Op 6 Menthol Warming Roll on

Description

The OP6 Warming Roll is presented in a labeled box designed for professional use. The packaging includes the OP6 Warming Roll label, which provides essential information regarding the product. The outer box is specifically designed to contain the OP6 Warming Roll, ensuring proper identification and storage.

Uses and Indications

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

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 application is to the affected area no more than 10 times per day, as needed for pain relief. It is essential to ensure that the application does not exceed this frequency to avoid potential adverse effects.

For children under 12 years of age, the product is not recommended for use. Healthcare professionals should advise caregivers to consult a doctor for appropriate alternatives or guidance regarding pain management in this age group.

Contraindications

Use of this product is contraindicated in the following situations:

• Tight bandaging should be avoided to prevent compromised circulation.

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

• Application to wounds or damaged skin is contraindicated due to the risk of adverse effects.

• Concurrent use with heating pads or other heating devices is not recommended, as it may lead to increased absorption and potential toxicity.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of reach of children to prevent accidental ingestion. In the event of swallowing, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

In cases of accidental ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Op 6 Menthol Warming Roll on (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a doctor. For adolescents aged 12 years and older, the recommended application is to the affected area no more than 10 times a day as needed for pain.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the variability in pharmacokinetics and pharmacodynamics that may occur with aging. Additionally, consideration should be given to the presence of comorbidities and the potential for polypharmacy in this population, which may necessitate dosage adjustments or increased monitoring.

Pregnancy

There is currently no information available regarding the use of OP 6 Menthol Warming Roll On during pregnancy. This includes a lack of data on safety concerns, dosage modifications, or any special precautions that should be taken when considering the use of this product in pregnant patients. Healthcare professionals should exercise caution and consider the absence of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by 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

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

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

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert for OP 6 MENTHOL WARMING ROLL ON.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed 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 recur within a few days.

While using this product, patients should be cautioned against bandaging tightly and should avoid contact with the eyes. It is important to instruct patients not to apply the product to wounds or damaged skin. Additionally, patients should be advised not to use the product in conjunction with heating pads or other heating devices to prevent adverse effects.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy.

To ensure optimal preservation, the product must be protected from light exposure. Additionally, it is crucial to keep the container tightly closed when not in use to prevent contamination and degradation. Once opened, the product should be discarded after use to ensure safety and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Op 6 Menthol Warming Roll on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)