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Dynarex Muscle Rub Cream

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This product has been discontinued

Active ingredients
  • Menthol 10 mg/1 g
  • Methyl Salicylate 15 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 2016
Label revision date
June 15, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 10 mg/1 g
  • Methyl Salicylate 15 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 2016
Label revision date
June 15, 2017
Manufacturer
Dynarex Corporation
Registration number
part348
NDC root
67777-416
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

Dynarex Cream is a topical product designed to provide temporary relief from minor aches and pains associated with sore muscles and joints. It can be a helpful option if you're looking for a way to soothe discomfort in these areas.

Uses

You can use this medication for the temporary relief of minor aches and pains in sore muscles and joints. Whether you've been active or just experiencing discomfort, this product can help ease your symptoms 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, making it a safer option for those concerned about such risks.

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 areas of your skin up to three or four times a day.

For children under 12 years of age, it's best to consult a physician (doctor) before use to ensure safety and proper guidance. Always follow the instructions provided to achieve the best results.

What to Avoid

If you are using this medication, it's important to know when to stop and consult your doctor. You should stop using it and seek medical advice if your condition worsens, if symptoms last longer than 7 days, if your symptoms improve and then return after a few days, or if you notice redness or excessive skin irritation.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. However, always prioritize your health and safety by following these guidelines.

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 your condition worsens, if symptoms last longer than 7 days, or if they improve and then return after a few days. Additionally, if you notice redness or excessive skin irritation, seek medical advice.

Remember, this product is for external use only. Avoid contact with your eyes or mucous membranes, and do not apply it to wounds or damaged skin. It's also best not to bandage the area tightly or use it with a heating pad or device.

Warnings and Precautions

This product is for external use only, so please avoid getting it in your eyes or on mucous membranes. Do not apply it to any wounds or damaged skin, and avoid tightly bandaging the area where you apply it. Additionally, do not use it with a heating pad or any heating device.

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

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 extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's 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 planning to become pregnant, it's reassuring to know that there are no specific warnings, precautions, or contraindications related to the use of Dynarex Muscle Rub Cream mentioned in the drug insert. This means that, based on the available information, the cream does not pose known risks during pregnancy.

However, it's always a good idea to consult with your healthcare provider before using any new products while pregnant, just to ensure they are safe for you and your baby. Your health and the health of your baby are the top priority, so staying informed and cautious is key.

Lactation Use

If you are breastfeeding, you can use Dynarex Muscle Rub Cream without specific warnings or recommendations against it. Currently, there is no information available about whether the ingredients in this cream pass into breast milk or if they pose any risk to your nursing infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns about using new products while breastfeeding.

Pediatric Use

If your child is under 12 years old, it's important to consult a physician (doctor) before using this medication. For children aged 12 and older, you can apply the medication to the affected areas, but be sure not to exceed 3 or 4 applications in a day. Always follow these guidelines to ensure your child's safety and well-being.

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, it’s important to consult with a healthcare provider before starting the medication. 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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° and 25°C (68° and 77°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a sterile field (a clean area free from germs) to prevent contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

You should apply this medication topically to the affected areas, using it no more than 3 or 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.

FAQ

What is Dynarex Cream used for?

Dynarex Cream is used for the temporary relief of minor aches and pains of sore muscles and joints.

How should I use Dynarex Cream?

You should apply Dynarex Cream to the affected areas not more than 3 or 4 times daily if you are an adult or a child 12 years of age and older. Children under 12 years should consult a physician.

Are there any warnings for using Dynarex Cream?

Yes, Dynarex Cream is for external use only. Avoid contact with eyes or mucous membranes, do not apply to wounds or damaged skin, and do not use with a heating pad.

What should I do if my condition worsens while using Dynarex Cream?

You should stop using Dynarex Cream and ask a doctor if your condition worsens, if symptoms persist for more than 7 days, or if redness or excessive skin irritation develops.

Is Dynarex Cream safe to use during pregnancy or while nursing?

There are no specific warnings or contraindications regarding the use of Dynarex Cream during pregnancy or for nursing mothers.

What should I do if Dynarex Cream is accidentally ingested?

If Dynarex Cream is accidentally ingested, seek medical help or contact a Poison Control Center immediately.

How should I store Dynarex Cream?

Store Dynarex Cream at a temperature between 20° - 25°C (68°-77°F).

Packaging Info

Below are the non-prescription pack sizes of Dynarex Muscle Rub Cream (menthol and methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dynarex Muscle Rub Cream.
Details

Drug Information (PDF)

This file contains official product information for Dynarex Muscle Rub Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Dynarex Cream is a topical formulation designed for dermatological use. It is presented in a cream dosage form, facilitating easy application to the skin. The product is characterized by its specific formulation, which includes a blend of active and inactive ingredients tailored for effective skin care. The cream exhibits a smooth texture and is typically packaged in a convenient container for user accessibility.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints.

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 areas no more than 3 to 4 times daily. For children under 12 years of age, consultation with a physician is advised prior to use.

Contraindications

There are no specified contraindications for this product. However, it is advised to discontinue use and consult a healthcare professional if the following conditions occur: worsening of the condition, persistence of symptoms beyond 7 days, recurrence of symptoms after initial improvement, or the presence of redness or excessive skin irritation.

Warnings and Precautions

For external use only, this product must be applied with caution to prevent adverse effects. It is imperative to avoid contact with the eyes or mucous membranes, as such contact may lead to irritation or injury. The product should not be applied to wounds or damaged skin, as this could exacerbate the condition or lead to further complications. Additionally, it is essential to avoid tight bandaging of the area where the product is applied, as this may impede circulation and increase the risk of skin irritation. The use of heating pads or devices in conjunction with this product is contraindicated, as it may lead to increased absorption and potential toxicity.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens or symptoms persist beyond 7 days; symptoms resolve only to reappear within a few days; or if there is the presence of redness or excessive skin irritation. Monitoring for these signs is crucial to ensure patient safety and effective management of the condition being treated.

Side Effects

Patients using this product should be aware of several important warnings and recommendations regarding its use. This product is intended for external use only and should not come into contact with the eyes or mucous membranes. It is contraindicated for application on wounds or damaged skin, and users are advised against tightly bandaging the area of application. Additionally, the use of heating pads or devices in conjunction with this product is not recommended.

Patients are instructed to stop using the product and consult a doctor if any of the following occur: the condition worsens or symptoms persist for more than 7 days; symptoms resolve and then recur within a few days; or if there is the presence of redness or excessive skin irritation. These precautions are essential to ensure the safety and well-being of patients during treatment.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources for any emerging data regarding potential interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Dynarex Muscle Rub Cream (menthol and methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dynarex Muscle Rub Cream.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. For adolescents and children aged 12 years and older, the recommended application is to the affected areas not more than 3 or 4 times daily.

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

There are no specific warnings, precautions, or contraindications regarding pregnancy associated with the use of Dynarex Muscle Rub Cream. Available data do not indicate any known risks to pregnant patients or potential adverse fetal outcomes. However, as with any medication, healthcare professionals should consider the benefits and risks when recommending this product to women of childbearing potential. It is advisable for pregnant patients to consult their healthcare provider before using this product to ensure it aligns with their individual health needs and circumstances.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions 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.

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 patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, alterations in vital signs, neurological changes, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Supportive care is the cornerstone of management, which may include the following steps:

  1. Assessment: Conduct a thorough evaluation of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide symptomatic treatment as necessary, which may involve intravenous fluids, oxygen supplementation, or other interventions based on the patient's condition.

  3. Consultation: Engage with a poison control center or toxicology specialist for guidance on specific management strategies tailored to the substance involved.

Healthcare professionals should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

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 provided in the insert for DYNAREX MUSCLE RUB CREAM.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important for patients to understand the potential risks associated with accidental ingestion. In the event that the medication is ingested, patients should be instructed to seek medical help or contact a Poison Control Center immediately for guidance. This information is crucial for ensuring the safety and well-being of both patients and their families.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 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 regarding appropriate use. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Dynarex Muscle Rub 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 Dynarex Muscle Rub 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.