Pain Relief Gel-Tube

Description

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

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints, including those related to arthritis, backache, strains, and sprains.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is to apply a thin film of the medication over the affected areas, not exceeding four applications per day. It is not necessary to massage the area after application.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing and administration guidance.

Contraindications

Application is contraindicated on wounds or damaged skin due to the potential for irritation and impaired healing. The use of this product in conjunction with other ointments, creams, sprays, or liniments is not recommended, as it may lead to adverse interactions or reduced efficacy.

Application to irritated skin is also contraindicated, as it may exacerbate the condition. Additionally, do not bandage the area or use with heating pads or devices, as this may increase the risk of adverse effects.

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

Warnings and Precautions

For external use only. This product is not intended for application on wounds or damaged skin. It is imperative to avoid using this product in conjunction with other ointments, creams, sprays, or liniments, as such combinations may lead to adverse effects. Application to irritated skin is also contraindicated.

Users should refrain from bandaging the treated area or using heating pads or devices simultaneously, as this may exacerbate irritation or lead to unwanted reactions. The product should be utilized strictly as directed, and care should be taken to avoid contact with the eyes or mucous membranes. Following application, hands should be washed thoroughly with cool water to prevent unintentional transfer of the product.

Storage conditions are crucial; the product should be kept in a cool, dry place, away from direct sunlight to maintain its efficacy.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Patients are instructed to discontinue use and consult a healthcare professional if they experience pain, swelling, or blistering at the application site, if their condition worsens, or if symptoms persist for more than seven days. Additionally, if symptoms resolve and then recur within a few days, medical advice should be sought.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if they experience pain, swelling, or blistering. Additionally, if the condition worsens, or if symptoms persist for more than 7 days, or clear up and then recur within a few days, medical advice should be sought.

Before using this product, patients with sensitive skin are advised to consult a healthcare provider to ensure safety and appropriateness of use.

Drug Interactions

Co-administration of this medication with other topical formulations, including ointments, creams, sprays, or liniments, is contraindicated. The use of multiple topical products may lead to altered absorption, increased risk of local irritation, or diminished therapeutic efficacy. It is advised to avoid concurrent use to ensure optimal treatment outcomes and minimize potential adverse effects.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. For adolescents and children aged 12 years and older, the recommended dosage is to apply a thin film over the affected areas no more than four times daily. Massage of the application site is not necessary.

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

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 associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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 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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, 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 limits the assessment of potential risks associated with the use of the compound in these contexts.

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 accidentally ingested. It is important to instruct patients not to apply the product to wounds or damaged skin, and to avoid using it in conjunction with other ointments, creams, sprays, or liniments. Patients should also be cautioned against applying the product to irritated skin.

Providers should emphasize that the product should not be bandaged or used with a heating pad or device. Patients must be informed to discontinue use and consult a healthcare professional if they experience pain, swelling, or blistering, if their condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Patients should be reminded to use the product only as directed and to avoid contact with eyes or mucous membranes. It is advisable for patients to wash their hands with cool water after using the product. Additionally, the product should be stored in a cool, dry place away from direct sunlight.

Finally, healthcare providers should encourage patients to consult a doctor before use if they have sensitive skin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dry place, away from excessive heat or open flame to maintain its integrity and efficacy. Proper handling should be observed to ensure the product remains within the recommended storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)