Bioflexor

Description

BioFlexor Jar is a pharmaceutical product with an effective date of June 3, 2014. The product is visually represented by the image referenced as spl_image_bfjar.jpg. Further details regarding its chemical composition, dosage form, and inactive ingredients are not provided in the extracted facts.

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.

For adults and children aged 12 years and older, the drug should be applied to the affected area no more than 3 to 4 times daily.

Consultation with a physician is advised for children under 12 years of age, as well as for pregnant or nursing mothers, prior to use.

Dosage and Administration

BioFlexor gel should be applied to the affected area(s) up to 3 to 4 times daily, as needed. For optimal results, a sufficient amount of the gel should be applied at bedtime to promote restful sleep. Additionally, application in the morning is recommended to help loosen stiff muscles and joints, thereby reducing pain. Care should be taken to ensure that the gel is evenly distributed over the affected areas for effective relief.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

For external use only. Ingestion of this product is contraindicated; if accidentally swallowed, it is imperative to induce vomiting and seek immediate medical attention from a physician or poison control center.

Should irritation occur during use, the application of this product must be discontinued, and a physician should be consulted for further evaluation. This product is not intended for application on open sores, wounds, or any areas of irritated or broken skin, as such use may exacerbate the condition.

The concurrent use of this product with other topical formulations, including creams, gels, ointments, or heating devices, is not recommended due to the potential for adverse interactions. Additionally, contact with the eyes or mucous membranes must be strictly avoided to prevent irritation or injury.

Storage of this product should be in a cool, dry place, and it must be kept out of reach of children to prevent accidental poisoning.

BioFlexor gel is contraindicated in individuals with a known hypersensitivity to menthol. For pediatric patients under the age of 2, as well as for pregnant or nursing mothers, it is essential to consult a physician prior to use to ensure safety and appropriateness of treatment.

Side Effects

Patients using this product should be aware of several important safety warnings and potential adverse reactions. This product is intended for external use only and should not be ingested. In the event of accidental ingestion, it is crucial to induce vomiting and seek immediate medical attention by contacting a physician or poison control center.

If irritation develops during use, patients are advised to discontinue the product and consult a physician. The product should not be applied to open sores, wounds, or any irritated or broken skin. Additionally, it is important to avoid using this product in conjunction with other creams, gels, ointments, topical medications, heating pads, or any other heat-producing devices, as this may lead to adverse effects.

Patients should take care to avoid contact with the eyes or mucous membranes. The product should be stored in a cool, dry place and kept out of reach of children to prevent accidental poisoning. BioFlexor gel is contraindicated in individuals with a known hypersensitivity to menthol.

For specific populations, such as children under the age of 2, as well as pregnant or nursing mothers, it is recommended to consult a physician prior to use to ensure safety and appropriateness of the product.

Drug Interactions

Co-administration of this medication with other topical formulations, including creams, gels, ointments, or any other topical medications, is contraindicated. The use of heating pads or other heat-producing devices in conjunction with this medication is also not recommended. Such combinations may lead to enhanced local irritation or adverse effects due to increased absorption or altered pharmacodynamics.

It is advised to monitor the application site closely for any signs of irritation or adverse reactions if this medication is used in conjunction with other topical agents or heat sources.

Packaging & NDC

Below are the non-prescription pack sizes of Bioflexor (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age, as well as pregnant or nursing mothers, should consult a physician prior to use. The product is contraindicated in children under 12 years of age with arthritis-like conditions. For children under 12 years, it is advised to consult a doctor before application. In patients aged 12 years and older, the product may be applied to the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information available regarding the use of this medication, including dosage adjustments or safety concerns. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and nursing mothers are advised to consult a physician prior to use, particularly for children under 12 years of age. The potential risks and benefits should be carefully evaluated by healthcare professionals to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a physician before using this medication, particularly if they are breastfeeding children under 12 years of age. There is no specific data provided regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 event of an overdosage, it is crucial to note that the product is intended for external use only and should not be ingested. If accidental ingestion occurs, immediate action is required. The first step is to induce vomiting to minimize absorption of the substance. Following this, it is imperative to contact a physician or a poison control center without delay for further guidance and management.

Healthcare professionals should be aware of the potential risks associated with ingestion and ensure that patients are informed about the importance of adhering to the intended use of the product. Prompt medical intervention is essential in managing any complications that may arise from overdosage.

Nonclinical Toxicology

Consultation with a physician is advised for pregnant or nursing mothers due to potential teratogenic effects. There are no specific non-teratogenic effects or detailed nonclinical toxicology data available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of storing the medication in a secure location, ensuring that children cannot access it. This precaution helps to safeguard the health and safety of young individuals in the household.

Storage and Handling

The product is available in various package configurations, with specific NDC numbers assigned for identification. Currently, there are no specific storage instructions, temperature ranges, or special handling requirements provided for this product. It is recommended that healthcare professionals refer to the product's labeling for any additional information regarding supply and storage conditions.

Additional Clinical Information

Patients should apply the medication to the affected area no more than 3 to 4 times daily. It is for external use only and should not be applied to wounds or damaged skin. Clinicians should advise patients to avoid contact with the eyes or mucous membranes and to refrain from tightly bandaging the area.

Patients are encouraged to consult a doctor prior to use if there is redness over the affected area. They should discontinue use and seek medical advice if the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, or if excessive skin irritation occurs. The medication should be kept out of reach of children, and in the event of ingestion, medical assistance or contact with the Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Bioflexor, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)