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Sound Body Extra Strength Cold and Hot

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This product has been discontinued

Active ingredients
  • Menthol 10 g/100 g
  • Methyl Salicylate 30 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 2015
Label revision date
February 24, 2015
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 10 g/100 g
  • Methyl Salicylate 30 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 2015
Label revision date
February 24, 2015
Manufacturer
United Exchange Corp.
Registration number
part348
NDC root
65923-616
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

You may be looking for a topical medication designed for adults and children over 12 years old to relieve pain. This product is applied directly to the affected area of the skin, where you should massage it in until it is fully absorbed. You can use it as needed, but no more than four times a day.

For children under 12 years old, it's important to consult a doctor before use. Always remember to close the cap tightly after applying the medication and keep the carton, as it contains important information.

Uses

You can use this product to help relieve pain in specific areas of your body. To apply, make sure to use a generous amount and massage it into the affected area until it is fully absorbed by your skin. You can repeat this process as needed, but try not to apply it more than four times a day.

If you are considering using this product for a child who is 12 years old or younger, it’s best to consult with a doctor first to ensure it’s safe for them.

Dosage and Administration

It seems that there is no specific dosage or administration information available for the medication you are inquiring about. This means that details such as how much to take, how often to take it, or how to apply it are not provided.

If you have any questions about how to use this medication or need guidance on its administration, it's best to consult with your healthcare provider or pharmacist. They can give you the most accurate and personalized information based on your health needs.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not bandage tightly or use it with a heating pad, as this can lead to complications. Additionally, avoid applying it to wounds, damaged, broken, or irritated skin, and make sure to keep it away from your eyes and mucous membranes to prevent irritation.

By following these guidelines, you can help ensure a safe and effective experience with the product. If you have any questions or concerns, don't hesitate to reach out for more information.

Side Effects

If you are using this product, please remember that it is for external use only. If you have a history of allergic reactions to aspirin or salicylates, it’s important to consult your doctor before using it.

You should stop using the product and contact your doctor if your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days. Additionally, if you notice any redness or develop irritation, seek medical advice.

Warnings and Precautions

This product is for external use only. If you have a history of allergic reactions to aspirin or salicylates, please consult your doctor before using it.

If you accidentally ingest this product, seek medical help or contact a Poison Control Center immediately. You should stop using the product and call your doctor if your condition worsens, if symptoms last longer than 7 days, if they improve and then return within a few days, if you notice any redness, or if irritation develops.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

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 you are considering using this medication for a child who is 12 years old or younger, it’s important to consult with a doctor first. This ensures that the treatment is safe and appropriate for your child's specific needs. Always prioritize your child's health by seeking professional advice before administering 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 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 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 change based on renal impairment. However, it’s always best to consult with your healthcare provider about your kidney health and any medications you are taking. They can provide personalized advice and ensure that your treatment is safe and effective for you.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver condition. They can help monitor your liver function and make any necessary adjustments to your treatment plan.

Drug Interactions

If you have a history of allergic reactions to aspirin or salicylates, it's important to talk to your doctor before using this medication. Allergies can lead to serious health issues, and your healthcare provider can help determine the best course of action 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 with your healthcare provider. This ensures your safety and helps manage your overall health effectively.

Storage and Handling

To ensure the best use of your product, always close the cap tightly after each use. This helps maintain its effectiveness and prevents contamination. Additionally, keep the carton, as it contains important information that you may need later.

By following these simple steps, you can safely store and handle the product, ensuring it remains in optimal condition for your needs.

Additional Information

You should apply this medication topically to the affected area, gently massaging it into the skin until it is fully absorbed. For adults and children over 12 years, you can repeat this process as needed, but do not exceed four applications in a day. If the user is a child under 12 years, consult a doctor before use.

If you are pregnant or breastfeeding, it's important to speak with a healthcare professional before using this product. Always keep it out of reach of children, and if it is accidentally ingested, seek medical help or contact a Poison Control Center immediately.

FAQ

Who can use this medication?

This medication is for adults and children over 12 years. For children 12 years or younger, you should ask a doctor.

How should I apply this medication?

Apply generously to the affected area and massage it into the skin until thoroughly absorbed. You can repeat this process as necessary, but no more than 4 times daily.

What should I do if my condition worsens?

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

Are there any specific warnings for this medication?

Yes, this medication is for external use only. If you are prone to allergic reactions from aspirin or salicylates, consult a doctor before use.

What should I avoid while using this medication?

Do not bandage tightly, use with a heating pad, or apply to wounds, damaged, broken, or irritated skin. Avoid contact with eyes or mucous membranes.

What should I do in case of accidental ingestion?

Get medical help or contact a Poison Control Center right away if accidental ingestion occurs.

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

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

How should I store this medication?

Close the cap tightly after use and keep the carton, as it contains important information.

Packaging Info

Below are the non-prescription pack sizes of Sound Body Extra Strength Cold and Hot (menthol, and methyl salcylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sound Body Extra Strength Cold and Hot.
Details

Drug Information (PDF)

This file contains official product information for Sound Body Extra Strength Cold and Hot, 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 additional specific description details are provided in the available text.

Uses and Indications

This drug is indicated for the topical treatment of localized pain. It should be applied generously to the affected area and massaged into the skin until thoroughly absorbed. The application may be repeated as necessary, but should not exceed four times daily.

For pediatric patients aged 12 years or younger, it is advised to consult a healthcare professional prior to use. There are no specific teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

No dosage and administration information is available for this product. Healthcare professionals are advised to consult the prescribing information or relevant clinical guidelines for specific dosing recommendations and administration techniques.

Contraindications

The product should not be used in the following situations:

Tight bandaging or the use of a heating pad in conjunction with the product is contraindicated, as this may lead to adverse effects. Application to wounds, damaged, broken, or irritated skin is also contraindicated due to the potential for exacerbating the condition. Additionally, contact with eyes or mucous membranes must be avoided to prevent irritation or injury.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to exercise caution, particularly those with a known allergy to aspirin or salicylates. Such individuals are encouraged to consult a physician prior to use to mitigate the risk of an allergic reaction.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately. This precaution is critical to ensure patient safety and appropriate management of potential toxicity.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, redness appears, or irritation develops. These actions are essential to prevent further complications and to ensure effective treatment.

Side Effects

Patients using this product should be aware that it is intended for external use only. There is an allergy alert for individuals who are prone to allergic reactions from aspirin or salicylates; such patients should consult a doctor prior to use.

In clinical practice, patients are advised to stop using the product and seek medical attention if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, the presence of redness or the development of irritation should prompt patients to discontinue use and consult a healthcare professional.

Drug Interactions

Patients with a known allergy to aspirin or salicylates should consult a healthcare professional prior to use, as there is a potential risk of allergic reactions.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Sound Body Extra Strength Cold and Hot (menthol, and methyl salcylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sound Body Extra Strength Cold and Hot.
Details

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional prior to use. This precaution is essential to ensure safety and appropriateness of treatment in this age group.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

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

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 and consider the overall clinical context when prescribing this medication to patients with hepatic impairment, as individual responses may vary.

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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist is recommended for guidance on the management of overdose cases.

Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, is crucial for effective management and treatment planning.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to keep this product out of reach of children. In the event of accidental ingestion, they should seek medical help or contact a Poison Control Center immediately.

Healthcare providers should instruct patients to discontinue use and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than 7 days or resolve and then recur within a few days, redness appears, or irritation develops.

When using this product, patients must be reminded to use it only as directed. They should not bandage the area tightly or use it in conjunction with a heating pad. It is important to avoid contact with the eyes or mucous membranes and to refrain from applying the product to wounds, damaged, broken, or irritated skin.

Storage and Handling

The product is supplied in a carton that contains important information for the user. It is essential to keep the carton for reference. After each use, the cap should be closed tightly to ensure the integrity of the product. Proper handling and storage are crucial to maintain the product's quality and effectiveness.

Additional Clinical Information

The product is administered topically, with specific instructions for different age groups. Adults and children over 12 years should apply the product generously to the affected area, massaging it into the skin until fully absorbed, with a maximum frequency of four times daily. For children aged 12 years or younger, it is advised to consult a doctor before use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the product out of reach of children, and in the event of accidental ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

This file contains official product information for Sound Body Extra Strength Cold and Hot, 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 Sound Body Extra Strength Cold and Hot, 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.