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Cannabicool Pain Relieving Lidocaine Roll-on

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 40 mg/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 2019
Label revision date
January 14, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 40 mg/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 2019
Label revision date
January 14, 2022
Manufacturer
Market America, Inc.
Registration number
part348
NDC root
76209-567
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 can use this medication for the temporary relief of pain and itching. It is designed to help alleviate discomfort, making it easier for you to manage symptoms associated with various conditions. If you're experiencing pain or itching, this drug may provide the relief you need.

Uses

You can use this medication for the temporary relief of pain and itching. Whether you're dealing with discomfort from a minor injury, an insect bite, or another source of irritation, this treatment can help soothe your symptoms. It's designed to provide quick relief, allowing you to feel more comfortable in your daily activities.

Dosage and Administration

You can use this medication to treat the affected area on your skin. For adults and children over 12 years old, apply it no more than 3 to 4 times a day. If the medicine accidentally gets on your hands, be sure to wash them with soap and water right away to avoid any irritation.

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

What to Avoid

If you are allergic to any of the ingredients in this product, you should not use it. Additionally, avoid using it in large quantities, especially on raw surfaces or blistered areas.

While using this product, be careful to avoid contact with your eyes, and do not apply it to wounds or damaged skin. It's also important not to bandage the area tightly after application. Following these guidelines will help ensure your safety and the effectiveness of the product.

Side Effects

You should only use this product on the outside of your body. If your condition gets worse, or if your symptoms last longer than 7 days, or if they improve and then come back within a few days, it's important to stop using the product and consult a doctor.

Warnings and Precautions

This product is for external use only, so please avoid using it on any internal areas of your body. It's important to keep it out of reach of children. If someone accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

You should stop using this product and call your doctor if your condition worsens, if your symptoms last longer than 7 days, or if your symptoms improve and then come back within a few days. Your health and safety are important, so don’t hesitate to reach out for help if you need it.

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 action can make a significant difference.

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 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, you can apply the medication to the affected area, but be sure not to exceed 3 to 4 applications per day. Always follow these guidelines to ensure the safety and effectiveness of the treatment 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 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 your medication dosage may need to be adjusted. This is because renal impairment can affect how your body processes certain drugs. Regular monitoring of your renal function tests is essential to ensure your kidneys are working properly and to help guide any necessary changes in your treatment.

If your creatinine clearance (a measure of kidney function) is decreased, your healthcare provider may recommend a reduced dose of your medication. Staying in close communication with your doctor about your kidney health will help ensure you receive the safest and most effective care.

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 you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always feel free to ask questions and share any concerns you may have regarding your medications or tests. Your healthcare provider is there to help you understand how to manage your health safely.

Storage and Handling

To ensure your safety and the effectiveness of the product, it is important to store it properly. Keep the product tightly closed and store it in a cool, dry place, away from any sources of heat or open flames, as it is flammable.

When handling the product, always be cautious and avoid exposing it to fire. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the purpose of this drug?

This drug is used for the temporary relief of pain and itching.

How should adults and children over 12 years use this product?

Apply to the affected area not more than 3 to 4 times daily. If the medicine comes in contact with your hands, wash with soap and water.

What should I do if I am under 12 years old?

If you are under 12 years of age, ask a doctor before use.

What precautions should I take when using this product?

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

Are there any contraindications for this drug?

Do not use this product if you are allergic to any of its ingredients.

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

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

Is this drug safe for external use?

Yes, but it is for external use only. Keep out of reach of children.

What should I do if I accidentally swallow this product?

If swallowed, get medical help or contact a Poison Control Center right away.

Can I use this product if I am pregnant or breastfeeding?

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

How should I store this product?

Store it tightly closed in a cool, dry place and keep away from fire or open flame, as it is flammable.

Packaging Info

Below are the non-prescription pack sizes of Cannabicool Pain Relieving Lidocaine Roll-on (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cannabicool Pain Relieving Lidocaine Roll-on.
Details

Drug Information (PDF)

This file contains official product information for Cannabicool Pain Relieving Lidocaine Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No specific information related to the Description section for SPL code 34089-3 is provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching. It is intended for use in patients experiencing these symptoms due to various conditions.

Dosage and Administration

Adults and children over 12 years of age should apply the medication to the affected area no more than 3 to 4 times daily. In the event that the medicine comes into contact with the hands, it is recommended to wash the hands thoroughly with soap and water.

For children under 12 years of age, it is advised to consult a physician before 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 in large quantities, especially over raw surfaces or blistered areas, due to the potential for exacerbating irritation or injury.

Contact with the eyes must be avoided, and the product should not be applied to wounds or damaged skin to prevent adverse reactions. Furthermore, tight bandaging of the area where the product is applied is contraindicated to ensure proper circulation and avoid additional skin irritation.

Warnings and Precautions

For external use only. This product is not intended for internal use, and caution should be exercised to prevent accidental ingestion.

General precautions must be observed to ensure safety. It is imperative to keep this product out of reach of children. In the event of accidental swallowing, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Healthcare professionals should advise patients to discontinue use and consult a physician 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. These actions are crucial to ensure patient safety and effective management of their condition.

Side Effects

Patients should be aware that the product is intended for external use only.

In clinical practice, it is advised that patients discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. These recommendations are based on safety considerations to ensure appropriate management of adverse reactions.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Cannabicool Pain Relieving Lidocaine Roll-on (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cannabicool Pain Relieving Lidocaine Roll-on.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 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 potential adverse effects or changes in efficacy, 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 evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

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 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 may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests regularly in these individuals to assess their kidney status. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects associated with impaired renal function.

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. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. It is crucial for healthcare professionals to consult relevant toxicology resources or poison control centers for guidance on the appropriate management strategies tailored to the specific situation.

Overall, vigilance and prompt intervention are key components in the effective management of overdose cases.

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 understanding of potential risks associated with the compound in nonclinical settings.

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. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing potential risks associated with accidental exposure.

Storage and Handling

This product is classified as flammable and must be kept away from fire or open flame to ensure safety. It should be stored tightly closed in a cool, dry place to maintain its integrity and effectiveness. Proper storage conditions are essential to prevent any potential hazards associated with its flammable nature.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Cannabicool Pain Relieving Lidocaine Roll-on, 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 Cannabicool Pain Relieving Lidocaine Roll-on, 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.