Painpatrol Cbd Pain Relief with Lidocaine

Description

PainPatrol™ is a pain relief cream formulated with cannabidiol (CBD) and contains 200 mg of CBD per 2 oz. (57 g) of product. This formulation incorporates Lidocaine to enhance its analgesic properties. The cream is designed for odor-free application and utilizes Deep Dermal Delivery Technology™ to facilitate effective penetration into the skin for targeted relief.

Uses and Indications

This drug is indicated for use as a topical anesthetic.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children over 12 years of age should apply the product generously to the affected area. The application should be followed by a gentle massage into the painful area until the product is thoroughly absorbed into the skin. This process may be repeated as necessary, but should not exceed four applications in a 24-hour period.

For children 12 years of age or younger, it is advised to consult a physician before use.

Contraindications

The product should not be used in the following situations:

• Bandaging tightly or using with a heating pad is contraindicated due to the risk of impaired circulation and potential skin damage.

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

• Application to wounds or damaged skin is contraindicated to reduce the risk of adverse reactions and complications.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid contact with eyes and mucous membranes.

Patients with a known allergy to aspirin or salicylates should consult their healthcare provider prior to use to assess the risk of an allergic reaction.

It is imperative to keep this product out of the reach of children. In the event of accidental ingestion, immediate medical attention should be sought by contacting a doctor or poison control center.

Patients are instructed to discontinue use and consult a healthcare professional if the condition worsens, symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days. Additionally, if redness or irritation develops, medical advice should be sought promptly.

Side Effects

For external use only. Patients should be aware of the potential for allergic reactions, particularly those who are prone to allergies from aspirin or salicylates; such individuals are advised to consult their doctor prior to use.

In clinical practice, patients are instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than seven days, if the condition clears up and then recurs within a few days, if redness is present, or if irritation develops. These guidelines are essential to ensure patient safety and to mitigate the risk of adverse reactions.

Drug Interactions

Patients with a known hypersensitivity to aspirin or salicylates should consult their healthcare provider prior to initiating treatment. This precaution is essential to avoid potential allergic reactions.

There are no specific interactions identified between the drug and laboratory tests, indicating that routine laboratory assessments are unlikely to be affected by the use of this medication.

Packaging & NDC

Below are the non-prescription pack sizes of Painpatrol Cbd Pain Relief with Lidocaine (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional prior to use. It is important for caregivers to seek medical advice to ensure the safety and appropriateness of the treatment for this age group.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management strategies tailored to the substance involved.

Documentation of the incident, including 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 potential effects 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. Instruct patients that if the medication is accidentally swallowed, they should contact a doctor or poison control center immediately.

Patients should be informed to stop using the medication and consult a doctor if their condition worsens or if symptoms persist for more than seven days. They should also seek medical advice if symptoms clear up and then reoccur within a few days, or if they experience redness or irritation.

It is essential to emphasize that patients should use the medication only as directed. They should be cautioned against bandaging the area tightly or using the medication in conjunction with a heating pad. Additionally, patients must avoid contact with their eyes or mucous membranes and should not apply the medication to wounds or damaged skin.

Storage and Handling

The product is supplied in a container that must be stored in a cool, dry place. It is essential to ensure that the cap is tightly closed to maintain the integrity of the product. Proper storage conditions are crucial for preserving the quality and efficacy of the product.

Additional Clinical Information

The product is administered topically. For adults and children over 12 years of age, it should be applied generously to the affected area and massaged into the skin until fully absorbed. This application may be repeated as necessary, but should not exceed four times a day. For children 12 years or younger, it is advised to consult a doctor before 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 Painpatrol Cbd Pain Relief with Lidocaine, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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