and rheumatic pain. The product is identified by the National Drug Code (NDC) 55715-008-01 and is a product of Costa Rica.

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. It is recommended for the relief of muscle pain, bumps, sprains, and sports injuries, as well as for alleviating arthritic and rheumatic pain.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the product should not be used without consulting a healthcare professional. It is essential to seek medical advice before administering this treatment to this age group.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for irritation and adverse effects. Tight bandaging is not recommended as it may impede circulation and exacerbate skin reactions. Contact with the eyes should be avoided to prevent irritation or injury. Additionally, the use of a heating pad in conjunction with this product is contraindicated, as it may lead to increased absorption and potential toxicity.

Warnings and Precautions

For external use only. It is imperative that the product is not applied to wounds or damaged skin to prevent adverse reactions. Healthcare professionals should advise patients against tightly bandaging the area where the product is applied, as this may lead to increased irritation or other complications.

Contact with the eyes must be avoided, as it can result in significant discomfort or injury. Additionally, the use of this product in conjunction with a heating pad is contraindicated, as it may enhance absorption and lead to potential toxicity.

Patients should be instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid applying the product to wounds or damaged skin, and to refrain from bandaging the area tightly. Contact with the eyes should be avoided, and the product should not be used in conjunction with a heating pad.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a doctor.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a health professional prior to use.

This product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Zpol Ultra (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Zpol Ultra.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication without consulting a doctor. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information available 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 consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information 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 there is no available data to guide dosing or monitoring in this population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

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 may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to address any complications that may arise.

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 seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

When using this product, patients should be informed of specific precautions. They should not apply the product to wounds or damaged skin, and they should avoid bandaging the area tightly. Additionally, patients should be cautioned to avoid contact with their eyes and to refrain from using the product in conjunction with a heating pad.

Storage and Handling

The product is supplied in a configuration that ensures tamper evidence. It is essential to inspect the seal under the cap before use; the product should not be utilized if the seal is broken or missing.

For optimal storage, the product must be maintained at a temperature range of 20-25°C (68-77°F). Proper adherence to these storage conditions is crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

For patients aged 2 years and older, the medication should be applied to the affected area no more than 3 to 4 times daily. It is contraindicated for use in children under 2 years of age, and clinicians are advised to consult a doctor in such cases. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Zpol Ultra, 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 Zpol Ultra, 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.