Berri-Freez

Description

The product is identified by the SPL Code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various musculoskeletal conditions. Specifically, it is effective for alleviating discomfort related to back, shoulder, and neck strains, as well as joint discomfort in the ankle, knee, hip, and elbow. Additionally, it provides relief for muscle sprains and strains, and is indicated for use in patients experiencing arthritis.

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

Dosage and Administration

Adults and children 12 years of age and older are advised to administer 1 to 2 sprays to the affected areas as needed. This can be done up to a maximum of 4 times daily. It is important to note that massage of the sprayed area is not necessary for effective use.

Contraindications

There are no contraindications listed for this product.

However, it is advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur.

Warnings and Precautions

The product is flammable; therefore, it is imperative to keep it away from excessive heat or open flames. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Healthcare professionals should advise patients to avoid contact with the eyes and mucous membranes. The product must not be applied to wounds or damaged skin, nor should it be used on irritated skin or if excessive irritation develops. Additionally, it is important to refrain from bandaging the area after application.

Patients should wash their hands thoroughly with cool water following use. The product is intended for external use only and must be kept out of reach of children.

If the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur, patients should be instructed to stop use and consult a doctor.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is flammable; therefore, it should be kept away from excessive heat or open flame. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

When using this product, patients are instructed to avoid contact with the eyes or mucous membranes. It should not be applied to wounds, damaged skin, or irritated skin, especially if excessive irritation develops. Additionally, the product should not be bandaged, and hands should be washed with cool water after use. It is also advised not to use the product in conjunction with a heating pad or any heating device.

Patients are advised to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur.

Drug Interactions

The use of this medication is contraindicated with heating pads or devices, as this may lead to adverse effects. It is essential to avoid concurrent use to ensure patient safety and the efficacy of the treatment.

Regarding laboratory test interactions, there are no specific interactions identified. Therefore, routine laboratory tests can be performed without concern for interference from this medication.

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 should be kept out of reach of children. For adolescents aged 12 years and older, the recommended dosage is 1-2 sprays applied to the affected areas as needed, not to exceed 4 times daily. Massage of the area is not necessary.

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. 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 healthcare professional prior to using this medication. There is currently no available data regarding 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 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 and consider the overall clinical context when prescribing this medication to patients with hepatic impairment, as the lack of data may necessitate individualized assessment and monitoring.

Overdosage

In the event of an overdosage, it is imperative that immediate medical assistance is sought. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay if the substance is accidentally ingested.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by medical personnel is essential.

Management procedures will typically involve supportive care and symptomatic treatment, tailored to the individual case. Continuous monitoring of the patient’s condition is recommended to address any complications that may arise during the course of treatment.

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 that the product is intended for external use only and must be kept out of reach of children to prevent accidental ingestion or misuse.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if the symptoms clear up and then reoccur. This guidance is essential to ensure patient safety and to facilitate appropriate medical intervention if necessary.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ensuring that it is kept away from excessive heat and open flames. Due to its flammable nature, it is imperative to handle the product with care to avoid any ignition sources. Proper storage and handling practices are essential to maintain the integrity and safety of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to administer the product topically, applying 1-2 sprays to the affected areas as needed, not exceeding 4 times daily. Massage of the area is not required.

Clinicians should counsel patients on the following precautions: the product is for external use only and should be kept out of reach of children. It is flammable, necessitating avoidance of excessive heat or open flames. In the event of accidental ingestion, medical assistance or contact with a Poison Control Center is imperative. Patients should avoid contact with eyes and mucous membranes, and should not apply the product to wounds, damaged, or irritated skin. Bandaging the area is not recommended, and hands should be washed with cool water after use. Patients should discontinue use and consult a doctor if the condition worsens, symptoms persist beyond 7 days, or if symptoms clear up and then reoccur. Pregnant or breastfeeding individuals should seek advice from a healthcare professional prior to use.

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)