Berri-Freez

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the topical treatment of affected areas in adults and children aged 2 years and older. For children under 2 years of age, consultation with a healthcare professional is recommended prior to use.

The drug should be applied to clean and dry skin, not exceeding 3 to 4 applications per day. It may be used in conjunction with wet or dry bandages and ice packs as needed.

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

Dosage and Administration

The medication should be applied to the affected area no more than 3 to 4 times daily. Healthcare professionals are advised to instruct patients on the importance of adhering to this frequency to optimize therapeutic outcomes while minimizing the risk of potential side effects. Care should be taken to ensure that the application is performed gently and uniformly across the affected area.

Contraindications

Use is contraindicated in situations where the product may be ingested by children. In the event of accidental ingestion, immediate medical attention or contact with a poison control center is required.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. Healthcare professionals should advise patients to avoid contact with the eyes and to refrain from applying a tight bandage over the treated area. It is imperative that the product is not applied to wounds or damaged skin, as this may lead to adverse effects.

Patients should be cautioned against using this product in conjunction with a heating pad, as this may exacerbate potential side effects. In the event that the condition worsens or if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days, patients are advised to discontinue use and consult a healthcare provider.

Additionally, this product should be kept out of reach of children. In cases of accidental ingestion, immediate medical attention should be sought, or the poison control center should be contacted without delay.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is intended for external use only and should be used strictly as directed. Care should be taken to avoid contact with the eyes, as this may lead to irritation or other adverse effects. Additionally, patients are advised not to bandage the area tightly, as this could exacerbate potential reactions.

The product should not be applied to wounds or damaged skin, as this may increase the risk of adverse reactions. Furthermore, it is important to avoid using the product in conjunction with a heating pad, as this may lead to increased irritation or other complications.

Patients are instructed to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. These precautions are essential to ensure the safe and effective use of the product.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may use the medication as directed. For children under 2 years of age, consultation with a healthcare professional is advised prior to use. The recommended application frequency for pediatric patients is no more than 3 to 4 times daily to the affected area.

Geriatric Use

There is no specific information regarding the use of Berri-Freez menthol gel in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when administering this product to elderly patients, as the absence of data necessitates careful monitoring for any potential adverse effects or unique responses in this population. It is advisable to consider individual patient factors and clinical judgment when treating geriatric patients with this product.

Pregnancy

There are no specific warnings or precautions regarding the use of Berri-Freez menthol gel during pregnancy. The available information does not indicate whether the product is contraindicated in pregnant patients or if there are any associated risks to the fetus. Additionally, no dosage modifications or special precautions for individuals who are pregnant are provided. Healthcare professionals should consider the absence of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

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 implement supportive care measures, 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 effectively.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for appropriate treatment 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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are provided in the insert for Berri-Freez menthol gel.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. Instruct patients that if the medication is swallowed, they should seek medical attention or contact the poison control center immediately. It is important for patients to understand the potential risks associated with accidental ingestion, particularly in young children, and to take appropriate precautions to prevent such incidents.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at room temperature, within the range of 15° to 30°C (59° to 86°F). Care should be taken to keep the product away from heat sources and open flames to ensure its integrity and safety during storage.

Additional Clinical Information

The medication is administered topically, with application to the affected area recommended no more than 3 to 4 times daily. Clinicians should advise patients to keep the product out of reach of children, and in the event of ingestion, to seek medical attention or contact a poison control center immediately. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)