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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

Imbue 1 is a medication designed to temporarily relieve minor aches and pains in muscles and joints. It can be helpful for various conditions, including simple backache, muscle strain, sprains, arthritis, bruises, bursitis, and tendinitis. This means that if you're experiencing discomfort from any of these issues, Imbue 1 may provide you with some relief.

Uses

You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. It is effective for various conditions, including simple backaches, muscle strains, sprains, arthritis, bruises, bursitis, and tendinitis.

This means that if you're dealing with discomfort from any of these issues, this medication may help ease your pain and improve your mobility. Always consult with a healthcare professional if you have any questions or concerns about your symptoms or treatment options.

Dosage and Administration

To use the patch effectively, start by carefully peeling off the clear film without letting the sticky side touch itself. Once ready, 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 pain relief to kick in.

For adults and children over 12 years, you can use 1 to 2 patches each day. Make sure to wait 12 to 24 hours before applying any additional patches to prevent skin irritation. After applying the patch, remember to 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. If you’re considering using this patch for a child under 12, be sure to consult a doctor first.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should never 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 could lead to further complications.

When using this product, do not bandage tightly or use it in combination with a heating pad, as this may increase the risk of adverse effects. Always follow these guidelines 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. If you notice that your condition worsens, experience severe skin irritation, or if pain lasts longer than 7 days, you should stop using the product and consult a doctor. These steps will help ensure your safety and well-being while using the medication.

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 more than 7 days. It's important to take these precautions seriously to ensure your safety and well-being.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific details provided about the signs of an overdose, common symptoms can include unusual 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 safety and 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

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 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and tests during your appointments.

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, make sure to always re-seal the pouch they come in. This prevents exposure to air and moisture, which can compromise their quality. By following these simple storage and handling tips, you can help ensure that your product remains safe and effective for use.

Additional Information

You should apply 1 to 2 patches of this medication to your skin each day. Make sure to wait 12 to 24 hours before applying any additional patches to prevent skin irritation. If you are pregnant or breastfeeding, it's important to 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 Imbue 1 used for?

Imbue 1 temporarily relieves minor aches and pains of muscles and joints, including conditions like simple backache, muscle strain, sprains, arthritis, bruises, bursitis, and tendinitis.

How should I use Imbue 1 patches?

Peel the clear film off the patch and place the sticky surface on the painful area of your skin. You can use 1 to 2 patches per day, leaving them in place for up to 8 hours.

Are there any warnings for using Imbue 1?

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

What should I do if my condition worsens while using Imbue 1?

Stop using Imbue 1 and ask a doctor if your condition worsens, if severe skin irritation develops, or if pain persists for more than 7 days.

Can children use Imbue 1?

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

What should I do if I swallow Imbue 1?

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

Is there any information about using Imbue 1 during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health care professional before using Imbue 1.

How should I store Imbue 1 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 of muscles and joints associated with various conditions, including 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 directly 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 waiting period 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 healthcare professional before use.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application to the eyes or mucous membranes is prohibited due to the potential for irritation or injury.

  • 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 heating pads is contraindicated to avoid increased risk of adverse effects.

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 the 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 further evaluation and management.

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

Side Effects

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

In clinical practice, it is advised that patients discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, severe skin irritation develops, or if pain persists for more than 7 days. These reactions warrant immediate medical attention to ensure appropriate management and to prevent further complications.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

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 precaution is essential to ensure safety and appropriateness of treatment in this age group.

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 potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety profile in these populations has not been fully established, and healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

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 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 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 available information.

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, the following management procedures are recommended:

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

  2. Supportive Care: Provide supportive care as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and treatments that may be appropriate based on the substance involved.

  4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement these measures in the event of an overdose, despite the lack of specific information provided.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 doctor 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 use it only as directed. They should be cautioned against getting the product into their eyes or on 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 preserve their effectiveness.

Additional Clinical Information

Patients should be informed that the product is administered topically, with a recommended usage of 1 to 2 patches per day. It is important to wait 12 to 24 hours before applying additional patches to minimize the risk of skin irritation.

Clinicians should counsel patients to consult a healthcare professional if they are pregnant or breastfeeding prior to use. Additionally, patients should be made aware 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.