Good Neighbor Roll-on Menthol Pain Relief Gel

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, simple backache, muscle strains, sprains, and bruises.

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

Dosage and Administration

For adults and children over 12 years of age, a thin layer of the medication should be applied to the affected area. The application should be followed by 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 3 to 4 applications per day. In the event that the medication comes into contact with the hands, it is advised to wash the hands with soap and water immediately.

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

Contraindications

The product should not be used in the following situations:

Tight bandaging or the application of local heat, such as heating pads or medicated patches, to the area of use is contraindicated due to the potential for increased irritation or adverse effects.

Application to wounds or damaged, broken, or irritated skin is contraindicated to prevent exacerbation of the condition and to ensure proper healing.

Exposure of the treated area to heat or direct sunlight should be avoided, as this may lead to increased sensitivity or adverse reactions.

Application into skin folds is not recommended, as this may result in improper absorption or increased risk of irritation.

Warnings and Precautions

For external use only, this product has been associated with rare cases of serious burns. Healthcare professionals should advise patients against bandaging the treated area tightly or applying local heat, such as heating pads or medicated patches, to the site of application. It is crucial to avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds or any damaged, broken, or irritated skin.

Patients may experience a transient burning sensation upon application, which typically resolves within several days. However, if a severe burning sensation occurs, the patient should discontinue use immediately. Additionally, the treated area should not be exposed to heat or direct sunlight, and care should be taken to avoid application in skin folds.

Patients are instructed to stop use and consult a healthcare professional if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, or recurrence of symptoms after initial improvement. Signs of skin injury, such as pain, swelling, or blistering at the application site, also warrant immediate medical consultation.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact the Poison Control Center at 1-800-222-1222 without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. While the product is generally safe, rare cases of serious burns have been reported with similar products. Upon application, a transient burning sensation may occur; this sensation typically resolves within several days. However, if a severe burning sensation is experienced, patients are advised to discontinue use immediately.

Patients should stop using the product and consult a healthcare professional if any of the following occur: the condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should seek medical advice if they experience signs of skin injury, such as pain, swelling, or blistering at the site of application.

Drug Interactions

No drug interactions have been reported for this medication. Additionally, there are no known interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Good Neighbor Roll-on Menthol Pain Relief Gel (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. For patients over 12 years, including adults, a thin layer of the product should be applied to the affected area.

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 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. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully known. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks before initiating treatment.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 text 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 lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 assistance is crucial. If the substance is swallowed, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact the Poison Control Center at 1-800-222-1222 for further guidance and support.

Prompt intervention is essential to manage potential symptoms associated with overdosage effectively. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management procedures based on the severity of the symptoms presented.

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 these contexts.

Postmarketing Experience

Rare cases of serious burns have been reported in association with products of this type. These events were identified through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact the Poison Control Center at 1-800-222-1222 if the product is swallowed.

Patients should be instructed to stop using the product and consult a doctor if any of the following occur: the condition worsens, redness develops, irritation occurs, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should seek medical advice if they experience signs of skin injury, such as pain, swelling, or blistering at the site of application.

When using this product, patients must be reminded to use it only as directed and to read and follow all directions and warnings provided on the carton. It is important to inform patients that rare cases of serious burns have been reported with similar products. They should be cautioned against bandaging the area tightly, applying local heat (such as heating pads), or using a medicated patch on the treated area.

Patients should also be advised to avoid contact with eyes and mucous membranes, and not to apply the product to wounds or damaged, broken, or irritated skin. A transient burning sensation may occur upon application, but this typically resolves within several days. If a severe burning sensation occurs, patients should discontinue use immediately. Furthermore, patients should be instructed to avoid exposing the treated area to heat or direct sunlight and to refrain from applying the product into skin folds.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)