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Soundbody Medicated Patch

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This product has been discontinued

Active ingredients
  • Camphor (synthetic) 31 mg
  • Menthol 60 mg
  • Methyl Salicylate 100 mg
Other brand names
Dosage form
Patch
Routes
  • Percutaneous
  • Topical
  • Transdermal
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2002
Label revision date
February 17, 2023
Active ingredients
  • Camphor (synthetic) 31 mg
  • Menthol 60 mg
  • Methyl Salicylate 100 mg
Other brand names
Dosage form
Patch
Routes
  • Percutaneous
  • Topical
  • Transdermal
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2002
Label revision date
February 17, 2023
Manufacturer
Kareway Product, Inc.
Registration number
part348
NDC root
67510-0547

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Drug Overview

This medication is designed to provide temporary relief from minor aches and pains in your muscles and joints. It can be particularly helpful for conditions such as arthritis, simple backache, strains, bruises, and sprains. If you're experiencing discomfort from any of these issues, this drug may be a suitable option to help ease your pain.

Uses

If you're dealing with minor aches and pains in your muscles and joints, this medication can help provide temporary relief. It's effective for discomfort associated with various conditions, including arthritis, simple backaches, strains, bruises, and sprains.

You can rely on this treatment to ease your pain and help you get back to your daily activities. Remember, it's designed for short-term use to manage these specific types of discomfort.

Dosage and Administration

To use this medication effectively, start by cleaning and drying the area of your skin that is affected. Once the area is prepared, carefully remove the patch from its protective film. You can apply the patch to the affected area up to three to four times a day, but remember to take it off after a maximum of eight hours of use.

If you are applying 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. Always follow these guidelines to help manage the condition effectively.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not use it on wounds or damaged skin, with a heating pad, or if you are allergic to any of its ingredients. While using the product, make sure to avoid contact with your eyes, mucous membranes, or any rashes. Additionally, do not apply a tight bandage over the area where you use the product.

By following these guidelines, you can help ensure a safer experience and minimize the risk of adverse effects. If you have any concerns or questions about using this product, please consult with a healthcare professional.

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 you experience a rash, itching, or excessive skin irritation. Additionally, if your condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then return within a few days, seek medical advice.

If you have a history of allergic reactions to aspirin or salicylates, consult your doctor before use. This product is for external use only and should not be applied to wounds or damaged skin, nor should it be used with a heating pad. Always avoid contact with your eyes and mucous membranes, and do not bandage the area tightly. If you are pregnant or breastfeeding, it's best to consult a healthcare professional before using this product. Keep it out of reach of children, and if swallowed, seek medical help immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds or damaged skin. If you have a history of allergic reactions to aspirin or salicylates, consult your doctor before using this product. It's important to use it as directed and to keep it away from your eyes, mucous membranes, and any rashes. Avoid using it with a heating pad and do not bandage the area tightly.

If you experience a rash, itching, or excessive skin irritation, or if your condition worsens or does not improve after 7 days, stop using the product and contact your doctor. If you are pregnant or breastfeeding, please consult a healthcare professional before use. Always keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of this 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.

Signs of an overdose may include unusual symptoms, but specific details about these symptoms are not provided here. Always err on the side of caution and get help if you suspect an overdose has occurred. Your safety is the top priority, so don’t hesitate to reach out for assistance.

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 12 years old, it's important to consult a doctor before using this medication. For those aged 12 and older, you can apply it to the affected area up to 3 to 4 times a day, but remember to remove the patch after a maximum of 8 hours. Always keep this medication out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately. Your child's safety is the top priority, so following these guidelines is essential.

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 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 your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition 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 talk to your healthcare provider before using this medication, especially if you have a history of allergic reactions to aspirin or salicylates (a group of drugs that includes aspirin). Your doctor can help determine if this medication is safe for you.

Additionally, there are no specific interactions with other drugs or laboratory tests noted, but it's always a good practice to discuss all medications and tests you are undergoing with your healthcare provider. This ensures your safety and helps avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place away from direct sunlight. Exposure to sunlight can damage the product, while excessive moisture can compromise its integrity.

When handling the product, be mindful of these storage conditions to maintain its quality. Always check for any signs of damage before use, and if you have any concerns about its condition, consult the instructions or a professional for guidance.

Additional Information

You should apply this medication to the affected area of your skin using a topical (applied directly to the skin), percutaneous (absorbed through the skin), or transdermal (delivered through a patch) method. Use it no more than 3 to 4 times a day, and remember to remove the patch after a maximum of 8 hours.

If you are pregnant or breastfeeding, consult a healthcare professional before using this medication. Keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is the drug used for?

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

How should I use this drug?

For adults and children 12 years and older, clean and dry the affected area, remove the patch from the film, and apply it not more than 3 to 4 times daily. Remove the patch after a maximum of 8 hours.

What should I do if I am under 12 years old?

If you are under 12 years of age, you should consult a doctor before using this product.

Are there any warnings I should be aware of?

This product is for external use only. Avoid contact with eyes, mucous membranes, or rashes, and do not use on wounds or damaged skin.

What should I do if I experience a rash or irritation?

Stop using the product and ask a doctor if you develop a rash, itching, or excessive skin irritation, if conditions worsen, or if symptoms persist for more than 7 days.

Can I use this product if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using this product.

What should I do if I swallow this product?

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

Are there any specific conditions under which I should not use this product?

Do not use this product if you are allergic to any of its ingredients, if you are prone to allergic reactions from aspirin or salicylates, or if you are using a heating pad.

Packaging Info

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

Packaging configurations for Soundbody Medicated Patch.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is a transdermal patch designed to provide localized pain relief. Each patch contains 4% lidocaine as the active ingredient. The formulation includes several inactive ingredients, specifically acrylic adhesive, polyethylene, polypropylene, silicone, and other excipients as necessary for the formulation. The SPL Code for this product is 34089-3.

Uses and Indications

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

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

Dosage and Administration

Adults and children 12 years of age and over should begin by cleaning and drying the affected area thoroughly. The patch should then be removed from its protective film and applied directly to the affected area. It is recommended that the patch be applied no more than 3 to 4 times daily. Each patch should be removed from the skin after a maximum application duration of 8 hours.

For children under 12 years of age, it is advised to consult a healthcare professional prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

Application on wounds or damaged skin is prohibited due to the potential for irritation and adverse reactions. The use of a heating pad in conjunction with this product is also contraindicated, as it may lead to excessive heat and increase the risk of burns or skin damage.

Patients with known allergies to any ingredients in this product should not use it, as this may result in allergic reactions.

While using this product, it is essential to avoid contact with the eyes, mucous membranes, or rashes to prevent irritation. Additionally, tight bandaging is not recommended, as it may impede circulation and exacerbate skin issues.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of allergic reactions to aspirin or salicylates. This product is contraindicated for application on wounds or damaged skin and should not be used in conjunction with a heating pad.

Patients must be cautioned against using this product if they are allergic to any of its ingredients. While using this product, it is imperative to follow the directions provided, avoiding contact with the eyes, mucous membranes, or any rashes. Additionally, patients should refrain from tightly bandaging the area of application.

In the event of rash, itching, or excessive skin irritation, patients should discontinue use and seek medical advice. They should also be instructed to contact a healthcare professional if their condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days.

For pregnant or breastfeeding individuals, consultation with a healthcare professional is recommended prior to use. It is essential to keep this product out of reach of children. In case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients should be aware that this product is intended for external use only. Individuals with a known allergy to aspirin or salicylates are advised to consult a healthcare professional prior to use. The product should not be applied to wounds or damaged skin, nor should it be used in conjunction with a heating pad. Additionally, it is important to avoid contact with the eyes, mucous membranes, or rashes, and to refrain from tightly bandaging the area of application.

During the use of this product, patients are instructed to follow the directions carefully. They should discontinue use and seek medical advice if they experience a rash, itching, or excessive skin irritation. Furthermore, if the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, medical consultation is recommended.

Additional considerations include the need for pregnant or breastfeeding individuals to consult a healthcare professional before using this product. It is also crucial to keep the product out of reach of children; in the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Interactions

Patients with a known hypersensitivity to aspirin or salicylates should consult a healthcare professional prior to using this medication. This precaution is essential to avoid potential allergic reactions.

There are no specific drug or laboratory test interactions identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary. However, it is always advisable for patients to inform their healthcare provider of all medications and supplements they are taking to ensure comprehensive care.

Packaging & NDC

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

Packaging configurations for Soundbody Medicated Patch.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. For adolescents aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. The patch should be removed from the skin after a maximum application time of 8 hours.

It is important to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

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

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 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 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. 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 of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential.

Management procedures should include monitoring the patient for any adverse effects and providing supportive care as necessary. It is advisable to have the product label or any relevant information available when contacting medical professionals or poison control for guidance on further management steps.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 not to apply the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad.

Patients should be informed that they must not use the product if they have a known allergy to any of its ingredients. They should be counseled to discontinue use and consult a doctor if they experience rash, itching, or excessive skin irritation. Additionally, patients should be advised to stop using the product 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.

When using the product, patients should be reminded to follow the directions carefully and to avoid contact with the eyes, mucous membranes, or rashes. They should also be cautioned against tightly bandaging the area where the product is applied. For patients with a history of allergic reactions to aspirin or salicylates, it is essential to recommend consulting a doctor prior to use.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dry place, away from direct sunlight to maintain its integrity. Additionally, the product must be protected from excessive moisture to ensure optimal quality and efficacy. Proper handling and storage conditions are crucial for preserving the product's effectiveness.

Additional Clinical Information

The route of administration for the medication is topical, percutaneous, and transdermal. Patients are advised to apply the treatment to the affected area no more than 3 to 4 times daily and to remove the patch from the skin after a maximum of 8 hours of application.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is important to keep the medication out of reach of children, and in the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Soundbody Medicated Patch, 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 Soundbody Medicated Patch, 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.