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Debbies Down and Dirty Deep Tissue Joint and Muscle

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Active ingredient
Menthol 100 mg/1 mL
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 2017
Label revision date
November 11, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 100 mg/1 mL
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 2017
Label revision date
November 11, 2023
Manufacturer
DD&D Manufacturing Co. , Ltd
Registration number
M017
NDC root
71523-833
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 can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It is commonly used for conditions such as simple backache, arthritis, sprains, strains, and bruises. This means that if you're experiencing discomfort from these issues, this drug may help alleviate your pain and improve your comfort.

Uses

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It is effective for conditions such as simple back pain, arthritis, sprains, strains, and bruises. If you're experiencing discomfort from any of these issues, this medication may help alleviate your symptoms.

Dosage and Administration

When using this medication, it's important to follow the directions provided. For adults and children aged 12 years and older, you should apply a generous amount to the area that is causing you pain. After applying, gently massage the medication into your skin until it is fully absorbed.

If you are considering using this medication for a child under 12 years old, it's essential to consult a physician (a medical doctor) first to ensure it's safe and appropriate for them. Always remember to use the medication only as directed for the best results.

What to Avoid

It's important to use this medication safely to ensure your well-being. You should never apply it to wounds or damaged skin, as this can lead to complications. Additionally, avoid contact with your eyes, as this could cause irritation or other issues. Lastly, do not bandage the area where you apply the medication, as this may affect its effectiveness or lead to unwanted side effects. Always follow these guidelines to use the medication properly.

Side Effects

When using this product, it's important to apply it only to the skin and avoid any contact with your eyes. Do not use it on wounds or damaged skin, and refrain from bandaging the area after application. If you notice any redness over the affected area, consult your physician before continuing use.

You should stop using the product and seek medical advice if your condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then return within a few days. Additionally, if you experience excessive skin irritation, it's best to discontinue use. In the event of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please do not apply it to wounds or damaged skin. If you notice any redness in the area you plan to treat, it's a good idea to consult your doctor before using it. While using this product, be careful to avoid contact with your eyes, and do not cover the area with a bandage.

You should stop using the product and contact 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 experience excessive skin irritation. Always keep this product out of reach of children. If it is accidentally ingested, seek medical help or contact a Poison Control Center immediately.

Overdose

If you accidentally take too much of a medication, it's important to seek medical help immediately. You can do this by contacting a healthcare professional or calling a Poison Control Center. They are equipped to provide guidance and support in these situations.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice any concerning changes in your health after taking a medication, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in your safety and well-being.

Pregnancy Use

When it comes to using this medication during pregnancy, there is currently no information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it is essential to consult with your healthcare provider before using this medication. They can help you understand any potential risks and make informed decisions about your treatment options. Always prioritize your health and the health of your baby by seeking professional guidance.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your doctor before using this product. There is a possibility that it could be passed into your breast milk, and the effects on your nursing infant are not fully understood. Taking this precaution can help ensure the safety and well-being of both you and your baby.

Pediatric Use

If your child is under 12 years old, it's important to consult a physician (doctor) before using this medication. For those aged 12 and older, you can apply the medication generously to the affected area. Be sure to massage it into the skin until it is fully absorbed. Always follow your healthcare provider's advice to ensure safe and effective use.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication with your doctor 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 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 great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep the container tightly closed. It's important to protect the product from light to maintain its effectiveness. Once you open the container, be sure to discard any remaining product, as it should not be reused. Following these guidelines will help you use the product safely and effectively.

Additional Information

The medication is administered topically, meaning it is applied directly to the skin. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any specific questions or concerns about using this medication, it's best to consult your healthcare provider for personalized advice.

FAQ

What is this drug used for?

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

Who can use this drug?

Adults and children 12 years of age and older can use this drug. Children under 12 years of age should consult a physician.

How should I apply this drug?

You should apply it generously to the affected area and massage it into the skin until thoroughly absorbed.

Are there any warnings for using this drug?

Yes, it is for external use only. Do not apply to wounds or damaged skin, and avoid contact with the eyes.

What should I do if my condition worsens?

Stop use and ask a physician if your condition worsens or if symptoms persist for more than 7 days.

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 nursing mothers use this drug?

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

How should I store this drug?

Store at room temperature, keep the container tightly closed, and protect it from light. Discard after opening.

Packaging Info

Below are the non-prescription pack sizes of Debbies Down and Dirty Deep Tissue Joint and Muscle (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Debbies Down and Dirty Deep Tissue Joint and Muscle.
Details

Drug Information (PDF)

This file contains official product information for Debbies Down and Dirty Deep Tissue Joint and Muscle, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

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

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 a generous amount to the affected area. The application should be followed by a gentle massage into the painful area until the product is thoroughly absorbed into the skin.

For children under 12 years of age, it is advised to consult a physician prior to use to ensure safety and appropriateness of treatment.

Contraindications

The product should not be applied to wounds or damaged skin due to the potential for irritation or adverse reactions. Contact with the eyes must be avoided to prevent ocular harm. Additionally, the product should not be bandaged, as this may alter its intended use and effectiveness.

Warnings and Precautions

This product is intended for external use only and should not be applied to wounds or damaged skin. Healthcare professionals are advised to instruct patients to consult a physician prior to use if there is any redness present over the affected area.

During the application of this product, it is crucial to avoid contact with the eyes. Additionally, patients should be cautioned against bandaging the area where the product is applied.

Patients must be advised to discontinue use and seek medical advice 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 excessive skin irritation develops.

It is imperative to keep this product 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 without delay.

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. It is important to avoid contact with the eyes during application and to refrain from bandaging the treated area.

Participants are advised to consult a physician prior to use if there is any redness over the affected area. If the condition worsens or symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use and seek medical advice. Additionally, if excessive skin irritation occurs, it is recommended to stop use and consult a physician.

In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Debbies Down and Dirty Deep Tissue Joint and Muscle (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Debbies Down and Dirty Deep Tissue Joint and Muscle.
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 involves generously applying the product to the affected area and massaging it into the skin until thoroughly absorbed.

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

There is no information available regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled accordingly, and alternative treatments may be considered in the absence of established safety profiles.

Lactation

Lactating mothers should consult a physician before using this product. There is a potential for excretion in breast milk, and the effects on the nursing infant are not known.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 accidental ingestion, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of overdosage should be guided by clinical judgment and may involve supportive care and symptomatic treatment as necessary.

It is essential to monitor the patient closely and provide appropriate interventions based on the clinical presentation. Documentation of the incident and any actions taken should be maintained for further evaluation and follow-up care.

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 compound in these areas.

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 in the event of accidental ingestion of the product. It is important to instruct patients not to apply the product to wounds or damaged skin to prevent further complications.

Patients should be informed to discontinue use and consult a physician 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 excessive skin irritation develops.

While using the product, patients should be cautioned to avoid contact with the eyes and to refrain from bandaging the area where the product is applied. Additionally, healthcare providers should encourage patients to consult a physician prior to use if there is any redness present over the affected area.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the product is topical. 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 Debbies Down and Dirty Deep Tissue Joint and Muscle, 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 Debbies Down and Dirty Deep Tissue Joint and Muscle, 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.