Pain Relief Roll-on

Description

Lidocaine 4% HCl is a topical analgesic formulated to provide localized pain relief. This product is presented in a 2.5 fl oz (74 mL) dosage form and features an odor-free composition. The formulation includes aloe, which may contribute to skin soothing properties. The product is designed with a no mess applicator for ease of use.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching. It provides symptomatic relief for pain-affected areas without causing irritation.

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 application is to the affected area no more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is properly prepared prior to administration.

For children under 2 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action.

Contraindications

Use of this product is contraindicated in the following situations:

• Application should not involve tight bandaging, as this may compromise circulation.

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

• The product should not be applied to wounds or damaged skin due to the risk of adverse reactions.

• Use in large quantities is contraindicated, particularly over raw surfaces or blistered areas, as this may lead to increased absorption and potential toxicity.

Warnings and Precautions

For external use only. It is imperative that the product is utilized strictly as directed to ensure safety and efficacy. Healthcare professionals should advise patients against tightly bandaging the area of application, as this may lead to adverse effects.

Contact with the eyes must be avoided to prevent irritation or injury. The product should not be applied to wounds or damaged skin, and caution is advised against using large quantities, especially over raw surfaces or blistered areas, to minimize the risk of complications.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware that it is for external use only. It is essential to use the product only as directed, avoiding tight bandaging and contact with the eyes. The product should not be applied to wounds or damaged skin, and caution should be exercised to avoid using large quantities, particularly over raw surfaces or blistered areas.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Additionally, it is crucial to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. 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 Pain Relief Roll-on (lidocaine 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

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. For children under 2 years of age, it is advised to consult a doctor prior to use.

Geriatric Use

There is no specific information available 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, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of Pain Relief Roll-On (lidocaine 4% liquid) during pregnancy. Consequently, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential risks versus benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the drug insert. Healthcare professionals should exercise caution when prescribing this medication to patients with renal impairment, as the absence of data may necessitate individualized assessment and monitoring based on clinical judgment.

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, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management procedures.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any overdosage incidents to facilitate effective treatment and minimize risks.

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 seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Patients should also be informed to stop using the product and seek medical advice if symptoms clear up and then recur within a few days.

When discussing the proper use of this product, healthcare providers should emphasize the importance of using it only as directed. Patients should be cautioned against bandaging tightly and advised to avoid contact with the eyes. Additionally, it is crucial to inform patients not to apply the product to wounds or damaged skin and to refrain from using it in large quantities, especially over raw surfaces or blistered areas.

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 direct light exposure, to ensure optimal stability and efficacy. Freezing the product is strictly prohibited, as it may compromise its quality. Once opened, the product should be discarded after use to prevent any potential degradation or contamination.

Additional Clinical Information

For patients aged 2 years and older, the medication should be applied to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)