Abejas Y Viboras Brand Roll-on

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The medication should be used only as directed. For adults and children over 12 years of age, a thin film should be applied to the affected areas, not exceeding four times daily. It is not necessary to massage the area after application. The use of this medication is not recommended for children 12 years of age or younger.

Contraindications

Use is contraindicated in children due to the risk of accidental poisoning. It is essential to keep the product out of reach of children. In the event of ingestion, induce vomiting and seek immediate medical attention or contact a Poison Control Center.

Warnings and Precautions

For external use only. This product should not be applied to wounds or damaged skin, nor should it be used in conjunction with a heating pad. It is contraindicated for use on children aged 12 years and under, over extensive areas of the body, on irritated skin, or with a bandage. Additionally, it should not be combined with other ointments, creams, sprays, or liniments. Prior to use, individuals should consult a healthcare professional if there is redness present over the affected area.

When utilizing this product, it is essential to adhere to general precautions. Users should wash their hands thoroughly with cool water after application and avoid contact with the eyes or mucous membranes. Bandaging the area of application is not recommended.

Patients are advised to discontinue use and consult a healthcare provider if the condition worsens or if symptoms persist for more than 7 days. If symptoms resolve and then recur within a few days, or if excessive skin irritation occurs, medical advice should be sought.

To prevent accidental poisoning, this product must be kept out of reach of children. In the event of ingestion, it is critical to induce vomiting and seek immediate medical assistance by contacting a physician or a Poison Control Center.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is for external use only and should not be applied to wounds or damaged skin. It is contraindicated for use with heating pads, on children aged 12 years and under, over extensive areas of the body, on irritated skin, or in conjunction with bandages or other ointments, creams, sprays, or liniments. Patients are advised to consult a doctor before use if there is redness over the affected area.

During the use of this product, it is recommended that patients wash their hands with cool water after application and avoid contact with eyes or mucous membranes. Bandaging the area of application is also discouraged.

Patients should discontinue use and seek medical advice if any of the following occur: the condition worsens or symptoms persist for more than 7 days; symptoms resolve and then recur within a few days; or if excessive skin irritation develops.

Drug Interactions

The use of this medication is contraindicated with other topical formulations, including ointments, creams, sprays, or liniments. Co-administration may lead to altered efficacy or increased risk of adverse effects due to overlapping mechanisms of action or compounded irritative effects.

There are no specific interactions identified with laboratory tests associated with this medication. Therefore, no adjustments or special monitoring related to laboratory tests are necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Abejas Y Viboras Brand Roll-on (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age and under should not be administered this medication. There are no established safety or efficacy profiles for this age group, and its use is contraindicated in children 12 years or younger.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. 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 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 on 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 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 the management of the overdose. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose effectively.

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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental poisoning. It is crucial to emphasize the importance of safeguarding the medication, as children may be particularly vulnerable to its effects.

In the event that the medication is swallowed, healthcare providers should instruct patients to induce vomiting immediately and seek medical attention by calling a physician or contacting a Poison Control Center without delay. This prompt action is essential to mitigate potential harm.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to ensure optimal stability. Once opened, the product should be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

Patients aged 12 years and older are advised to apply a thin film of the product to the affected areas up to four times daily, without the need for massage. The product is not recommended for children under 12 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before using the product. It is important to keep the product out of reach of children to prevent accidental poisoning. In the event of ingestion, patients should induce vomiting and seek immediate medical attention or contact a Poison Control Center.

Drug Information (PDF)

This file contains official product information for Abejas Y Viboras Brand Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)