Biotemper

Description

Bio-Rollon1 is a pharmaceutical formulation designed for topical application. It is presented in a roll-on dosage form, facilitating ease of use and targeted delivery. The product's specific chemical composition and molecular weight are proprietary, ensuring its unique therapeutic profile. The formulation is characterized by its clear appearance, which aids in patient compliance and application visibility. Inactive ingredients are included to enhance the stability and efficacy of the active components, although specific details regarding these excipients are not disclosed.

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, 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 exceeding four times daily. It is important to apply the product in one direction only, avoiding a circular motion. For children under 2 years of age, consultation with a physician is advised prior to use.

Prior to application, the product should be shaken well to ensure proper mixing. Massage of the area is not necessary following application.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if the product is swallowed, medical assistance should be sought immediately or contact a Poison Control Center.

Warnings and Precautions

This product is intended for external use only. It is important to note that the formulation is flammable; therefore, it should be kept away from fire or flame to prevent any risk of ignition.

When utilizing this product, healthcare professionals should advise patients to avoid contact with the eyes and mucous membranes. Additionally, it is crucial not to bandage the area tightly, and the product should not be applied to wounds, damaged skin, or areas of irritation.

Patients should be instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days.

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

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 without delay.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and is flammable; therefore, it should be kept away from fire or flame. During use, patients are advised to avoid contact with the eyes or mucous membranes. Additionally, it is important not to bandage the area tightly or apply the product to wounds, damaged skin, or irritated skin.

In the event that the condition worsens, symptoms persist for more than 7 days, or if the condition clears up and then recurs within a few days, patients should discontinue use and consult a healthcare professional. Furthermore, pregnant or breastfeeding individuals are encouraged to seek advice from a health professional prior to using this product.

Drug Interactions

There are currently no specific drug interactions or drug and laboratory test interactions identified for the medication. As such, no dosage adjustments or monitoring recommendations are necessary at this time. Healthcare professionals should continue to assess the patient's overall medication regimen and clinical status to ensure safe and effective use of the medication.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area up to four times daily, ensuring application is in one direction and not circular. For children under 2 years of age, it is advised to consult a physician prior to use.

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 potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

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 potential effects in nonclinical settings.

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. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing potential risks associated with accidental exposure.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It is essential to store the product in a cool and dry place, ensuring that the lid is closed tightly to prevent contamination and maintain efficacy. Proper storage conditions are critical for the product's stability and longevity.

Additional Clinical Information

For patients aged 2 years and older, the product should be applied to the affected area no more than four times daily, ensuring application is in one direction rather than circular. For children under 2 years of age, consultation with a physician is advised. It is not necessary to massage the area after application, and the product should be shaken well before use.

Drug Information (PDF)

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

View product document (PDF)