Pomg Night Time Pain Relief Roller

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of pain in muscles, joints, and tendons.

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

Dosage and Administration

For adults and children aged 12 years and older, a thin film of the product should be applied to the desired area before bedtime. It is important to ensure that the application is even and covers the intended area adequately.

For children under 12 years of age, it is recommended to consult a healthcare professional prior to use to determine the appropriate course of action.

After application, hands should be washed thoroughly with soap and water to prevent accidental contact with other areas of the body or with other individuals.

Contraindications

Use of this product is contraindicated in the following situations:

• In individuals with a known allergy to any ingredient in this product, due to the risk of allergic reactions.

• On open sores and wounds, as this may exacerbate irritation or lead to infection.

• In large quantities, as excessive use may result in adverse effects.

Warnings and Precautions

For external use only. This product is contraindicated in individuals with known allergies to any of its ingredients. It should not be applied to open sores or wounds, nor should it be used in large quantities.

Healthcare professionals should advise patients to discontinue use and seek medical consultation if any of the following occur: worsening of conditions or persistence of symptoms beyond 7 days; recurrence of symptoms after initial improvement within a few days; presence of redness or excessive skin irritation; severe burning pain, swelling, or blistering at the application site; or any signs of an allergic reaction.

In the event of accidental ingestion, it is imperative to keep this product out of reach of children and pets. Immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients should be aware that this product is intended for external use only. It is contraindicated for individuals who are allergic to any of its ingredients, and it should not be applied to open sores or wounds, nor used in large quantities.

When using this product, it is essential to follow the directions provided. Patients should avoid bandaging the area tightly and should take care to prevent contact with the eyes and other mucous membranes. Additionally, exposure of the treated area to external heat or direct sunlight should be avoided.

Patients are advised to discontinue use and consult a doctor if any of the following occur: conditions worsen or symptoms persist for more than 7 days; symptoms resolve and then recur within a few days; redness or excessive skin irritation develops; severe burning pain, swelling, or blistering occurs at the application site; or if an allergic reaction is suspected.

For pregnant or breastfeeding individuals, it is recommended to consult a doctor prior to use. This product should be kept out of reach of children and pets. In the event of accidental ingestion, immediate medical assistance should be sought or the Poison Control Center should be contacted.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Pomg Night Time Pain Relief Roller (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor prior to use. For adolescents and adults aged 12 years and older, the recommended application is to rub a thin film over the desired area before bedtime.

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 breastfeeding should consult a healthcare professional prior to using this medication. It is essential 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 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, it is imperative to keep the product out of reach of children and pets to prevent accidental ingestion. Should ingestion occur, immediate medical assistance should be sought. Healthcare professionals are advised to contact the Poison Control Center without delay for guidance on appropriate management.

Prompt action is crucial in mitigating potential adverse effects associated with overdosage. The symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage any clinical manifestations that arise.

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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, severe burning pain, swelling, and blistering at the application site.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children and pets to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should seek medical help or contact the Poison Control Center immediately. It is important for patients to understand the potential risks associated with improper use and to take necessary precautions to ensure safety.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy.

To ensure optimal preservation, the product must be protected from light exposure. Additionally, it is crucial to keep the container tightly closed when not in use to prevent contamination and degradation.

Healthcare professionals should be aware that the product should be discarded after opening if it is not used within a specified time frame, although the exact duration is not provided in the current information.

Additional Clinical Information

Patients aged 12 years and older are advised to apply a thin film of the product over the desired area before bedtime. For children under 12 years of age, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients to consult a doctor if they are pregnant or breastfeeding before using the product. It is also important to keep the product out of reach of children and pets; in the event of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Pomg Night Time Pain Relief Roller, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)