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Womens Sports Balm

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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
70146-007
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 a topical balm designed to help relieve aches and pains, particularly those associated with sports injuries, minor arthritis, sore muscles, leg cramps, and strains and sprains. Infused with lavender oil, this product is tailored for women who are active in sports or simply looking for soothing relief from discomfort.

By applying ZEN to the affected areas, you can experience a calming effect that targets your pain, allowing you to continue enjoying your activities with greater ease.

Uses

ZEN is a medication designed to help relieve various types of 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 dealing with muscle soreness after a workout or the nagging pain of arthritis, ZEN can provide the relief you need to get back to your activities.

Dosage and Administration

It's important to use this medication only as directed by your healthcare provider. For best results, apply a generous amount to the affected area three to four times a day. This will help ensure that the medication works effectively to relieve your symptoms.

If you are considering this treatment for a child under 12 years old, be sure to consult a doctor before use. They can provide guidance on the appropriate dosage and ensure it's safe for your child.

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, controlled substance classifications, or concerns about abuse, misuse, or 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 your 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, reach out to your healthcare provider.

In case of accidental ingestion, 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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have concerns about an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that this product has not been evaluated for safety during pregnancy. While there are no specific contraindications listed, caution is advised because the active ingredients may pose risks. Currently, there is no detailed information available about potential risks to the fetus, and no dosage modifications or special precautions have been provided for pregnant individuals.

Given this uncertainty, it's best to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Your healthcare provider can help you weigh the potential benefits and risks based on your individual circumstances.

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 is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

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 the age of 12, you should consult a doctor before using this medication to ensure it is safe and appropriate for their specific needs. Always prioritize your child's safety and well-being when considering any medication.

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 keep in mind that older adults may have different responses to medications, so discussing any concerns with a doctor is essential for ensuring safety and effectiveness.

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 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 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 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, remember to discard it after use to maintain safety and hygiene. Following these 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 have a child under 12, consult a doctor before using this product.

FAQ

What is ZEN used for?

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

How should I apply ZEN?

You should apply ZEN generously to the affected area 3 to 4 times daily.

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.

Can children use ZEN?

Children under 12 should consult a doctor before use.

Is ZEN safe to use during pregnancy?

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

What should I do if my condition worsens while using ZEN?

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

How should I store ZEN?

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

Packaging Info

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

Packaging configurations for Womens Sports Balm.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product, identified by SPL Code 34089-3, is a formulation comprising both active and inactive ingredients. The active ingredients consist of specific active ingredients not provided in the text, while the inactive ingredients include specific inactive ingredients not provided in the text. This formulation is presented in specific dosage form not provided in the text. The physical characteristics of the product are described as specific physical characteristics not provided in the text. The chemical name of the active ingredient is specific chemical name not provided in the text.

Uses and Indications

This drug is indicated for the relief of aches and pains. It is particularly effective for conditions related to sports injuries, minor arthritis, sore muscles, leg cramps, cramps, and strains and sprains.

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

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 three to four 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

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of accidental swallowing, seek medical assistance or contact a poison control center immediately.

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 for any worsening of their condition or persistence of symptoms beyond 7 days. If symptoms resolve and then recur within a few days, or if excessive skin irritation occurs, it is imperative that the patient stops using the product and consults a healthcare provider for further evaluation.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a poison control center without delay. Prompt action is essential to ensure patient safety and mitigate potential risks associated with the ingestion of this product.

Side Effects

Patients should be aware that this product is intended for external use only. It is crucial 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 tight bandage 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

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 Womens Sports Balm (camphor, eucalyptus oil, menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Womens Sports Balm.
Details

Pediatric Use

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

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

The product has not been evaluated for safety during pregnancy. While specific contraindications are not mentioned, caution is advised due to the presence of active ingredients that may pose risks. Currently, there is no specific information available regarding potential risks to the fetus. Additionally, there are no dosage modifications recommended for pregnant individuals, nor are there any special precautions outlined for use during pregnancy. Healthcare professionals should weigh the potential benefits against the unknown risks when considering this product for pregnant patients.

Lactation

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

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular monitoring of renal function may be warranted in patients with reduced kidney function to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available regarding 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.

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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management and follow-up care.

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 to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize the potential risks associated with ingestion by children.

In the event that the medication is swallowed, healthcare providers should instruct patients to seek medical help or contact a poison control center immediately. This prompt action is crucial for ensuring the safety and well-being of the patient.

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 prevent accidental ingestion, it is essential to keep the product out of reach of children. Additionally, once opened, the product must be discarded to ensure safety and integrity.

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 with children under 12 years of age to consult a doctor prior to use.

Drug Information (PDF)

This file contains official product information for Womens 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 Womens 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

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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.