Pain Relief Gel-Roll on

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 aches and pains associated with muscles and joints.

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 medication should be applied to 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 recommended to consult a physician prior to use to determine appropriate dosing and administration.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. The use of this product in conjunction with other ointments, creams, sprays, or liniments is not recommended, as it may lead to unpredictable interactions. Application to irritated skin or in cases where excessive irritation develops is contraindicated to prevent further skin damage. Bandaging the area after application is not advised, as it may alter the product's effectiveness. Additionally, the use of heating pads or devices in conjunction with this product is contraindicated due to the risk of increased irritation or adverse reactions.

Warnings and Precautions

For external use only. This product is flammable; therefore, it should be kept away from excessive heat or open flame to prevent any fire hazards.

Healthcare professionals should advise patients to seek medical assistance immediately if the product is swallowed, or to contact a Poison Control Center without delay.

Patients are instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then reoccur. Additionally, individuals with sensitive skin should consult a doctor prior to use to ensure safety and minimize the risk of adverse reactions.

Side Effects

Patients should be aware that the product is for external use only and is flammable; it should be kept away from excessive heat or open flame.

In clinical practice, patients are advised to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur. Additionally, individuals with sensitive skin should seek medical advice before using the product to avoid potential adverse reactions.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of heating pads or devices in conjunction with this medication is also not recommended, as it may lead to adverse effects.

There are no specific interactions identified between this medication and laboratory tests. Therefore, no adjustments or special monitoring related to laboratory tests are necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Relief Gel-Roll on (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 adults aged 12 years and older, the recommended application is to rub a thin film over the affected areas no more than four times daily; massage is not necessary.

It is important to keep this product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center.

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 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 potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

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

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the potential risks and benefits.

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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, 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 compound in these areas.

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. Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur.

It is important to inform patients to avoid contact with their eyes or mucous membranes and to refrain from applying the product to wounds or damaged skin. Patients should be cautioned against using the product in conjunction with other ointments, creams, sprays, or liniments, as well as on irritated skin or if excessive irritation develops. Additionally, patients should be advised not to bandage the area after application.

Healthcare providers should emphasize the importance of washing hands with cool water after using the product. Patients should also be informed not to use the product with heating pads or devices. Finally, it is recommended that patients store the product in a cool, dry place to maintain its efficacy.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It is essential to store the product in a cool, dry place to maintain its integrity and effectiveness.

Due to its flammable nature, it must be kept away from excessive heat sources and open flames to prevent any hazardous situations. Proper storage conditions are crucial for ensuring the safety and efficacy of the product.

Additional Clinical Information

For patients aged 12 years and older, the recommended administration involves applying a thin film of the product over the affected areas up to four times daily, without the need for massage. For children under 12 years of age, it is advised to consult a physician prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)