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Dynarub

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Active ingredients
  • Menthol 10 g/100 g
  • Methyl Salicylate 15 g/100 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
November 20, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 10 g/100 g
  • Methyl Salicylate 15 g/100 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
November 20, 2024
Manufacturer
Dynarex Corporation
Registration number
M017
NDC root
67777-113
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

1135 DynRub is a topical medication designed to provide temporary relief from minor aches and pains in muscles and joints. It is commonly used for discomfort associated with conditions such as simple backache, arthritis, strains, bruises, and sprains. This product can be a helpful option if you're looking for a way to soothe these everyday aches.

Uses

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. This includes discomfort related to simple backaches, arthritis, strains, bruises, and sprains. It’s designed to help you feel more comfortable and get back to your daily activities.

Rest assured, there are no known 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

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

For children under 2 years of age, it’s important to consult a doctor before using this medication. This will help ensure safety and proper care for younger children. Always follow your healthcare provider's advice regarding dosage and application.

What to Avoid

It's important to be aware of certain precautions when using this product. You should not apply it to wounds or damaged skin, as this could lead to complications or hinder healing.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this product. Always follow the usage instructions carefully to ensure your safety and well-being.

Side Effects

When using this product, it's important to remember that it is for external use only and should not be applied to wounds or damaged skin. Be careful to avoid contact with your eyes, and do not wrap the area tightly with a bandage.

If your condition worsens, or if symptoms persist for more than 7 days or return after clearing up, you should stop using the product and consult a doctor. Additionally, if the product is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds or damaged skin. While using it, be careful not to let it come into contact with your eyes, and do not wrap the area tightly with a bandage.

If your condition worsens, or if your symptoms last more than 7 days or improve and then return within a few days, stop using the product and consult your doctor. In case of accidental swallowing, seek emergency 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 can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t wait—get help right away. Remember, acting quickly can make a significant difference in the outcome.

Pregnancy Use

The safety of this product during pregnancy has not been established, which means that it may not be safe for you or your developing baby. It is not recommended to use this product while pregnant due to potential risks to the fetus. If you are pregnant or planning to become pregnant, it is important to consult your healthcare provider before using this product to discuss any possible risks and alternatives. Your health and the health of your baby are the top priority, so always seek professional advice when considering medication during this time.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant associated with its use during lactation. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, you should consult a doctor before using the medication. This ensures their safety and proper care. Always follow these recommendations to help your child effectively and safely.

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 for personalized advice. 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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

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

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal.

Additional Information

For adults and children aged 2 years and older, you should apply the medication to the affected area no more than 3 to 4 times a day. If the patient is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is 1135 DynRub used for?

1135 DynRub is used for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

How should I apply 1135 DynRub?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily. For children under 2 years of age, consult a doctor.

Are there any warnings for using 1135 DynRub?

Yes, it is for external use only, and you should not use it on wounds or damaged skin. Avoid contact with eyes and do not bandage tightly.

What should I do if my condition worsens while using 1135 DynRub?

Stop use and ask a doctor if your condition worsens or if symptoms last more than 7 days or clear up and occur again within a few days.

What should I do if I accidentally swallow 1135 DynRub?

If swallowed, get medical help or contact a Poison Control Center right away.

Is 1135 DynRub safe to use during pregnancy?

The safety of 1135 DynRub during pregnancy has not been established, and its use is not recommended due to potential risks to the fetus. Consult a healthcare provider if pregnant or planning to become pregnant.

Can nursing mothers use 1135 DynRub?

There are no specific warnings or recommendations regarding the use of this product by nursing mothers.

What is the recommended storage condition for 1135 DynRub?

Store 1135 DynRub at 20°-25°C (68°-77°F).

Packaging Info

Below are the non-prescription pack sizes of Dynarub (pain relieving cream). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dynarub.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

SPL code 34089-3 corresponds to the product known as 1135 DynRub. This formulation is characterized by its specific composition and intended use within the medical field. Further details regarding its molecular weight, chemical formula, and dosage form are not provided in the extracted facts.

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a healthcare professional prior to use to determine the appropriate course of action.

Contraindications

The use of this product is contraindicated on wounds or damaged skin due to the potential for irritation and impaired healing. No other contraindications have been specified.

Warnings and Precautions

This product is intended for external use only and should not be applied to wounds or damaged skin. Healthcare professionals should advise patients to avoid contact with the eyes during application. Additionally, it is important to instruct patients not to bandage the area tightly, as this may lead to complications.

Patients should be informed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. These actions are crucial for ensuring patient safety and effective management of their condition.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay. Prompt action in such cases is essential to mitigate potential health risks.

Side Effects

Patients using this product should be aware that it is intended for external use only and should not be applied to wounds or damaged skin. During use, it is important to avoid contact with the eyes and to refrain from tightly bandaging the area.

In the event that the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, patients are advised to stop use and consult a healthcare professional.

Additionally, if the product is ingested, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Dynarub (pain relieving cream). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dynarub.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

Geriatric Use

There is no specific information available 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, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. Use is not recommended during pregnancy due to potential risks to the fetus. Pregnant patients or women of childbearing potential should consult a healthcare provider before use if they are pregnant or planning to become pregnant.

Lactation

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

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the insert text. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted in these patients to ensure safety and therapeutic effectiveness.

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 or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that the product should not be applied to wounds or damaged skin to prevent further complications.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their condition worsens. Additionally, patients should be made aware that if symptoms persist for more than 7 days or if symptoms resolve and then recur within a few days, they should stop using the product and seek medical advice.

While using the product, patients must be cautioned to avoid contact with their eyes to prevent irritation or injury. Furthermore, it is essential to advise patients against tightly bandaging the area where the product is applied, as this may lead to adverse effects.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

For patients aged 2 years and older, the medication should be applied to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Dynarub, 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 Dynarub, 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.