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Tricylate

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Active ingredients
  • Menthol, Unspecified Form 20 mg/1 g
  • Methyl Salicylate 100 mg/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
October 13, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol, Unspecified Form 20 mg/1 g
  • Methyl Salicylate 100 mg/1 g
Other brand names
Dosage form
Cream
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 2024
Label revision date
October 13, 2025
Manufacturer
Trifluent Pharma LLC
Registration number
M017
NDC root
73352-575
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

TRIFLUENT PHARMA™ is a topical analgesic cream designed to provide temporary relief from minor aches and pains in muscles and joints. It contains 2% menthol, which creates a cooling sensation, and 10% methyl salicylate, which helps to soothe discomfort. This cream is commonly used for conditions such as simple backache, arthritis, strains, bruises, and sprains.

By applying TRIFLUENT PHARMA™ directly to the affected area, you can experience relief from pain and discomfort, allowing you to continue with your daily activities more comfortably.

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, strains, bruises, and sprains. If you're dealing with any of these discomforts, this medication may help ease your symptoms and improve your comfort.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

It's important to use this medication only as directed by your healthcare provider. Avoid applying it to wounds or damaged skin, and do not bandage the area tightly. Additionally, make sure to keep it away from your eyes to prevent irritation. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

This product is intended for external use only, so it's important to follow the directions carefully. While using it, avoid contact with your eyes, and do not apply it to wounds or damaged skin. Additionally, do not wrap the area tightly after application.

If your condition worsens, or if symptoms last more than 7 days or return after clearing up, you should stop using the product and consult a doctor. If you are pregnant or breastfeeding, it's advisable to speak with a healthcare professional before using this product.

Warnings and Precautions

This product is for external use only, so please follow the directions carefully. Keep it out of reach of children to prevent accidental poisoning. If swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Avoid getting the product in your eyes, and do not apply it to wounds or damaged skin. Additionally, do not wrap the area tightly after application.

If your condition worsens, or if symptoms last more than 7 days or return after clearing up, stop using the product and consult your doctor. If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this product.

Overdose

It's important to keep this medication out of reach of children to prevent accidental poisoning. If a child swallows it, you should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

In case of an overdose, you may notice symptoms such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these signs, it's crucial to get medical assistance right away. Always prioritize safety and act quickly in these situations.

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 expert 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 doctor regarding your breastfeeding journey.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without first consulting a doctor. For children aged 2 years and older, you can apply the medication to the affected area, but make sure to do so no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

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 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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand how to manage your treatment effectively.

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 health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at temperatures below 30°C (86°F). This helps maintain its effectiveness and safety.

When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep it in a clean environment to ensure it remains safe for use. If you have any questions about disposal or further handling, consult the guidelines provided with your product.

Additional Information

For adults and children aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, you should not use this medication without consulting a doctor first. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is TRIFLUENT PHARMA™?

TRIFLUENT PHARMA™ is a topical analgesic cream used for the temporary relief of minor aches and pains of muscles and joints.

What are the active ingredients in TRIFLUENT PHARMA™?

It contains 2% Menthol and 10% Methyl Salicylate.

Who can use TRIFLUENT PHARMA™?

Adults and children 2 years of age and older can use it, while children under 2 years should consult a doctor.

How should I apply TRIFLUENT PHARMA™?

Apply to the affected area not more than 3 to 4 times daily.

Are there any contraindications for using TRIFLUENT PHARMA™?

No specific contraindications are mentioned, but do not use otherwise than as directed.

What precautions should I take when using TRIFLUENT PHARMA™?

Avoid contact with eyes, do not apply to wounds or damaged skin, and do not bandage tightly.

What should I do if my condition worsens while using TRIFLUENT PHARMA™?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

Can I use TRIFLUENT PHARMA™ if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

How should I store TRIFLUENT PHARMA™?

Store at temperatures less than 30°C (86°F).

What should I do if TRIFLUENT PHARMA™ is swallowed?

Keep out of reach of children and if swallowed, get medical help or contact a Poison Control Center immediately.

Packaging Info

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

Packaging configurations for Tricylate.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

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, the product should not be used without consulting a healthcare professional.

Contraindications

Use of this product is contraindicated in the following situations:

  • The product should not be used otherwise than as directed.

  • Contact with the eyes must be avoided to prevent irritation or injury.

  • Application to wounds or damaged skin is contraindicated due to the risk of adverse effects.

  • Tight bandaging of the area where the product is applied should be avoided to ensure proper circulation and prevent 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 keep this product out of the reach of children to prevent accidental poisoning. In the event of ingestion, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

Care should be taken to avoid contact with the eyes. The product must not be applied to wounds or damaged skin, and it is advised not to bandage the area tightly after application.

Healthcare professionals should instruct 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.

For individuals who are pregnant or breastfeeding, it is essential to seek advice from a healthcare professional prior to use.

Side Effects

Patients should be aware that this product is for external use only and should not be used otherwise than as directed. When using this product, it is important to avoid contact with the eyes, and it should not be applied to wounds or damaged skin. Additionally, patients should refrain from bandaging the area tightly.

In the event that the condition worsens, or if symptoms persist for more than 7 days or clear up and then occur again within a few days, patients are advised to stop use and consult a doctor.

For those who are pregnant or breastfeeding, it is recommended to seek advice from a health professional before using this product.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Tricylate.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication; consultation with a healthcare professional is advised. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

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 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 important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and breastfeeding safety. Healthcare providers should consider individual circumstances and the specific health needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication 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 prescribing information 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 absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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.

Overdosage

In the event of an overdosage, it is crucial to keep the product out of reach of children to prevent accidental poisoning. Should ingestion occur, immediate medical assistance is necessary. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on appropriate management.

Prompt action is essential in cases of suspected overdosage to mitigate potential health risks. Symptoms of overdosage may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

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.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental poisoning. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed to use the medication only as directed and to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

It is important to caution patients to avoid contact with their eyes and to refrain from applying the medication to wounds or damaged skin. Additionally, patients should be advised not to bandage the area tightly after application.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at temperatures below 30°C (86°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

For patients aged 2 years and older, the medication should be applied to the affected area no more than 3 to 4 times daily. It is contraindicated for use in children under 2 years of age, and clinicians are advised to consult a doctor in such cases. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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