Inspiration Academy Menthol Cooling Pain Cream

Description

IA Cream is a topical formulation containing the active ingredient Ivermectin. The cream is presented in a white to off-white color and is supplied in a 30 g tube. Inactive ingredients include water, glycerin, propylene glycol, cetyl alcohol, stearyl alcohol, polysorbate 60, sorbitan stearate, and methylparaben.

Uses and Indications

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

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 product generously to the affected area. The application should be followed by a gentle massage into the skin until the formulation is thoroughly absorbed. This process may be repeated as necessary, depending on the individual's needs and the severity of the condition.

The product is intended for topical use only, and it is important to ensure that the application is directed specifically to the areas of discomfort. Care should be taken to avoid contact with eyes and mucous membranes.

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.

• The use of heating pads or other heating devices in conjunction with this product is not recommended, as it may lead to increased irritation or adverse effects.

Warnings and Precautions

For external use only. It is imperative to keep this product 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 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. Monitoring for these symptoms is essential to ensure patient safety and effective management of the condition.

Side Effects

For external use only. Patients should be advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than seven 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 Inspiration Academy Menthol Cooling Pain Cream (menthol 5 percent). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a poison control center is advised.

For dosing, the product is indicated for use in adults and children aged 12 years and older, who should apply the medication generously to the affected area. There are no specific dosage recommendations provided for children under 12 years of age.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

Pregnancy

The safety of this product during pregnancy has not been established. Caution is advised as the effects on the fetus are unknown. Pregnant patients or women of childbearing potential should consult a healthcare provider before use, especially if they are planning to become pregnant.

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

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 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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 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 seven days, or if symptoms clear up and then recur within a few days.

When using this product, patients should be cautioned against bandaging tightly, as this may lead to complications. They should also be advised to avoid contact with the eyes and not to apply the product to wounds or damaged skin. Additionally, patients should refrain from using heating pads or other heating devices in conjunction with this product to ensure safety and efficacy.

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 at room temperature to maintain its efficacy.

To ensure safety, the product should be kept out of reach of children. When applying, care should be taken to avoid bandaging tightly, as this may lead to complications. Additionally, contact with the eyes must be avoided, and the product should not be applied to wounds or damaged skin.

It is also important to refrain from using heating pads or other heating devices in conjunction with the product, as this may alter its intended use or effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)