Pain Relief Sleeve

Description

NDC 64092-506-1 (ITEM 863906) and NDC 64092-520-1 (ITEM 863920) represent Extra Strength Pain Relief Sleeves manufactured by GLS under the Personal Care Solutions brand. Each sleeve contains 16% menthol and is designed for targeted pain relief.

The Medium Pain Relief Sleeve is suitable for knees and small to medium ankles and elbows, expanding to fit circumferences ranging from 5 inches to 12 inches (12.5 cm to 30.5 cm). The sleeve is medicated and features a breathable design, incorporating a pain-relieving lotion.

The Large Pain Relief Sleeve is intended for knees and large ankles and elbows, accommodating circumferences from 8 inches to 24 inches (20 cm to 61 cm).

The XLarge Pain Relief Sleeve is also designed for knees, large ankles, and elbows, with an expansion range of 12 inches to 28 inches (30.5 cm to 70 cm). Each product contains one sleeve patch, providing a convenient application method for localized pain relief.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as arthritis, strains, bruises, and sprains.

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

Dosage and Administration

Adults and children over 12 years of age should apply the sleeve by pulling it onto the knee, large ankle, or elbow until the colored section is positioned directly over the affected area. The sleeve should feel snug against the skin, ensuring it is not overly tight.

The application is intended for use on the knee, large ankle, or elbow as needed.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if redness or irritation occurs. Additionally, if the condition worsens or symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, medical advice should be sought.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes during application. It is crucial to refrain from applying the product to wounds or damaged skin to prevent adverse reactions. Additionally, patients should be instructed not to bandage the area tightly after application and to avoid using the product in conjunction with heating pads, as this may increase the risk of skin irritation or other complications.

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

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: the presence of redness or the development of irritation, worsening of the condition, or if symptoms persist for more than seven days. Furthermore, if symptoms resolve and then recur within a few days, medical advice should be sought. Regular monitoring of the patient's response to treatment is recommended to ensure safety and efficacy.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only. Users are advised to avoid contact with the eyes and to refrain from applying the product to wounds or damaged skin. Additionally, it is recommended not to bandage the area tightly or use the product in conjunction with a heating pad.

In the event of adverse reactions, patients should discontinue use and consult a healthcare professional if any of the following occur: redness is present, irritation develops, the condition worsens, or if symptoms persist for more than 7 days. Patients should also seek medical advice if symptoms clear up and then recur within a few days.

Drug Interactions

The use of this medication is contraindicated with heating pads due to the potential for increased risk of adverse effects. It is advised that patients avoid the concurrent use of heating pads while on this medication to prevent any complications.

There are no specific laboratory test interactions associated with this medication. Therefore, routine laboratory monitoring is not required for interactions with laboratory tests.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Relief Sleeve (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 prior to use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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

Safety during pregnancy has not been established for this medication. It is contraindicated for use during pregnancy, as potential risks to the fetus are not clearly defined. Healthcare providers should be consulted for advice regarding the use of this medication in pregnant patients or women of childbearing potential.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific guidelines or recommendations are not provided.

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 consider 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 initiate supportive care and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, healthcare professionals should consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management 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 limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

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 for patients to be aware of the potential risks associated with accidental ingestion.

Additionally, healthcare providers should instruct patients to discontinue use and consult a doctor if they experience any redness or irritation. Patients should be informed to monitor their condition closely; if symptoms worsen or persist for more than 7 days, or if symptoms resolve and then recur within a few days, they should seek medical advice promptly.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is not exposed to freezing conditions. Additionally, the product must be protected from light to maintain its integrity. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically and is intended for external use only. Clinicians should advise patients to avoid contact with the eyes and not to apply the product to wounds or damaged skin. It is important to instruct patients not to bandage the area tightly or use it in conjunction with a heating pad.

Patients should be counseled to discontinue use and consult a doctor if they experience redness, irritation, worsening of the condition, or if symptoms persist for more than 7 days or recur shortly after resolution. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

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

View product document (PDF)