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Aveda Active Composition

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This product has been discontinued

Active ingredients
  • Menthol 1.25 mL/50 mL
  • Methyl Salicylate 12.45 mL/50 mL
Other brand names
Dosage form
Liquid
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
March 8, 2011
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 1.25 mL/50 mL
  • Methyl Salicylate 12.45 mL/50 mL
Other brand names
Dosage form
Liquid
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
March 8, 2011
Manufacturer
Aveda Corporation
Registration number
part348
NDC root
57677-005
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

Topical Analgesic is an aromatic oil designed to help relieve tired and sore muscles. This product is typically applied directly to the skin, where it works to soothe discomfort and promote relaxation. If you're looking for a way to ease muscle tension after a long day or intense physical activity, this topical analgesic may be a supportive option for you.

Uses

You can use this topical analgesic aromatic oil to help relieve tired and sore muscles. It’s designed to provide soothing relief, making it a great option for those times when your muscles feel fatigued or overworked.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this product, so it can be used safely without concerns in that regard. Enjoy the comfort it brings to your muscle recovery!

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 your little one. Always follow your healthcare provider's advice regarding dosage and application.

What to Avoid

You should avoid applying this medication to any wounds or damaged skin, as it can cause further irritation or complications. Additionally, do not bandage the area tightly, as this can restrict blood flow and lead to other issues. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid getting it in your eyes, and if your condition worsens or symptoms last longer than 7 days, stop using it and consult a doctor. If you accidentally swallow the product, seek medical help or contact a Poison Control Center immediately. Always use the product as directed to ensure your safety.

Warnings and Precautions

This product is intended for external use only, so please avoid using it in any other way. Be careful not to let it come into contact with your eyes. If you accidentally swallow the product, seek medical help immediately or contact a Poison Control Center.

If your condition worsens, or if your symptoms last longer than 7 days or return after clearing up, stop using the product and reach out to your doctor for further advice. Always follow the directions provided to ensure safe and effective use.

Overdose

If you or someone else has swallowed too much of a 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 hesitate to get help right away. Remember, acting quickly can make a significant difference in the outcome.

Pregnancy Use

There is currently no specific information available about the use of this medication during pregnancy, including safety concerns, dosage adjustments, or any special precautions you should take. If you are pregnant or planning to become pregnant, it is important to discuss any medications you are taking with your healthcare provider to ensure the best care for you and your baby. Always prioritize open communication with your doctor regarding any potential risks.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both you and your infant.

Pediatric Use

This product is intended for external use only, so it's important to keep it out of reach of children to prevent accidental poisoning. If a child swallows any of the product, seek medical help or contact a Poison Control Center immediately.

For children aged 2 years and older, you can apply the product to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it's essential to consult a doctor before use. Always follow these guidelines to ensure your child's safety.

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 may still recommend monitoring for any potential side effects or interactions with other medications you may be taking. 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 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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may need to be adjusted or monitored based on your liver function.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for you, especially if you have concerns about your liver health.

Drug Interactions

It's great to know that there are no known 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

You can feel confident that there are no specific storage or handling instructions for this product or device. This means you can store it in a standard environment without any special requirements.

For safety, always handle the product with clean hands and ensure that any surfaces you use are clean. If you have any questions about proper use or safety, don’t hesitate to reach out for more information.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. 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 postmarketing experiences related to this medication.

FAQ

What is the primary use of Topical Analgesic, Aromatic oil?

Topical Analgesic, Aromatic oil is used to relieve tired, sore muscles.

How should I apply Topical Analgesic, Aromatic oil?

Adults and children 2 years of age and older should apply it to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consult a doctor.

Are there any contraindications for using this product?

Do not apply Topical Analgesic, Aromatic oil to wounds or damaged skin, and do not bandage tightly.

What precautions should I take when using this product?

This product is for external use only. Avoid contact with eyes and do not use otherwise than as directed.

What should I do if I accidentally swallow the product?

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

What should I do if my condition worsens or does not improve?

If your condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.

Is there any information regarding use during pregnancy or nursing?

There is no specific information provided regarding the use of this product during pregnancy or nursing.

How should I store Topical Analgesic, Aromatic oil?

No specific storage instructions are provided, but keep it out of reach of children to avoid accidental poisoning.

Packaging Info

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

Packaging configurations for Aveda Active Composition.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The active composition is presented in a bottle format. The media type associated with the product is image/jpeg, with a reference file labeled ACBTL1.jpg.

Uses and Indications

This drug is indicated as a topical analgesic for the relief of tired and sore muscles. It is formulated as an aromatic oil, providing localized comfort to affected areas.

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

Application is contraindicated on wounds or damaged skin due to the potential for adverse effects. Additionally, tight bandaging is contraindicated as it may compromise circulation and lead to further complications.

Warnings and Precautions

For external use only, this product should not be used in any manner other than as directed. It is imperative to avoid contact with the eyes to prevent irritation or injury.

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 the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. These precautions are essential to ensure the safe and effective use of the product.

Side Effects

Patients should be aware that the product is intended for external use only and should not be used otherwise than as directed. It is important to avoid contact with the eyes to prevent irritation or adverse effects.

In clinical practice, if a patient's condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is advised to discontinue use of the product and consult a healthcare professional.

In the event of accidental ingestion, patients are instructed to seek medical help or contact a Poison Control Center immediately. These precautions are essential to ensure the safe use of the product and to mitigate any potential adverse reactions.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Aveda Active Composition.
Details

Pediatric Use

For external use only. Pediatric patients should be kept out of reach of children to prevent accidental poisoning. In the event of ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

For dosing, the product is indicated for use in adults and children aged 2 years and older, with application to the affected area not exceeding 3 to 4 times daily. For children under 2 years of age, consultation with a healthcare provider is recommended prior to use.

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 specific information available regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of informing their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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 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 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; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental poisoning. It is important to instruct patients not to apply the product to wounds or damaged skin and to avoid tight bandaging of the area where the product is applied.

Patients should be informed that if their condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, they should discontinue use of the product and consult a doctor. Additionally, healthcare providers should emphasize the importance of seeking medical help or contacting a Poison Control Center immediately if the product is swallowed.

Storage and Handling

The product is available in various package configurations, with specific NDC numbers assigned for identification. Storage and handling instructions are not explicitly provided; therefore, standard practices for pharmaceutical products should be followed. It is advisable to store the product in a controlled environment, ensuring that it is kept at appropriate temperature ranges to maintain its integrity. Containers should be kept sealed and protected from light and moisture to prevent degradation. Special handling requirements are not specified, but general precautions should be taken to ensure the product's quality and safety during storage and transportation.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, consultation with a doctor is advised prior to use. 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 Aveda Active Composition, 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 Aveda Active Composition, 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.