Invigo Flex Pain Relief Gel

Description

The product is identified by the SPL code 34089-3. No additional relevant details are available regarding its composition, formulation, or characteristics.

Uses and Indications

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

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

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 adverse effects and compromised healing. No other contraindications have been specified.

Warnings and Precautions

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

When using this product, it is imperative to avoid contact with the eyes. Additionally, users should refrain from applying tight bandages over the treated area to prevent complications.

In the event that a rash or irritation develops and persists, or if the condition worsens, it is advised to discontinue use and consult a healthcare professional. Users should also seek medical advice if symptoms do not improve within 7 days or if they resolve only to recur within a few days.

This product must be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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. It is contraindicated for application on damaged or broken skin. During use, patients are advised 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 should 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 or contact with a Poison Control Center is recommended.

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

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Invigo Flex Pain Relief Gel (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 available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is 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 lack of data 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 drug. 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 assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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 to instruct patients not to apply the product on damaged or broken skin to prevent further complications.

Patients should be informed to discontinue use and consult a doctor if they experience a rash or irritation that develops and persists. Additionally, they should be advised to stop using the product and seek medical advice if their condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

While using this product, patients must be cautioned to avoid contact with the eyes to prevent irritation or injury. Furthermore, they should be instructed not to bandage the area tightly when using the product, as this may lead to adverse effects.

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

For patients aged 2 years and older, the medication should be applied 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 doctor prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)