Phoenix Kineticream Anti-Inflammatory and Pain Relief

Description

The product is identified by the SPL code 34089-3 and is packaged in a tube.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including simple backache, arthritis, bruises, sprains, cramps, and muscle strains.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

For adults and children aged 6 years and older, the product should be applied to dry and clean areas of the skin. Prior to physical activity, it is recommended to massage the product onto the muscles and joints until fully absorbed. Following physical activity, a generous application should be made to tired and affected areas.

The application may be repeated as necessary, with a maximum frequency of up to six times daily.

Contraindications

Use of this product is contraindicated in the following situations:

Contact with eyes and open wounds should be avoided due to the potential for irritation or adverse reactions. In the event of accidental ingestion, immediate medical assistance should be sought by contacting a local Poison Control Center or emergency room.

Warnings and Precautions

For external use only. This product should be utilized strictly as directed. It is advised that caregivers consult a physician before use in children under 6 years of age.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: the condition worsens, pain persists for more than 7 days, or if irritation develops.

It is imperative to avoid contact with the eyes and any open wounds to prevent adverse reactions. In the event of accidental ingestion, immediate medical assistance should be sought by contacting a local Poison Control Center or visiting the nearest emergency room.

Side Effects

Patients should be aware that the product is for external use only and should be used strictly as directed. It is advised that children under 6 years of age consult a doctor prior to use.

In the event that the condition worsens, pain persists for more than 7 days, or irritation develops, patients are instructed to stop use and seek medical advice. Additionally, contact with eyes and open wounds should be avoided. If the product is ingested, immediate medical assistance should be sought by contacting a local Poison Control Center or visiting an emergency room.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional before using the product.

It is crucial to keep this product out of reach of children to prevent accidental ingestion or misuse.

Drug Interactions

There are no known drug interactions associated with the use of this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Phoenix Kineticream Anti-Inflammatory and Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should use this medication only as directed. It is advised that caregivers consult a healthcare professional before administering the medication to this age group.

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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

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 drug 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 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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the product is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance without delay. This may involve contacting the local Poison Control Center or proceeding directly to the nearest emergency room.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of the symptoms presented.

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.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Patients should be instructed to stop using the medication and consult a doctor if their condition worsens, if pain persists for more than 7 days, or if any irritation develops.

It is important to inform patients to avoid contact with their eyes and any open wounds to prevent adverse effects. In the event of accidental ingestion, patients should seek medical help immediately or contact their local Poison Control Center or emergency room for assistance.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, away from direct light exposure. To maintain the quality of the product, it is essential to keep the tube tightly closed when not in use. Additionally, the product should be discarded after opening to prevent any potential degradation or contamination.

Additional Clinical Information

The product is administered topically, with specific instructions for both adults and children aged 6 years and older. Patients are advised to massage the product onto muscles and joints until fully absorbed into the skin before engaging in physical activity. After activity, it should be applied generously to tired and affected areas, ensuring that it is used on dry and clean skin. The application may be repeated as needed, with a maximum frequency of up to six times daily.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Phoenix Kineticream Anti-Inflammatory and Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)