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Imbue

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This product has been discontinued

Active ingredients
  • Menthol 51 mg
  • Methyl Salicylate 15 mg
Other brand names
Dosage form
Patch
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
February 1, 2011
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 51 mg
  • Methyl Salicylate 15 mg
Other brand names
Dosage form
Patch
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 2011
Label revision date
February 1, 2011
Manufacturer
Imbue Body LLC
Registration number
part356
NDC root
75979-1146
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

This medication is designed to temporarily relieve minor aches and pains in your muscles and joints. It can be helpful for various conditions, including simple backaches, muscle strains, sprains, arthritis, bruises, bursitis (inflammation of the bursa), and tendinitis (inflammation of a tendon).

By targeting these discomforts, this drug aims to provide you with relief so you can feel more comfortable in your daily activities.

Uses

You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. It is effective for conditions such as simple backache, muscle strains, sprains, arthritis, bruises, bursitis, and tendinitis. If you're experiencing discomfort from any of these issues, this medication may help ease your pain and improve your mobility.

Dosage and Administration

To use the patch effectively, start by carefully peeling off the clear film, making sure not to let the sticky side touch itself. Place the sticky side of the patch directly on your skin, covering as much of the painful area as possible. You can leave the patch on for up to 8 hours, but keep in mind that it may take some time for the pain relief to kick in.

For adults and children over 12 years, you can use 1 to 2 patches each day. Just remember to wait 12 to 24 hours before applying any additional patches to prevent skin irritation. After applying the patch, wash your hands thoroughly. If you find the patch difficult to remove, soaking it in warm water or vegetable oil can help; just peel it off slowly afterward. If you need to treat a smaller area, you can cut the patch to size before removing the protective film. For children under 12 years, it’s important to consult a doctor before use.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not get it in your eyes or on mucous membranes, as this can cause irritation. Additionally, avoid applying it to wounds, damaged, or irritated skin, as this may lead to further complications.

When using this product, do not bandage the area tightly or use it in conjunction with a heating pad, as this can increase the risk of adverse effects. Always follow these guidelines to ensure your safety and well-being.

Side Effects

This product is intended for external use only. While using it, you should be aware of some important signs that may indicate a need to stop using the product and consult a doctor. If your condition worsens, you experience severe skin irritation, or if pain lasts longer than 7 days, it’s important to seek medical advice.

Warnings and Precautions

This product is for external use only, so please avoid ingesting it. Keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

You should stop using this product and consult your doctor if your condition worsens, if you experience severe skin irritation, or if pain lasts longer than 7 days. It's important to pay attention to how your body responds and take action if needed.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are concerned about a possible overdose, seek medical help right away.

In case of an overdose, contacting your local poison control center or going to the nearest emergency room is crucial. They can provide the necessary guidance and treatment. Always remember that it's better to be safe and get checked if you have any doubts about your health.

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 professional 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 healthcare provider 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 guidance before administering any medication.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Remember, even if there are no specific dosage adjustments or safety concerns mentioned, your healthcare provider can offer personalized advice based on individual health status and any other medications being taken. Always prioritize open communication with your healthcare team to ensure the best care.

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 share your complete list of medications and any lab tests you undergo, as this helps in managing your health effectively.

Storage and Handling

To ensure the best performance of your product, store it in a cool area, away from direct sunlight. This helps maintain its effectiveness and safety. If you have any unused patches, be sure to re-seal the pouch tightly after each use to protect them from moisture and contamination. Following these simple steps will help you use the product safely and effectively.

Additional Information

You should apply 1 to 2 patches of this medication to your skin each day. It's important to wait 12 to 24 hours before applying any additional patches to prevent skin irritation. If you are pregnant or breastfeeding, consult with a healthcare professional before using this product. Be aware that some individuals may experience a skin rash as a side effect.

FAQ

What is the primary use of this drug?

This drug temporarily relieves minor aches and pains of muscles and joints associated with conditions like simple backache, muscle strain, sprains, arthritis, bruises, bursitis, and tendinitis.

How should I apply the patch?

Peel the clear film off the patch carefully and place the sticky surface on the skin, covering as much of the painful area as possible. Leave it in place for up to 8 hours.

Can I use more than one patch at a time?

You can use 1 to 2 patches per day, but wait 12 to 24 hours before applying additional patches to avoid skin irritation.

What should I do if the patch is difficult to remove?

If the patch is hard to remove, soak it in warm water or vegetable oil, then peel it off slowly.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Avoid getting it into your eyes or on mucus membranes, and do not apply it to wounds or damaged skin.

What should I do if my condition worsens or if I experience severe skin irritation?

Stop using the product and ask a doctor if your condition worsens, severe skin irritation develops, or if pain persists for more than 7 days.

Is this drug safe for children?

Children 12 years or younger should ask a doctor before use.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a healthcare professional before using this product.

How should I store the patches?

Store the patches in a cool area away from direct sunlight and always re-seal the pouch containing unused patches.

Packaging Info

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

Packaging configurations for Imbue.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No specific description details are available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various musculoskeletal conditions. Specifically, it is effective for alleviating discomfort related to simple backache, muscle strain, sprains, arthritis, bruises, bursitis, and tendinitis.

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

Dosage and Administration

Adults and children over 12 years of age should carefully peel the clear film off the patch, ensuring that the sticky surface does not adhere to itself. The sticky surface of the patch should be placed on the skin, covering as much of the painful area as possible. The patch may remain in place for up to 8 hours; however, it is important to note that pain relief may be delayed.

Patients may use 1 to 2 patches per day, with a recommended interval of 12 to 24 hours before applying additional patches to minimize the risk of skin irritation. After applying the patch, hands should be washed thoroughly to prevent accidental contact with other areas of the body.

In cases where the patch is difficult to remove, it is advisable to soak the area in warm water or vegetable oil before peeling it off slowly. The patch can also be cut to size prior to removing the protective film to accommodate smaller treatment areas.

For children 12 years of age or younger, it is essential to consult a physician before use.

Contraindications

Use is contraindicated in the following situations:

  • Application to the eyes or mucous membranes is prohibited due to the potential for irritation and adverse effects.

  • The product should not be applied to wounds, damaged, or irritated skin to prevent exacerbation of the condition or delayed healing.

  • Tight bandaging or use in conjunction with a heating pad is contraindicated to avoid increased risk of skin irritation or burns.

Warnings and Precautions

FOR EXTERNAL USE ONLY. This product is intended solely for topical application and should not be ingested.

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 a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, severe skin irritation develops, or if pain persists for more than 7 days. These symptoms may indicate a need for reevaluation of the treatment plan.

In cases of ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately to ensure appropriate management and care.

Side Effects

Patients should be advised that the product is for external use only.

In clinical practice, it is important to monitor for adverse reactions. Patients are instructed to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, development of severe skin irritation, or if pain persists for more than 7 days. These reactions warrant immediate medical attention to ensure patient safety and appropriate management.

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 as new data may emerge.

Packaging & NDC

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

Packaging configurations for Imbue.
Details

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional prior to use. This recommendation 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 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 healthcare professional prior to using this medication. There is currently no available data regarding 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 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 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 based on clinical judgment.

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.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management 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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified the occurrence of skin rash in some individuals following the use of this product. This event has been reported voluntarily and through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a physician if their condition worsens, if severe skin irritation occurs, or if pain persists for more than 7 days.

When using this product, it is essential for patients to follow the directions provided. They should be cautioned against allowing the product to come into contact with the eyes or mucous membranes. Additionally, patients should not apply the product to wounds, damaged, or irritated skin. It is important to inform patients not to bandage the area tightly or use the product in conjunction with a heating pad.

Storage and Handling

The product is supplied in pouches containing patches. It is essential to store the patches in a cool area, ensuring they are kept away from direct sunlight to maintain their integrity. After use, any unused patches should be re-sealed in their original pouch to prevent exposure to environmental factors that may compromise their effectiveness.

Additional Clinical Information

The product is administered topically, with a recommended usage of 1 to 2 patches per day. Clinicians should advise patients to wait 12 to 24 hours before applying additional patches to minimize the risk of skin irritation.

Patients who are pregnant or breastfeeding should consult a healthcare professional prior to use. It is important to inform patients that the product may cause skin rash in some individuals. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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