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Astonea Care Muscle and Join Pain Relief Cream

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This product has been discontinued

Active ingredients
  • Menthol, Unspecified Form 100 mg/1 g
  • Methyl Salicylate 150 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 2024
Label revision date
March 5, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol, Unspecified Form 100 mg/1 g
  • Methyl Salicylate 150 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 2024
Label revision date
March 5, 2024
Manufacturer
ASTONEA LABS PRIVATE LIMITED
Registration number
M017
NDC root
77338-212
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

Muscle & Joint Pain Relief Cream is a topical product designed to temporarily relieve minor aches and pains associated with muscles and joints. You can use it for conditions such as simple backache, arthritis, strains, bruises, and sprains. This cream works by targeting the discomfort directly at the site of pain, providing you with soothing relief when you need it most.

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 comfort.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

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 essential to consult a physician (doctor) before use. This will help ensure that the medication is appropriate and safe for younger patients. Always follow your healthcare provider's instructions for the best results.

What to Avoid

It's important to use this product safely. You should not apply it to wounds or any damaged skin, as this could lead to complications. Additionally, avoid using it in combination with a heating pad, as this may increase the risk of adverse 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, as it is not recommended for that age group. Always prioritize safety and consult a healthcare professional if you have any questions or concerns.

Side Effects

You may experience some side effects while using this product. If you notice excessive skin irritation, if your condition worsens, or if your symptoms last more than 7 days or return shortly after clearing up, stop using the product and consult a doctor. It's also important to ask a doctor before use if you have redness over the affected area.

This product is for external use only and should not be applied to wounds or damaged skin. Avoid using it with a heating pad, and do not apply it to children under 12 years of age with arthritis-like conditions. While using the product, keep it away from your eyes and mucous membranes, and avoid tight bandaging. Always keep it out of reach of children, and if swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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, and if the person using it is a child under 12 years old with arthritis-like conditions, consult a doctor first.

Before using this product, check with your doctor if you notice any redness over the affected area. While using it, be careful to keep it away from your eyes and mucous membranes, and avoid wrapping the area too tightly. If you experience excessive skin irritation, if your condition worsens, or if symptoms last more than 7 days or return shortly after improvement, stop using the product and contact your doctor.

Always keep this product out of reach of children. If swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, but specific details about these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, you may be wondering about the safety of using ASTONEA CARE Muscle and Joint Pain Relief Cream. The good news is that there are no specific warnings, precautions, or contraindications associated with its use during pregnancy. This means that, based on current information, it is considered safe for you to use this cream for muscle and joint pain relief while you are expecting.

However, it's always a good idea to consult with your healthcare provider before using any new product during pregnancy to ensure it aligns with your individual health needs.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your physician before using this product. There is a possibility that it may be excreted in breast milk, and the safety of this product during lactation has not been established. Therefore, exercising caution is advised when considering its use while nursing. Your healthcare provider can help you weigh the benefits and risks to ensure the best outcome for you and your baby.

Pediatric Use

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

For children aged 12 and older, you can apply the medication to the affected area, but make sure to do this no more than 3 to 4 times a day. Always follow your healthcare provider's advice to ensure safe and effective use.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

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 monitor your kidney function and make any necessary adjustments to 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 may affect you 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. In this case, there are no known interactions with other drugs or laboratory tests. 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 tests during your appointments.

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.

When handling the product, be cautious not to use it if the tube seal under the cap is broken, as this could compromise its safety and effectiveness. Always check the seal before use to ensure you are using a safe and intact product.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day 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 physician before use. There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What is Muscle & Joint Pain Relief Cream used for?

Muscle & Joint Pain Relief Cream temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

How should I use this cream?

Apply the cream to the affected area not more than 3 to 4 times daily for adults and children 12 years of age and over. Consult a physician for children under 12.

Are there any contraindications for using this cream?

There are no specified contraindications, but do not use on wounds or damaged skin, or with a heating pad.

What should I do if I experience excessive skin irritation?

Stop using the cream and ask a doctor if excessive skin irritation occurs, if the condition worsens, or if symptoms last more than 7 days.

Is this cream safe to use during pregnancy?

There are no specific warnings or contraindications regarding the use of this cream during pregnancy, but consult a physician for personalized advice.

Can nursing mothers use this cream?

Nursing mothers should consult a physician before using this product, as there is a potential for excretion in breast milk.

What should I do if the cream is swallowed?

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

What are the storage conditions for this cream?

Store the cream at 20° to 25°C (68° to 77°F) and do not use if the tube seal under the cap is broken.

Packaging Info

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

Packaging configurations for Astonea Care Muscle and Join Pain Relief Cream.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Muscle & Joint Pain Relief Cream is formulated for topical application to alleviate discomfort associated with muscle and joint pain. The product is designed for effective use as indicated by its principal display and drug fact panel, which can be referenced in the accompanying image (img_12ef23cc-1512-8de9-e063-6294a90a3314). The formulation is intended for use starting from the effective date of September 1, 2021.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it is effective for 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 prior to use to determine appropriate dosing and administration.

Contraindications

The product is contraindicated in the following situations:

  • Application on wounds or damaged skin is prohibited due to the potential for adverse effects.

  • Concurrent use with a heating pad is not recommended, as it may lead to increased risk of burns or skin irritation.

  • The product should not be used in children under 12 years of age with arthritis-like conditions, as safety and efficacy have not been established in this population.

Warnings and Precautions

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

Healthcare professionals should advise patients to consult a doctor 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 area.

Patients must be instructed to discontinue use and seek medical advice if excessive skin irritation occurs, if the condition worsens, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

This 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 at 1-800-222-1222.

Side Effects

Patients using this product may experience various adverse reactions. Serious reactions warrant immediate medical attention, particularly if excessive skin irritation occurs, the condition worsens, or symptoms persist for more than 7 days or resolve only to recur within a few days.

Common adverse reactions include localized redness over the affected area, which should prompt patients to consult a healthcare professional before continued use.

Warnings associated with this product emphasize that it is 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 on children under 12 years of age with arthritis-like conditions.

While using this product, patients are advised to avoid contact with eyes or mucous membranes and to refrain from tightly bandaging the area of application.

It is crucial to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Drug Interactions

No drug interactions have been identified for the product, indicating that it does not exhibit significant pharmacokinetic or pharmacodynamic interactions with other medications. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or enhanced monitoring are necessary when this product is used in conjunction with other therapies or diagnostic assessments.

Packaging & NDC

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

Packaging configurations for Astonea Care Muscle and Join Pain Relief Cream.
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 physician prior to 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

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

Pregnancy

The use of ASTONEA CARE Muscle and Joint Pain Relief Cream during pregnancy has not been associated with specific warnings, precautions, or contraindications. However, as with any medication, healthcare professionals should consider the potential risks and benefits when recommending this product to pregnant patients. It is advisable for women of childbearing potential to consult their healthcare provider before using this cream to ensure it aligns with their individual health needs and circumstances.

Lactation

Nursing mothers should consult a physician before using this product. There is a potential for excretion in breast milk, and the safety of this product during lactation has not been established. Caution is advised when using this product while breastfeeding.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. Contacting a Poison Control Center is recommended, with the national hotline available at 1-800-222-1222.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and initiate appropriate management procedures based on the severity of symptoms presented.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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 at 1-800-222-1222.

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. 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 discontinue use and consult a doctor if they experience excessive skin irritation, if their condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Patients should be reminded to avoid contact with eyes or mucous membranes while using this product. Additionally, they should not bandage the area tightly when applying the product. It is advisable for patients to consult a doctor before use if there is redness over the affected area.

Storage and Handling

The product is supplied in a tube format. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). It is imperative that the product is not used if the tube seal under the cap is broken, as this may compromise the integrity of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 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 physician prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Astonea Care Muscle and Join Pain Relief Cream, 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 Astonea Care Muscle and Join Pain Relief Cream, 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.