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Dr Wolfes Cool Therapy

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This product has been discontinued

Active ingredient
Menthol 0.06 g/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
March 9, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 0.06 g/1 g
Other brand names
Dosage form
Gel
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 2023
Label revision date
March 9, 2023
Manufacturer
SOMBRA COSMETICS INC.
Registration number
part348
NDC root
61577-1020
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

You may find this medication helpful for temporarily relieving minor aches and pains in your muscles and joints. It is commonly used for discomfort associated with simple backaches, strains, bruises, and sprains. If you're dealing with any of these issues, this drug could provide you with some relief.

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, strains, bruises, and sprains. This means if you’ve had a minor injury or are experiencing discomfort from everyday activities, this medication may help ease your pain.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the gel to the affected area of your skin. Make sure to do this no more than 3 to 4 times a day. After applying, rub the gel in thoroughly until it is fully absorbed into your skin.

If your child is under 2 years old, it’s important to consult a doctor before using this medication. They can provide guidance on the best course of action for your child's specific needs.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, you can use this medication without concerns about these particular issues. However, always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should only use it externally and avoid applying it to wounds or damaged skin. If you are pregnant or breastfeeding, consult your healthcare professional before use. While using the product, avoid tightly bandaging the area, keep it away from your eyes, and ensure it is out of reach of children.

If your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days, 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, and avoid using it near any heat sources. If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using this product.

While using this product, make sure to avoid tightly bandaging the area and keep it away from your eyes. Always keep it out of reach of children to ensure their safety. If your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days, stop using the product and contact your doctor for further advice.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme 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 crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult with a healthcare professional before using this medication. They can provide guidance on any potential risks and help you make informed decisions about your health and the health of your baby. Always prioritize open communication with your healthcare provider regarding any medications you may consider during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to talk to your healthcare professional before using this medication. They can help you understand any potential risks and ensure that you make the best choice for your health and your baby’s well-being. Always prioritize open communication with your doctor regarding any medications you may consider while nursing.

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 medication. Always prioritize your child's safety and follow these guidelines closely.

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 may affect you 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 monitor your condition and make any necessary adjustments to your treatment plan.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known interactions with other drugs or laboratory tests. However, even when no interactions are identified, your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions and share any concerns you may have regarding your medications or health tests.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature in a cool, dry place. It's important to keep the container tightly closed to prevent contamination and protect it from excessive heat, which can affect its quality. Avoid freezing the product, as this can damage it.

Once you open the container, be sure to discard any remaining product after use to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should use this product only on the skin and not on wounds or damaged areas. For adults and children aged 2 years and older, apply the gel to the affected area 3 to 4 times a day, rubbing it in until fully absorbed. If you are under 2 years old, consult a doctor before use.

It's important to avoid using this product with a heat source or bandaging tightly. If you are pregnant or breastfeeding, talk to your healthcare professional before using it. Keep the product out of reach of children, and stop using it if your condition worsens, symptoms last more than 7 days, or if symptoms improve and then return within a few days. Avoid contact with your eyes.

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, 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, rubbing in thoroughly until the gel is absorbed.

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

If your child is under 2 years of age, consult a doctor before use.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Do not use on wounds or damaged skin, and avoid contact with eyes. Consult a healthcare professional if pregnant or breastfeeding.

What should I do if my condition worsens or symptoms persist?

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

How should I store this drug?

Store at room temperature, keep the container tightly closed, protect from excessive heat, and do not freeze. Discard after opening.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

Is there any information on drug interactions?

No drug interactions have been found for this drug.

Packaging Info

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

Packaging configurations for Dr Wolfes Cool Therapy.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product associated with SPL code 34089-3 does not have specific description details provided in the text. Further information regarding its chemical composition, molecular weight, dosage form, or appearance is not available.

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, 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 dosage is to apply the gel to the affected area no more than 3 to 4 times daily. The gel should be rubbed in thoroughly until fully absorbed.

For children under 2 years of age, it is advised to consult a healthcare professional before use.

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. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

For external use only. This product should not be applied to wounds or damaged skin, nor should it be used in conjunction with a heat source.

Pregnant or breastfeeding individuals are advised to consult a healthcare professional prior to use to ensure safety for both the mother and child.

During the application of this product, it is important to avoid tight bandaging and to prevent contact with the eyes to minimize the risk of adverse effects.

This product must be kept out of reach of children to prevent accidental ingestion or misuse.

Users should discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is intended for external use only and should not be applied to wounds or damaged skin, nor should it be used in conjunction with a heat source. Pregnant or breastfeeding individuals are advised to consult a healthcare professional prior to use.

While using this product, patients should avoid tightly bandaging the area of application and ensure that the product does not come into contact with the eyes. Additionally, it is crucial to keep the product out of reach of children.

Patients are instructed to discontinue use and consult a healthcare provider if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Dr Wolfes Cool Therapy.
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 infants and children under 2 years of age, it is advised to consult a healthcare professional prior to use.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. It is essential to evaluate the potential risks and benefits of treatment during pregnancy and lactation, as the effects on fetal outcomes and nursing infants are not fully established. Healthcare providers are encouraged to consider individual patient circumstances and available data when advising women of childbearing potential regarding the use of this medication.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this drug 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 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, the following management procedures are recommended:

  1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide supportive care as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

  4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement these measures in the event of an overdose, despite the lack of specific information provided.

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 question.

Postmarketing Experience

No postmarketing experience details are provided in the insert for Dr Wolfes Cool Therapy menthol gel.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Providers should encourage patients to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from excessive heat, and must not be frozen. After opening, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. The gel should be thoroughly rubbed into the affected area until absorbed. For children under 2 years of age, consultation with a healthcare professional is advised prior to use.

Clinicians should counsel patients that the product is for external use only and should not be applied to wounds or damaged skin, nor used in conjunction with a heat source. Pregnant or breastfeeding individuals should seek advice from a healthcare professional before use. Patients are also advised to avoid tight bandaging and contact with the eyes, and to keep the product out of reach of children. They should discontinue use and consult a doctor if the condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days.

Drug Information (PDF)

This file contains official product information for Dr Wolfes Cool Therapy, 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 Dr Wolfes Cool Therapy, 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.