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Sports Balm

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredients
  • Eucalyptus Oil 10 g/100 g
  • Menthol 8 g/100 g
  • Camphor (natural) 11 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 2016
Label revision date
June 4, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Eucalyptus Oil 10 g/100 g
  • Menthol 8 g/100 g
  • Camphor (natural) 11 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 2016
Label revision date
June 4, 2021
Manufacturer
Dr. Sankunni's Ayurvedic Research Foundation Private Limited
Registration number
part348
NDC root
70146-005
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

ZEN is an all-natural sports balm designed to help relieve aches and pains associated with various physical activities. It is particularly effective for conditions such as sports injuries, minor arthritis, sore muscles, leg cramps, and strains and sprains.

This balm offers a soothing option for those looking to ease discomfort from everyday activities or exercise-related issues. Whether you're an athlete or simply someone who experiences muscle tension, ZEN can provide the relief you need to stay active and comfortable.

Uses

ZEN is a natural sports balm designed to help relieve various aches and pains. You can use it for discomfort related to sports injuries, minor arthritis, sore muscles, leg cramps, and strains or sprains. Whether you're an athlete or just dealing with everyday muscle soreness, ZEN can provide the soothing relief you need.

Dosage and Administration

When using this medication, make sure to follow the instructions provided. You should apply it generously to the affected area three to four times a day for the best results. If you are considering using this medication for a child under 12 years old, it’s important to consult a doctor first to ensure it’s safe and appropriate for them.

What to Avoid

It's important to keep this medication out of reach of children to prevent accidental ingestion. If a child swallows it, seek medical help or contact a poison control center right away.

There are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this medication. However, always use it responsibly and as directed.

Side Effects

When using this product, it's important to remember that it is for external use only. You should stop using it if you experience excessive skin irritation. Avoid getting the product in your eyes or on mucous membranes, and do not apply tight bandages or use it with a heating pad.

If your condition worsens or symptoms last longer than 7 days, or if your symptoms improve and then return within a few days, you should consult a doctor. Additionally, discontinue use if you notice any excessive irritation of the skin.

Warnings and Precautions

This product is intended for external use only. While using it, you should stop immediately if you experience excessive skin irritation. Be careful to avoid contact with your eyes and any mucous membranes, and do not wrap the area tightly or use it with a heating pad.

If your condition worsens or symptoms last longer than 7 days, or if symptoms improve and then return within a few days, you should stop using the product and consult your doctor. Additionally, if you experience excessive skin irritation, it's important to seek medical advice.

In case of accidental swallowing, seek emergency medical help or contact a poison control center right away. Your safety is important, so please take these precautions seriously.

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, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to err on the side of caution when it comes to your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

The safety of this product during pregnancy has not been evaluated, so it's important to approach its use with caution. While there are no specific safety concerns or dosage modifications mentioned for pregnant individuals, the product is intended for external use only. This means that while it may not pose direct risks, you should still consider discussing its use with your healthcare provider to ensure it aligns with your individual health needs during pregnancy. Always prioritize your well-being and that of your baby when making decisions about any product.

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. Additionally, there are no known concerns about this product being passed into breast milk or any associated risks for your infant. Always consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If your child accidentally swallows it, seek medical help or contact a poison control center right away.

For children under 12 years old, you should consult a doctor before using this medication to ensure it's safe and appropriate for their age and health needs.

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 ensure that your healthcare provider is aware of any existing health conditions or medications, as this can help in making informed decisions about treatment options. Your safety and well-being are the top priority, so don’t hesitate to ask questions or express any concerns you may have.

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.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and appropriate for your kidney 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 monitor your liver function and determine the best approach for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need 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 important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. It's important to keep it out of reach of children to prevent any accidental ingestion. Once you open the product, be sure to discard it after use to maintain safety and hygiene. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply the medication generously to the affected area 3 to 4 times a day. It's important to keep this product out of reach of children to prevent accidental ingestion. If the medication is swallowed, seek medical help or contact a poison control center right away. If you are considering using this medication for a child under 12, consult a doctor first.

FAQ

What is ZEN?

ZEN is an all-natural sports balm used for relieving aches and pains.

What conditions is ZEN ideal for?

ZEN is ideal for aches and pains related to sports injuries, minor arthritis, sore muscles, leg cramps, and strains and sprains.

How should I use ZEN?

Apply ZEN generously to the affected area 3 to 4 times daily, and use only as directed.

Are there any warnings for using ZEN?

Yes, ZEN is for external use only. Discontinue use if excessive skin irritation occurs, and avoid contact with eyes and mucus membranes.

What should I do if I swallow ZEN?

If swallowed, get medical help or contact a poison control center immediately.

Is ZEN safe to use during pregnancy?

The safety of ZEN during pregnancy has not been evaluated, so caution is advised.

Can children use ZEN?

Children under 12 should consult a doctor before using ZEN.

How should ZEN be stored?

Store ZEN at room temperature and keep it out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Sports Balm (camphor, eucalyptus oil, menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sports Balm.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

ZEN is indicated for the relief of aches and pains associated with various conditions. This all-natural sports balm is specifically formulated for use in the following scenarios:

  • Aches and pains related to sports injuries

  • Minor arthritis

  • Sore muscles

  • Leg cramps

  • Strains and sprains

There are no teratogenic or nonteratogenic effects associated with ZEN.

Dosage and Administration

Healthcare professionals are advised to instruct patients to use the medication only as directed. The recommended application is to apply a generous amount to the affected area 3 to 4 times daily.

For pediatric patients under the age of 12, it is essential to consult a physician prior to use to ensure safety and appropriateness of treatment.

Contraindications

Use of this product is contraindicated in the following situations:

  • The product should be kept out of reach of children to prevent accidental ingestion. In the event of ingestion, immediate medical assistance or contact with a poison control center is required.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to discontinue use if excessive skin irritation develops. It is crucial to avoid contact with the eyes and mucous membranes, as this may lead to adverse effects. Additionally, patients should be instructed not to bandage the area tightly and to refrain from using the product in conjunction with a heating pad, as this may exacerbate irritation or cause other complications.

Patients should be closely monitored, and if any of the following conditions arise, they should be advised to stop use and consult a healthcare provider: if the condition worsens or symptoms persist for more than 7 days; if symptoms resolve and then recur within a few days; or if excessive skin irritation occurs.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a poison control center without delay. It is essential for healthcare professionals to ensure that patients are aware of these critical warnings and precautions to promote safe and effective use of the product.

Side Effects

Patients should be aware that this product is intended for external use only. It is important to discontinue use if excessive irritation of the skin develops. Additionally, contact with the eyes and mucous membranes should be avoided, and the product should not be applied with a tightly bandaged area or used in conjunction with a heating pad.

Patients are advised to stop using the product and consult a healthcare professional if their condition worsens or if symptoms persist for more than 7 days. They should also seek medical advice if symptoms clear up and then recur within a few days, or if excessive skin irritation occurs.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Sports Balm (camphor, eucalyptus oil, menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sports Balm.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children to prevent accidental ingestion. In the event of swallowing, immediate medical assistance or contact with a poison control center is advised. For children under 12 years of age, it is recommended to consult a healthcare professional prior to use.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The product has not been evaluated for safety during pregnancy. While no specific contraindications are mentioned, caution is advised as the product is intended for external use only. There are no documented safety concerns regarding the use of this product during pregnancy, and no dosage modifications for pregnant individuals are specified. Additionally, no special precautions regarding its use during pregnancy are outlined. Healthcare professionals should consider the lack of safety data and exercise clinical judgment when recommending this product to pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

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 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, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include airway management, monitoring of vital signs, and intravenous fluid administration as necessary.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes that may be applicable based on the clinical scenario.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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. It is important for patients to understand the potential risks associated with the medication and to take necessary precautions to ensure safety in their home environment.

In the event that the medication is swallowed, healthcare providers should instruct patients to seek medical help or contact a poison control center immediately. Emphasizing the importance of prompt action in such situations can help mitigate potential health risks.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature to maintain its efficacy. To ensure safety, it is imperative to keep the product out of reach of children to prevent accidental ingestion. Additionally, the product must be discarded after opening to ensure proper safety and effectiveness.

Additional Clinical Information

The medication is administered topically, with a recommended application of a generous amount to the affected area 3 to 4 times daily. Clinicians should advise patients to keep the product out of reach of children to prevent accidental ingestion. In the event of swallowing, patients should seek medical assistance or contact a poison control center immediately. Additionally, it is important for patients to consult a doctor before use if they are under 12 years of age.

Drug Information (PDF)

This file contains official product information for Sports Balm, 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 Sports Balm, 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.