Inspiration Academy Menthol Cooling Roll on

Description

No specific description details related to SPL code 34089-3 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, joint discomfort, strains, sprains, and arthritis.

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 exacerbating the condition or causing further harm.

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

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 seek emergency medical help or contact a Poison Control Center immediately.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur 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 Inspiration Academy Menthol Cooling 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

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any recommendations or considerations related to age. Furthermore, there are no dosage adjustments, safety concerns, or special precautions indicated for geriatric patients.

Healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, considering the absence of data specific to this population. Monitoring for efficacy and safety is advised, as individual responses may vary.

Pregnancy

There is no specific information regarding the use of this product during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or provide any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

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 data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous monitoring and supportive care should be maintained until the patient is stabilized and any potential complications are addressed.

Documentation of the incident, including the substance involved, estimated dose, time of ingestion, and any interventions performed, is vital for ongoing patient management and future reference.

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 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 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 recur within a few days.

When using this product, healthcare providers should emphasize the following precautions: patients should not bandage the area tightly, avoid contact with the eyes, and refrain from applying the product to wounds or damaged skin. Additionally, patients should be cautioned against using this 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 should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. Additionally, the product must be protected from light exposure to prevent degradation.

To ensure optimal preservation, the container should be kept tightly closed when not in use. It is important to note that the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)