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Sincere Pain Relief

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This product has been discontinued

Active ingredients
  • Menthol 2 g/100 g
  • Methyl Salicylate 2 g/100 g
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 2013
Label revision date
October 13, 2016
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 2 g/100 g
  • Methyl Salicylate 2 g/100 g
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 2013
Label revision date
October 13, 2016
Manufacturer
Jiangsu Jiangsu Sincere Pharmaceutical Co. , Ltd
Registration number
part348
NDC root
70836-001
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 provide temporary relief from minor aches and pains in your muscles and joints. It can be particularly helpful for conditions such as simple backache, arthritis, sprains, strains, and bruises. If you're experiencing discomfort from any of these issues, this drug may offer you some relief.

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 backache, arthritis, sprains, strains, and bruises. This means if you're experiencing discomfort from any of these issues, this medication may help alleviate your pain and improve your comfort.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those who may be concerned about such risks.

Dosage and Administration

To use this medication effectively, start by cleaning and drying the area of your skin that needs treatment. Once the skin is ready, peel off the protective transparent film from the patch and apply the gel side directly to the affected area. The patch works by providing cold compression, so you might feel a cooling sensation when it’s on your skin. Remember to remove the patch after a maximum of 12 hours.

If you are using this medication for a child under 12 years old, it’s important to consult a doctor before application to ensure it’s safe and appropriate for their use.

What to Avoid

If you are allergic to any ingredients in this product, you should not use it. Additionally, it’s important to avoid applying the product on wounds or damaged skin, and do not use it alongside other external pain relief products. Always follow the directions provided and avoid using it in ways not specified. Be careful to keep the product away from your eyes, mucous membranes, and any rashes to prevent irritation.

Using this product improperly can lead to issues such as misuse or dependence (a condition where you may feel a compulsive need to use a substance). Always prioritize your safety and well-being by adhering to these guidelines.

Side Effects

This product is intended for external use only, so it's important to avoid applying it to wounds or damaged skin. You should not use it alongside other external pain relief products or if you have an allergy to any of its ingredients. Always follow the directions provided and steer clear of contact with your eyes, mucous membranes, or any rashes.

While no specific side effects were mentioned, it's essential to be cautious and discontinue use if you experience any unusual reactions. If you have any concerns or questions about using this product, consult with a healthcare professional.

Warnings and Precautions

This product is for external use only, so please do not apply it to any internal areas. It's important to keep this product out of reach of children to ensure their safety.

You should stop using this product and call your doctor if you have any wounds or damaged skin, if you are allergic to any of its ingredients, or if you are using other external pain relief products at the same time. Additionally, avoid contact with your eyes, mucous membranes, or any rashes, and always use the product as directed. If you experience any concerning symptoms, seek medical attention promptly.

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 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 unsure, 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 be safe and get checked by a healthcare professional if you have any concerns about 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 this product has not been evaluated for safety during pregnancy. In fact, its use is contraindicated, meaning it should not be used while pregnant due to potential risks to your developing baby. There are no specific studies available that examine how ingredients like menthol and methyl salicylate may affect pregnancy or fetal development.

Before considering the use of this product, you should consult your healthcare provider. They can provide guidance tailored to your individual situation, ensuring the safety of both you and your baby. Remember, it's always best to prioritize your health and that of your child during this important time.

Lactation Use

If you are breastfeeding, it's important to be cautious when considering the use of this product, as it may be excreted in breast milk. This means that some of the ingredients could potentially pass into your milk and affect your baby. To ensure the safety of both you and your infant, it is highly recommended that you consult with a healthcare professional before using this product while nursing. They can provide personalized advice based on your specific situation.

Pediatric Use

If you have a child under 12 years old, it's important to consult a doctor before using this medication. This ensures that the treatment is safe and appropriate for your child's specific needs. Always prioritize professional guidance when it comes to the health of your little ones.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about dosage or potential side effects with your doctor, as they can provide personalized guidance based on your health history and current medications.

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 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 be cautious when using this medication. You should avoid using it alongside other external pain relief products at the same time, as this can lead to unwanted side effects or reduce the effectiveness of the treatment.

Always discuss any medications you are taking with your healthcare provider, including over-the-counter products, to ensure your safety and the best possible outcomes. While there are no specific interactions with laboratory tests noted, keeping your healthcare team informed about all your medications is essential for effective care.

Storage and Handling

To ensure the best quality and safety of your product, store it in a cool, dry place and keep it sealed. It's important to avoid direct sunlight, as exposure can affect its effectiveness. By following these simple storage guidelines, you can help maintain the integrity of the product for its intended use.

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 about how to use this medication or its effects, be sure to consult your healthcare provider for more information.

FAQ

What is the primary use of this drug?

This drug is used for temporary relief of minor aches and pains of muscles and joints, including conditions like simple backache, arthritis, sprains, strains, and bruises.

Who should not use this product?

You should not use this product if you are allergic to any of its ingredients, on wounds or damaged skin, or with other external analgesic products at the same time.

What should I do if I am pregnant?

If you are pregnant, consult a healthcare provider before using this product, as it has not been evaluated for safety during pregnancy.

Can children use this product?

Children under 12 years of age should consult a doctor before using this product.

How should I apply this product?

For adults and children 12 years and older, clean and dry the affected area, peel off the protective film, apply the gel surface to the area, and remove the patch after a maximum of 12 hours.

What precautions should I take when using this product?

Avoid contact with eyes, mucous membranes, or rashes, and keep it out of reach of children. Store it in a cool, dry place away from direct sunlight.

What should I do if I experience an adverse reaction?

While no specific adverse reactions are detailed, if you experience any unusual symptoms, stop using the product and consult a healthcare professional.

Packaging Info

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

Packaging configurations for Sincere Pain Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

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

Adults and children aged 12 years and older should begin by cleaning and drying the affected areas thoroughly. Following this, the protective transparent film should be peeled off, and the gel surface of the patch should be applied directly to the affected area. The patch should remain in place for a maximum duration of 12 hours. It is important to note that the patch functions through cold compression, and users may experience a cooling sensation during application.

For children under 12 years of age, it is recommended to consult a healthcare professional prior to use.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to any of its ingredients.

Additionally, the product should not be applied to wounds or damaged skin, nor should it be used concurrently with other external analgesic products. It must be used strictly as directed, and contact with the eyes, mucous membranes, or rashes should be avoided.

Warnings and Precautions

For external use only. This product is not intended for internal use and should be applied strictly as directed.

General precautions must be observed to ensure safety. It is imperative to keep this product out of reach of children to prevent accidental ingestion or misuse.

Healthcare professionals should advise patients to seek immediate medical assistance in case of severe reactions or if symptoms worsen.

Patients are instructed to discontinue use and consult their healthcare provider under the following circumstances: if the product is applied to wounds or damaged skin; if it is used concurrently with other external analgesic products; if there is a known allergy to any of the product's ingredients; if the product is used in a manner not directed; or if there is contact with the eyes, mucous membranes, or rashes.

No specific laboratory tests are recommended for monitoring during the use of this product, as no additional information is provided in the insert.

Side Effects

For external use only, this product should not be applied to wounds or damaged skin. It is contraindicated for use with other external analgesic products simultaneously and should not be used by individuals who are allergic to any of its ingredients. The product must be used only as directed, and contact with the eyes, mucous membranes, or rashes should be avoided.

No specific adverse reactions or side effects have been detailed in the available data.

Drug Interactions

Concurrent use of this product with other external analgesic products is contraindicated. The combination may lead to an increased risk of adverse effects without providing additional therapeutic benefit. Therefore, it is advised to avoid simultaneous application of multiple external analgesics.

No specific interactions with laboratory tests have been identified. As such, there are no recommendations for monitoring or adjustments related to laboratory assessments when using this product.

Packaging & NDC

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

Packaging configurations for Sincere Pain Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. The safety and efficacy of this medication in this age group have not been established, and appropriate dosing may vary. It is essential for healthcare providers to evaluate the individual needs of pediatric patients when considering treatment options.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The product has not been evaluated for safety during pregnancy, and its use is contraindicated in pregnant patients due to potential risks to the fetus. There are no specific studies available regarding the effects of menthol and methyl salicylate on pregnancy or fetal development. Consequently, healthcare providers should be consulted before pregnant women consider using this product. No dosage modifications are specified for individuals who are pregnant.

Lactation

Lactating mothers should exercise caution when using this product due to the potential for excretion in breast milk. It is recommended that they consult a healthcare professional before using this product while breastfeeding.

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 this medication to patients with renal impairment.

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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized until the patient stabilizes or further treatment is determined.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is vital for ongoing management and potential reporting requirements.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion or misuse. Patients should be instructed not to apply the product on wounds or damaged skin, as this may lead to adverse effects.

It is important for healthcare providers to inform patients that the product should not be used concurrently with other external analgesic products, as this may increase the risk of side effects. Patients should also be cautioned against using the product if they have a known allergy to any of its ingredients.

Healthcare providers should emphasize the necessity of using the product only as directed. Patients should be made aware to avoid contact with the eyes, mucous membranes, or any rashes, as this could result in irritation or other complications.

Storage and Handling

The product is supplied in a sealed container to ensure its integrity. It is essential to store the product in a cool and dry place, away from direct sunlight, to maintain its efficacy and stability. Proper handling and storage conditions are crucial for preserving the quality of the product.

Additional Clinical Information

The route of administration for the product is topical. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Sincere Pain Relief, 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 Sincere Pain Relief, 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.