Gaspari Ageless Pain Relief Cream

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available text.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints. It is specifically indicated for conditions such as simple backache, arthritis, strains, bruises, and sprains.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a healthcare professional prior to use to determine the appropriate course of action.

Contraindications

The use of this product is contraindicated in patients with damaged or broken skin due to the potential for adverse effects and compromised healing.

Warnings and Precautions

For external use only. This product is contraindicated for application on damaged or broken skin.

When utilizing this product, it is imperative to avoid contact with the eyes. Additionally, it is advised not to apply a tight bandage over the treated area to prevent complications.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if a rash or irritation develops and persists, if the condition worsens, or if symptoms do not improve within 7 days. Patients should also be advised to consult a physician if symptoms resolve and then recur within a few days.

This product should be kept out of reach of children. In the event of ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made. Pregnant or breastfeeding individuals are encouraged to consult a healthcare professional prior to use.

Side Effects

Patients using this product should be aware that it is intended for external use only and should not be applied to damaged or broken skin. During use, it is important to avoid contact with the eyes and to refrain from tightly bandaging the area of application.

In the event that a rash or irritation develops and persists, or if the condition worsens, patients are advised to discontinue use and consult a healthcare professional. Additionally, if symptoms do not improve within 7 days or if they resolve and then recur within a few days, medical advice should be sought.

This product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be obtained or the local Poison Control Center contacted. Pregnant or breastfeeding individuals are encouraged to consult a healthcare professional prior to use.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

Geriatric Use

There is no specific information regarding the use of GASPARI Ageless Pain Relief Cream in geriatric patients. The prescribing information does not provide details on dosage adjustments, safety concerns, or special precautions that may be necessary for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this product to geriatric patients, as the absence of specific data necessitates careful monitoring and assessment of treatment efficacy and safety in 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 considered, as the effects on fetal outcomes and breastfeeding infants are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider to ensure safe use during pregnancy and lactation.

Lactation

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

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential.

Management procedures should include monitoring vital signs and providing supportive care as needed. In cases where the specific substance is known, appropriate antidotes or treatments should be administered as per established protocols.

It is essential for healthcare providers to remain vigilant and act swiftly to mitigate the 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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

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. It is important for patients who are pregnant or breastfeeding to consult a health professional prior to use.

Patients should be cautioned to avoid contact with the eyes, as this may lead to irritation or other adverse effects. Additionally, they should be instructed not to bandage the area tightly, as this could exacerbate any potential issues.

Healthcare providers should inform patients to discontinue use and consult a doctor if a rash or irritation develops and persists, if the condition worsens, or if symptoms last longer than 7 days or reappear shortly after clearing up. Furthermore, patients should be advised against using the product on damaged or broken skin to prevent complications.

Storage and Handling

The product is supplied in a container designed to safeguard its integrity. It is essential to protect the product from excessive heat and direct sunlight to maintain its efficacy and safety. Proper storage conditions should be observed to ensure optimal performance.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years, consultation with a doctor is advised prior to use. Clinicians should counsel patients to avoid contact with the eyes and to discontinue use if a rash or irritation develops, if the condition worsens, or if symptoms persist beyond 7 days or recur shortly after resolution. Additionally, patients who are pregnant or breastfeeding should seek advice from a healthcare professional before using the product.

Drug Information (PDF)

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

View product document (PDF)