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Theraid

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This product has been discontinued

Active ingredient
Menthol .04 g/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2013
Label revision date
February 20, 2013
Active ingredient
Menthol .04 g/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2013
Label revision date
February 20, 2013
Manufacturer
SOMBRA COSMETICS INC.
Registration number
part348
NDC root
61577-3710

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

You may find that this medication is designed to temporarily relieve minor aches and pains in your muscles and joints. It is commonly used for conditions such as simple backaches, arthritis, strains, bruises, and sprains. By targeting these discomforts, it helps you feel more comfortable and active in your daily life.

Uses

You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. It is effective for conditions such as simple backaches, arthritis, strains, bruises, and sprains.

Rest assured, there are no teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects noted with this medication. This makes it a safer option for managing your discomfort.

Dosage and Administration

If you are using this medication, apply it directly to the affected area of your skin. For adults and children aged 2 years and older, you should use it no more than 3 to 4 times a day. Make sure to rub the gel in thoroughly until it is completely absorbed into your skin.

If your child is under 2 years old, it's important to consult a doctor before using this medication. Always follow these guidelines to ensure safe and effective use.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, you do not need to worry about any particular restrictions or risks related to these aspects. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid applying it to wounds or damaged skin, and do not bandage tightly over the area. Keep the product out of reach of children and avoid contact with your eyes.

If your condition worsens, if symptoms last longer than 7 days, or if they clear up and then return within a few days, you should stop using the product and consult your doctor.

Warnings and Precautions

This product is for external use only, so please do not apply it to wounds or damaged skin. While using it, avoid wrapping the area tightly and keep it away from your eyes. Make sure to store it out of reach of children to prevent accidental ingestion or misuse.

If your condition worsens, if symptoms last longer than 7 days, or if they seem to improve and then come back within a few days, stop using the product and contact your doctor for further advice. It's important to monitor your symptoms and seek professional guidance if needed.

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, 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

There is currently no information available about the use of Theraid - menthol gel during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert. If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, it's best to approach this with caution. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

When using this medication for children aged 2 years and older, you should apply it to the affected area no more than 3 to 4 times a day. Make sure to rub it in thoroughly until the gel is fully absorbed into the skin.

If your child is under 2 years old, it's important to consult a doctor before using this product. This ensures that you get the right guidance for your child's specific needs.

Geriatric Use

When considering the use of Theraid menthol gel for older adults, it's important to note that the drug insert does not provide specific information about how it may affect this age group. This means there are no special dosage adjustments, safety concerns, or precautions outlined for elderly patients.

As always, if you or a caregiver are considering using this product, it's wise to consult with a healthcare professional to ensure it is appropriate for your individual health needs and circumstances.

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 standard recommendations for the medication do not change based on renal impairment. However, it’s always best to discuss your individual situation with your healthcare provider, as they can offer personalized advice and monitor your health closely.

Make sure to keep your doctor informed about your kidney health, as they may need to adjust your treatment plan based on your overall condition and any other medications you may be taking.

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 safety and effectiveness of the product, store it at room temperature and keep it out of reach of children. This product is intended for external use only, so please do not apply it to wounds or damaged skin. When using it, avoid bandaging tightly, as this can cause discomfort or hinder proper use. Additionally, be careful to avoid contact with your eyes, as this can lead to irritation. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day. Make sure to rub it in thoroughly until the gel is fully absorbed. If you are using it for a child under 2 years old, it's important to consult a doctor first for guidance.

FAQ

What is the primary use of this drug?

This drug temporarily relieves minor aches and pains of muscles and joints associated with simple backaches, arthritis, strains, bruises, and sprains.

How should I apply this drug?

For adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily and rub in thoroughly until the gel is absorbed.

What should I do if I have a child under 2 years old?

Consult a doctor before using this product on children under 2 years of age.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Do not use it on wounds or damaged skin, and avoid contact with eyes.

What should I do if my condition worsens?

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

Is this drug safe to use during pregnancy?

There is no specific information regarding the safety of this drug during pregnancy; consult your doctor for advice.

Can nursing mothers use this product?

Nursing mothers should consult a doctor before using this product, as there is a potential for excretion in breast milk.

How should I store this drug?

Store at room temperature and keep out of reach of children.

Packaging Info

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

Packaging configurations for Theraid.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No specific description details are available for SPL code 34089-3.

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 backaches, arthritis, strains, bruises, and sprains.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 2 years and older should apply the gel to the affected area no more than 3 to 4 times daily. The gel must be rubbed in thoroughly until fully absorbed. For children under 2 years of age, it is advised to consult a doctor prior to use.

The gel is intended for topical application exclusively to the affected area. It is essential to adhere to the recommended frequency of application to ensure safety and efficacy.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

For external use only; this product should not be applied to wounds or damaged skin. When utilizing this product, it is imperative to avoid tightly bandaging the area of application and to prevent contact with the eyes. Additionally, it should be kept out of reach of children to ensure safety.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than seven days, or if symptoms clear up only to recur within a few days.

No specific emergency medical help instructions or general precautions have been provided. Furthermore, there are no laboratory tests recommended for monitoring in relation to the use of this product.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and should not be applied to wounds or damaged skin. While using this product, patients are advised to avoid bandaging tightly and to prevent contact with the eyes. Additionally, it is crucial to keep the product out of reach of children to avoid accidental ingestion or misuse.

Patients should discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if the condition appears to clear up and then recur within a few days. These precautions are essential to ensure the safe and effective use of the product.

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 Theraid (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Theraid.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily, ensuring thorough rubbing until the gel is fully absorbed. For children under 2 years of age, it is advised to consult a doctor prior to use.

Geriatric Use

Elderly patients may not have specific information regarding the use of Theraid menthol gel, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

Due to the absence of clinical findings or data specific to this population, it is advisable for healthcare providers to closely monitor elderly patients for any adverse effects or unusual responses to treatment. Consideration of individual patient factors, including comorbidities and concurrent medications, is essential in managing therapy for this demographic.

Pregnancy

There is no information available regarding the use of Theraid - menthol gel during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider this lack of data when prescribing this product 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 accordingly.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data 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 lack of information necessitates careful clinical judgment and monitoring.

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 implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and intervention strategies.

Documentation of the incident, including the substance involved, the amount ingested, and the time of exposure, 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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage and handling to ensure the safety of young individuals.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability while adhering to safety standards. It is essential to store the product at room temperature to maintain its efficacy.

To ensure safety, the product must be kept out of reach of children. It is intended for external use only and should not be applied to wounds or damaged skin. Care should be taken to avoid bandaging the area tightly, as this may lead to complications. Additionally, contact with the eyes must be strictly avoided to prevent irritation or injury.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being 3 to 4 times daily. Patients should rub the gel into the affected area thoroughly until it is fully absorbed. For children under 2 years of age, consultation with a doctor is advised prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

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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.