Paractin Quantumactiv Pain Relief Cream

Description

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

Uses and Indications

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

Limitations of Use: 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 frequency is to apply the medication to the affected area no more than 3 to 4 times daily.

For children under 2 years of age, it is advised to consult a healthcare professional prior to use.

Contraindications

Use is contraindicated on damaged or broken skin due to the potential for irritation and impaired healing. Contact with the eyes should be avoided to prevent adverse effects. Additionally, do not apply tightly bandaged dressings, as this may compromise circulation and lead to further complications.

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 should not be applied with tight bandaging, as this may exacerbate potential adverse effects.

Healthcare professionals should advise 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 after 7 days. Should symptoms resolve and then recur within a few days, medical consultation is also recommended.

This product must 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 is advised.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional prior to use to ensure safety for both the mother and child.

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 application, it is important to avoid contact with the eyes and to refrain from tightly bandaging the area.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if a rash or irritation develops and persists, if the condition worsens, or if symptoms last longer than 7 days or resolve only to recur within a few days.

Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional prior to use to ensure safety.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. 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 Paractin Quantumactiv 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 medication may be applied to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information regarding the use of PARACTIN QuantumActiv Pain Relief Cream in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when considering this product for elderly patients, as the absence of data necessitates careful monitoring and assessment of individual patient needs and responses. It is advisable to evaluate the overall health status and any concurrent medications of geriatric patients prior to recommending this treatment.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to ensure appropriate management during pregnancy.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human 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 lack of data may impact the drug's efficacy and safety profile in this population. Regular monitoring of renal function is advisable to ensure patient safety.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

In all cases of suspected overdosage, the involvement of poison control and emergency medical services is recommended to ensure optimal patient care and safety.

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 question.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed not to use the product on damaged or broken skin. They should be informed to stop using the product and consult a doctor if a rash or irritation develops and persists, if the condition worsens, or if symptoms do not improve after 7 days or if they clear up and then recur within a few days.

While using this product, patients should be cautioned to avoid contact with the eyes and to refrain from applying a tight bandage over the area of application.

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

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is recommended that a clinician be consulted prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)