Op6 Menthol Warming Pain Cream

Description

The product is presented in a warming box, which is designed to maintain optimal temperature conditions for the contents. The packaging includes a warming label that provides essential information regarding the product's usage and handling. The overall design of the product label and box art is intended to convey professionalism and ensure clarity in communication.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains 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

Adults and children 12 years of age and older should apply the medication generously to the affected area. The product must be massaged into the painful area until it is thoroughly absorbed into the skin. This process may be repeated as necessary to achieve the desired effect.

The medication is intended for topical application only. Care should be taken to ensure that the product is massaged into the skin effectively to facilitate absorption.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid applying the product to wounds or damaged skin to prevent potential complications. It is crucial to avoid contact with the eyes, as this may lead to irritation or injury.

When using this product, it is important not to bandage the area tightly, as this could exacerbate any adverse effects or hinder proper healing. Patients should be 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 recur within a few days.

To ensure safety, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and should not be bandaged tightly during application. It is crucial to avoid contact with the eyes and to refrain from applying the product to wounds or damaged skin.

In the event that the condition worsens or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a healthcare professional. Additionally, the product should be kept out of reach of children. If the product is swallowed, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Op6 Menthol Warming Pain Cream (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older are indicated for use of the product. For this age group, the recommended application involves generously applying the product to the affected area and massaging it into the skin until fully absorbed. There are no specific dosage adjustments or additional cautions noted for this population.

Geriatric Use

There is no specific information 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

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use, as there may be potential risks to the fetus; however, specific studies or data regarding these risks are not provided in the prescribing information.

Healthcare professionals are advised to use this product with caution, emphasizing that it is for external use only. Any adverse reactions experienced by pregnant patients should be reported to a healthcare provider. No specific dosage modifications for pregnant individuals are mentioned in the prescribing information.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

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 available information 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 caution and consider the individual patient's liver status when prescribing this medication.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should be contacted without delay, or the Poison Control Center should be reached for guidance.

Symptoms of overdosage may vary depending on the specific substance involved. It is essential for healthcare providers to assess the patient thoroughly to identify any potential signs of toxicity.

Management of overdosage should be initiated promptly. This may include supportive care and symptomatic treatment as necessary. Healthcare professionals are advised to follow established protocols for the specific substance involved, which may include monitoring vital signs, administering activated charcoal if appropriate, and providing any necessary interventions based on the patient's clinical presentation.

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 keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control center immediately. This guidance is crucial for ensuring the safety and well-being of patients and their families.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to ensure optimal stability. Once opened, the product should be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Op6 Menthol Warming Pain Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)