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Topical

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This product has been discontinued

Active ingredients
  • Capsaicin .0355 g/100 g
  • Menthol 5 g/100 g
  • Methyl Salicylate 20 g/100 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 2011
Label revision date
February 8, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Capsaicin .0355 g/100 g
  • Menthol 5 g/100 g
  • Methyl Salicylate 20 g/100 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 2011
Label revision date
February 8, 2019
Manufacturer
Two Hip Consulting, LLC
Registration number
part348
NDC root
76074-120
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 muscles and joints. It can be helpful for conditions such as arthritis, simple backache, strains, sprains, and muscle soreness or stiffness. It's important to note that while this product can alleviate discomfort, it does not cure any underlying diseases.

Uses

If you're dealing with minor aches and pains in your muscles and joints, this product can help provide temporary relief. It's effective for discomfort related to conditions like arthritis, simple backaches, strains, sprains, and general muscle soreness and stiffness.

Keep in mind that while this product can alleviate these symptoms, it does not cure any diseases. Always consult with a healthcare professional if you have concerns about your pain or underlying conditions.

Dosage and Administration

Before you start using this medication, it's important to test your skin sensitivity. To do this, apply a small amount to a small area of your skin and wait to see if there’s any reaction. If your skin reacts well, you can proceed to use the medication as directed.

When applying the medication, make sure to massage it directly into the affected area. You should not use it more than four times a day. After each application, remember to thoroughly wash your hands to avoid spreading the medication to other areas or to other people. Following these steps will help ensure you use the medication safely and effectively.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow the guidance provided by your healthcare professional and use the medication responsibly.

Side Effects

You should be aware that this product is for external use only and must be used as directed. Avoid getting it in your eyes or on mucous membranes, and do not use it with heating devices or cover the area tightly. If you accidentally swallow it, contact poison control immediately. If the product comes into contact with your eyes, rinse them with cold water and seek medical attention.

It's important to stop using the product and consult a doctor if your condition worsens, if you experience irritation, if pain lasts more than 7 days, or if pain goes away and then comes back. Do not apply it to cuts or infected skin, on children under 12, or in combination with other topical pain products. Additionally, avoid use if you are allergic to any ingredients, PABA, aspirin products, or sulfa, and if you are pregnant or nursing. Store the product in a cool place, below 90°F (32°C).

Warnings and Precautions

This product is for external use only, so be sure to follow the directions carefully. Avoid getting it in your eyes or on mucous membranes, and do not use it with heating devices or cover the area tightly with bandages. If you accidentally swallow the product, contact poison control immediately. If it gets in your eyes, rinse with cold water and seek medical attention.

You should stop using this product and consult your doctor if your condition worsens, if you experience irritation, if pain lasts more than 7 days, or if pain goes away and then comes back. Do not use it on cuts or infected skin, on children under 12, in combination with other topical pain products, or if you are allergic to any of the ingredients, including PABA, aspirin products, or sulfa. Additionally, avoid using it if you are pregnant or nursing, and store it in a cool place below 90°F (32°C).

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it's important to act quickly. Call your local poison control center immediately for guidance. They can provide you with the necessary steps to take based on the specific situation.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek medical help right away. Remember, it's always better to be safe and get professional advice in these situations.

Pregnancy Use

If you are pregnant or nursing, it is important to avoid using this medication. The potential risks to your health and the health of your baby are significant, and it is best to consult with your healthcare provider for safer alternatives. Always prioritize your well-being and that of your child when considering any medication during this time.

Lactation Use

If you are breastfeeding, it is important to know that this medication should not be used while you are nursing. There are potential risks associated with its use during breastfeeding, and it is best to avoid it to ensure the safety of both you and your baby. Always consult with your healthcare provider for guidance on medications and breastfeeding to make informed decisions for your health and your child's well-being.

Pediatric Use

It's important to know that this medication should not be given to children under 12 years old. If you have younger children, make sure to keep this medication out of their reach to prevent any accidental ingestion. Always consult with your healthcare provider if you have questions about the appropriate use of this medication for your child.

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, it’s important to consult with a healthcare provider for personalized advice. 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.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

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 affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help you understand how to manage your health while considering your liver condition.

Drug Interactions

It's important to be cautious when using this medication, especially regarding its interactions with other treatments. You should avoid using it alongside other topical pain products, as combining these can lead to unwanted effects.

While there are no specific interactions with laboratory tests noted, it's always a good idea to discuss any medications you are taking with your healthcare provider. They can help ensure that your treatment plan is safe and effective, taking into account all the medications and tests you may be involved with.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool place, keeping the temperature below 90 degrees Fahrenheit (32 degrees Celsius). This helps maintain its effectiveness and integrity.

When handling the product, always do so with clean hands and in a clean environment to avoid contamination. If you have any specific disposal instructions, be sure to follow them carefully to ensure safe and responsible disposal.

Additional Information

You should apply this medication topically, directly massaging it into the affected area. Make sure not to use it more than four times a day. Before your first use, it's important to test your skin sensitivity by applying a small amount to a discreet area. After applying the medication, remember to wash your hands thoroughly to avoid any unintended contact with other areas of your body or with others.

FAQ

What is this product used for?

This product is for the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains, muscle soreness, and stiffness. It does not cure any diseases.

How should I use this product?

Apply and massage it directly to the affected area, and do not use more than 4 times a day. Prior to first use, test skin sensitivity by applying a small amount.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Avoid contact with eyes and mucous membranes, and do not use with heating devices or cover tightly.

What should I do if I experience irritation or if my condition worsens?

Discontinue use and consult a physician if your condition worsens, irritation develops, or if pain persists for more than 7 days.

Can I use this product on children?

No, do not use this product on children less than 12 years old.

Is it safe to use this product if I am pregnant or nursing?

No, do not use this product if you are pregnant or nursing.

How should I store this product?

Store the product below 90 degrees F (32 degrees C).

What should I do if I accidentally swallow this product?

If swallowed, call poison control immediately.

Packaging Info

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

Packaging configurations for Topical.
Details

Drug Information (PDF)

This file contains official product information for Topical, 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 additional specific description details are provided in the available data.

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 arthritis, simple backache, strains, sprains, muscle soreness, and stiffness.

Limitations of Use: This product does not cure any diseases.

Dosage and Administration

Healthcare professionals should instruct patients to use the product only as directed. Prior to the first application, it is essential to test for skin sensitivity by applying a small amount of the product to a limited area of skin.

The product should be applied directly to the affected area and gently massaged in. It is important to limit the application to a maximum of four times per day. After each application, patients must thoroughly wash their hands to prevent unintentional contact with other areas of the body or with other individuals.

Contraindications

Use is contraindicated in individuals who cannot ensure the product is kept out of reach of children. This precaution is necessary to prevent accidental ingestion or misuse by pediatric populations. No other contraindications have been identified.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. It is imperative to avoid contact with the eyes and mucous membranes. The application of heating devices or pads in conjunction with this product is contraindicated. Additionally, the area of application should not be covered or bandaged tightly. In the event of accidental ingestion, immediate contact with poison control is advised. Should contact with the eyes occur, it is essential to rinse thoroughly with cold water and seek medical attention.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens or if irritation develops. Persistent pain lasting more than 7 days warrants medical evaluation, as does any recurrence of pain after initial resolution.

This product is not recommended for use on cuts or infected skin, in children under 12 years of age, or in combination with other topical pain relief products. Patients with known allergies to any ingredients, including PABA, aspirin products, or sulfa, should avoid this product. Furthermore, it is contraindicated for use during pregnancy or while nursing. Proper storage is crucial; the product should be kept below 90 degrees F (32 degrees C) in accordance with USP Controlled Temperature guidelines.

Side Effects

Patients should be aware that the product is for external use only and must be used strictly as directed. It is important to avoid contact with the eyes and mucous membranes. The use of heating devices or pads in conjunction with this product is contraindicated, and patients should not cover or bandage the area tightly. In the event of accidental ingestion, it is advised to contact poison control immediately.

Should contact with the eyes occur, patients are instructed to rinse the eyes with cold water and seek medical attention. Discontinuation of use and consultation with a physician is recommended if any of the following occur: the condition worsens or irritation develops, pain persists for more than 7 days, or if pain resolves and then redevelops.

The product should not be applied to cuts or infected skin, nor should it be used on children under 12 years of age. It is also contraindicated for use in combination with other topical pain products and in individuals with known allergies to any ingredients, including PABA, aspirin products, or sulfa. Additionally, pregnant or nursing individuals should refrain from using this product.

For optimal storage, the product should be kept below 90 degrees F (32 degrees C).

Drug Interactions

The use of this product in conjunction with other topical pain products is contraindicated. Co-administration may lead to an increased risk of adverse effects or diminished therapeutic efficacy.

No specific interactions with laboratory tests have been identified. Therefore, routine monitoring of laboratory parameters is not necessary when using this product.

Packaging & NDC

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

Packaging configurations for Topical.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. It is important to keep the product out of reach of children to prevent accidental ingestion or misuse.

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 nursing should not use this medication. The potential risks associated with the use of this drug during pregnancy have not been established, and its safety profile in this population remains unclear. Therefore, healthcare professionals are advised to counsel women of childbearing potential regarding the importance of avoiding this medication during pregnancy and while breastfeeding.

Lactation

Lactating mothers are advised against the use of this medication while nursing. There is no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is warranted, and alternative treatments should be considered for 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 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 action is crucial. If the substance is ingested, it is imperative to contact poison control for guidance. Healthcare professionals should be prepared to provide detailed information regarding the patient's condition and the amount of the substance consumed.

Potential symptoms of overdosage may vary depending on the specific substance involved. It is essential for healthcare providers to monitor the patient closely for any signs of toxicity or adverse reactions.

Management of overdosage should be tailored to the individual case, taking into account the specific substance and the severity of symptoms. Supportive care may be necessary, and interventions should be guided by the recommendations from poison control and relevant clinical protocols.

Nonclinical Toxicology

The use of this product is contraindicated in pregnant or nursing individuals due to potential teratogenic effects. In cases where non-teratogenic effects are observed, it is advised to discontinue use and seek medical consultation if the condition worsens or if irritation develops. Additionally, individuals should consult a physician if pain persists for more than seven days or if pain resolves and then redevelops.

No information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Furthermore, there is no data provided on animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of storing the medication in a secure location, away from the sight and reach of young children. This precaution helps ensure the safety of both the patient and others in the household.

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 in a controlled environment, maintaining a temperature below 90 degrees Fahrenheit (32 degrees Celsius) to ensure its stability and efficacy. Proper storage conditions are critical to preserving the integrity of the product throughout its shelf life.

Additional Clinical Information

The product is administered topically, with application directly to the affected area. Patients should not exceed four applications per day. Prior to the first use, it is recommended that patients test for skin sensitivity by applying a small amount of the product. Additionally, patients should thoroughly wash their hands after each application to prevent unintended exposure.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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