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Osteoarthritica Synergy

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This product has been discontinued

Active ingredient
Menthol 7 mg/50 mL
Other brand names
Dosage form
Oil
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2016
Label revision date
November 15, 2016
Active ingredient
Menthol 7 mg/50 mL
Other brand names
Dosage form
Oil
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2016
Label revision date
November 15, 2016
Manufacturer
PHYTOPIA CO. , LTD.
Registration number
part356
NDC root
70470-1123

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Drug Overview

PainAway is a topical product that combines natural peppermint and balsam Peru oil. It is designed to provide relief from pain when applied to the skin. By gently massaging it around the painful area, you may experience soothing effects that can help alleviate discomfort.

Uses

You can use this medication by applying it directly to your skin and gently massaging it around the area where you feel pain. This method helps target discomfort effectively.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safer option for use, especially if you have concerns about potential risks.

Dosage and Administration

When using this medication, it's important to follow the recommended dosage to ensure safety and effectiveness. For adults, the maximum amount you should take is 5 milliliters (ml) per day. If you are giving this medication to a child, the maximum dosage is 1 ml per day.

Make sure to measure the dosage accurately to avoid taking too much. While the specific method of taking or applying the medication isn't detailed, it's crucial to adhere to these dosage limits for both adults and children. Always consult with a healthcare professional if you have any questions or concerns about how to use this medication properly.

What to Avoid

It's important to use this product safely and effectively. Remember, it is for external use only, so do not apply it internally. If you notice a rash while using the product, stop using it immediately and consult your doctor for further advice.

Additionally, please keep this product out of reach of children to prevent any accidental misuse. Following these guidelines will help ensure your safety while using the product.

Side Effects

When using this product, it's important to remember that it is for external use only. If you notice a rash, you should stop using it and consult your doctor. Additionally, make sure to keep this product out of reach of children to ensure their safety.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to any areas that are not meant for topical treatment. If you notice a rash or any unusual skin reaction while using the product, stop using it immediately and consult your doctor for further advice.

To ensure safety, keep this product out of reach of children. It's important to use it responsibly to prevent any accidental ingestion or misuse.

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, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to err on the side of caution when it comes to your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the drug insert does not provide specific information about the use of this product during pregnancy. There are no warnings indicating that the product is unsafe for use while pregnant, nor are there any known risks to the fetus mentioned. Additionally, there are no special dosage adjustments or precautions outlined for pregnant individuals.

As always, it's best to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that the safety of this product for nursing mothers has not been established. There is a possibility that it could be excreted in breast milk, which means it could potentially affect your baby. Therefore, you should exercise caution when considering the use of this product while nursing. Always consult with your healthcare provider to discuss any concerns and to ensure the best choices for you and your infant.

Pediatric Use

When giving this medication to your child, it's important to remember that the maximum dosage for children is 1 milliliter (ml) per day. Always ensure you do not exceed this limit to keep your child safe. If you have any questions or concerns about the appropriate use of this medication for your child, consult your healthcare provider for guidance.

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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 and safety of your product, it's important to store it properly. Keep it away from excessive heat and direct sunlight, as these conditions can damage the product.

When handling the product, always do so with care to maintain its integrity. Following these simple 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 related to this drug. If you have any specific questions or concerns, it's best to consult your healthcare provider for more information.

FAQ

What is PainAway?

PainAway is a topical product containing natural Peppermint and Balsam Peru Oil, designed for pain relief.

How should I use PainAway?

Apply PainAway on the skin and gently massage around the painful area.

What is the maximum dosage for adults and children?

Adults can use a maximum of 5ml per day, while children should not exceed 1ml per day.

Are there any contraindications for PainAway?

No contraindications are listed for PainAway.

Is PainAway safe to use during pregnancy?

The product does not have specific information regarding use during pregnancy, and no risks to the fetus are mentioned.

Can nursing mothers use PainAway?

The safety of PainAway has not been established in nursing mothers, so caution is advised.

What precautions should I take when using PainAway?

Use PainAway for external use only, stop use if a rash occurs, and keep it out of reach of children.

Are there any known drug interactions with PainAway?

No specific drug interactions are mentioned for PainAway.

How should I store PainAway?

Protect PainAway from excessive heat and direct sunlight.

Packaging Info

Below are the non-prescription pack sizes of Osteoarthritica Synergy (osteoarthritica). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Osteoarthritica Synergy.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

PainAway is a topical formulation designed for pain relief, incorporating natural ingredients such as Peppermint and Balsam Peru Oil. The product is intended for external use and is characterized by its specific formulation aimed at alleviating discomfort. The effective time for this product is noted as April 1, 2016.

Uses and Indications

This drug is indicated for topical application to the skin, with gentle massage around the painful area to alleviate discomfort.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

For adults, the recommended dosage is a maximum of 5 mL per day. In pediatric patients, the maximum dosage is 1 mL per day.

Healthcare professionals should ensure that the administration adheres to these specified maximum dosages to avoid potential adverse effects. The route and method of administration have not been specified; therefore, practitioners should follow standard protocols for the delivery of the medication as appropriate for the formulation and patient population.

Contraindications

Use of this product is contraindicated for external use only. It should not be applied to broken or irritated skin. If a rash occurs, discontinue use and consult a healthcare professional. Additionally, this product must be kept out of reach of children to prevent accidental ingestion or misuse.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to discontinue use and consult a physician if a rash develops during treatment. It is imperative to keep this product out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware that the product is intended for external use only. In the event of a rash occurring, it is advised to discontinue use and consult a healthcare professional. Additionally, the product should be kept out of reach of children to prevent accidental ingestion or misuse.

Drug Interactions

No specific drug interactions have been identified for this medication. 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 Osteoarthritica Synergy (osteoarthritica). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Osteoarthritica Synergy.
Details

Pediatric Use

Pediatric patients are advised to limit the dosage to a maximum of 1 mL per day. This dosage recommendation is applicable to children, ensuring safety and efficacy in this population. Careful adherence to this limit is essential to avoid potential adverse effects.

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.

Pregnancy

Pregnant patients should be aware that no specific information regarding the use of this product during pregnancy is provided in the drug insert. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding use during pregnancy are mentioned. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

The safety of this product has not been established in nursing mothers. There is a potential for excretion in breast milk; therefore, caution should be exercised when administering this product to lactating mothers.

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 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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of antidotes or specific treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment 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 text.

Patient Counseling

Healthcare providers should advise patients that the product is intended for external use only. Patients should be instructed to discontinue use and consult their healthcare provider if a rash occurs. Additionally, it is important to emphasize the necessity of keeping the product out of reach of children to prevent accidental ingestion or misuse.

Storage and Handling

This product is supplied in packaging that ensures its integrity during storage and handling. It is essential to protect the product from excessive heat and direct sunlight to maintain its efficacy and safety. Proper storage conditions should be observed to prevent degradation.

Additional Clinical Information

The route of administration for the medication 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 Osteoarthritica Synergy, 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 Osteoarthritica Synergy, 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

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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.