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Berri-Freez Plus

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This product has been discontinued

Active ingredients
  • Camphor (synthetic) 0.226 g/113 g
  • Menthol 4.52 g/113 g
  • Methyl Salicylate 9.04 g/113 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
August 23, 2012
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Camphor (synthetic) 0.226 g/113 g
  • Menthol 4.52 g/113 g
  • Methyl Salicylate 9.04 g/113 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
August 23, 2012
Manufacturer
Geritrex LLC
Registration number
part348
NDC root
54162-008
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Berri Freez Plus is a topical treatment designed for adults and children aged 2 years and older to help cleanse and dry the skin. It is applied directly to the affected area and can be used up to 3 to 4 times daily. This product may also be used in combination with wet or dry bandages and ice packs to enhance its effectiveness. If you have a child under 2 years of age, it's important to consult a doctor before use.

Uses

If you or your child is 2 years of age or older and dealing with a skin issue, this treatment can help. It's important to first cleanse and dry the affected area before applying the product. You should apply it no more than 3 to 4 times a day for the best results.

For added comfort, you can use this treatment with either wet or dry bandages, and it can be combined with ice packs to help soothe the area. If your child is under 2 years old, be sure to consult a doctor before use.

Dosage and Administration

You should apply the medication to the affected area no more than 3 to 4 times each day. Make sure to follow this guideline to ensure the best results and avoid any potential side effects. If you have any questions about how to use the medication or how often to apply it, don’t hesitate to reach out to your healthcare provider for more information.

What to Avoid

It's important to keep this product out of reach of children to ensure their safety. If a child accidentally swallows it, seek medical help or contact the Poison Control Center right away.

You should also stop using the product and consult a doctor if your condition worsens, or if your symptoms last longer than 7 days or return after clearing up. Always prioritize your health and safety when using any medication.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it and consult a doctor if your condition worsens, if symptoms last longer than 7 days, or if they improve and then return shortly after.

Remember, this product is for external use only. Avoid contact with your eyes, and do not apply it to wounds or damaged skin. It's also advised not to use it with a heating pad or to bandage the area tightly. Always follow the directions provided to ensure safe use.

Warnings and Precautions

This product is for external use only, so please use it as directed. Avoid getting it in your eyes, and do not apply it to wounds or damaged skin. It's important not to bandage the area tightly or use it with a heating pad, as this can cause complications.

Keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact the Poison Control Center right away. If your condition worsens, or if symptoms last more than 7 days or return after clearing up, stop using the product and consult your doctor.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your safety and health.

Pregnancy Use

There are no specific guidelines or safety concerns mentioned regarding the use of Berri-Freez Plus during pregnancy. This means that the information available does not indicate any known risks or the need for dosage adjustments for pregnant individuals. Additionally, there are no special precautions outlined for its use during this time.

As always, it's important to consult with your healthcare provider before taking any medication while pregnant to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider about any concerns you may have regarding your health and breastfeeding.

Pediatric Use

This medication is suitable for adults and children who are 2 years old and older. If your child is under 2 years of age, it’s important to consult a doctor before use. Always ensure you follow your healthcare provider's guidance regarding dosage and administration for your child's specific needs.

Geriatric Use

While there is no specific information about the use of Berri-Freez Plus in older adults, it’s important to approach any new medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before starting this medication. They can help determine if it’s appropriate for you or your loved one, considering any unique health needs or conditions. Always prioritize open communication with your doctor about any medications you are taking, especially as you age.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

Storage and Handling

To ensure the safety and effectiveness of the product, always keep the container tightly closed when not in use. It's important to store it away from heat sources and open flames to prevent any potential hazards. The ideal storage temperature ranges from 15°C to -30°C (59°F to -86°F), so make sure to keep it within this range to maintain its quality.

When handling the product, take care to follow these guidelines closely. Proper storage and handling will help ensure that the product remains safe and effective for your use.

Additional Information

You should apply the medication to the affected area no more than 3 to 4 times a day. Remember, this product is for external use only, so use it as directed. Avoid getting it in your eyes, and do not apply it to wounds or damaged skin. It's important not to bandage the area tightly or use it with a heating pad.

If your condition worsens or symptoms last more than 7 days, or if they clear up and come back within a few days, stop using the product and consult a doctor. Always cleanse and dry your skin before application, and you can use it with wet or dry bandages along with ice packs. Keep the container tightly closed, store it at room temperature (15°-30°C or 59°-86°F), and keep it away from heat and open flames. Make sure to keep it out of reach of children, and if swallowed, seek medical help or contact the Poison Control Center immediately.

FAQ

What is Berri Freez Plus used for?

Berri Freez Plus is used for adults and children 2 years of age and older. For children under 2 years of age, you should consult a doctor.

How should I apply Berri Freez Plus?

You should cleanse and dry the skin before applying Berri Freez Plus to the affected area no more than 3 to 4 times daily.

Can I use Berri Freez Plus with bandages?

Yes, Berri Freez Plus may be used with wet or dry bandages in conjunction with ice packs.

What precautions should I take when using Berri Freez Plus?

For external use only, avoid contact with eyes, do not bandage tightly, and do not apply to wounds or damaged skin. Do not use with a heating pad.

What should I do if I swallow Berri Freez Plus?

If swallowed, you should get medical attention or contact the Poison Control Center immediately.

What should I do if my condition worsens or symptoms persist?

You should stop using Berri Freez Plus and ask a doctor if your condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

How should I store Berri Freez Plus?

Keep the container tightly closed, away from heat and open flame, and store at room temperature between 15°C to 30°C (59°F to 86°F).

Are there any specific warnings for pregnant or nursing mothers?

There are no specific warnings or recommendations regarding the use of Berri Freez Plus during pregnancy or lactation in the provided text.

Is there any information on drug interactions with Berri Freez Plus?

No specific drug interactions are mentioned for Berri Freez Plus.

Packaging Info

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

Packaging configurations for Berri-Freez Plus.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Berri Freez Plus is identified by the SPL code 34089-3. The effective date of the insert is December 31, 2015. The product label is available in the media type image/jpeg.

Uses and Indications

This drug is indicated for the topical treatment of affected skin 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, dry skin, and it is recommended to limit application to no more than 3 to 4 times daily. It may be used in conjunction with wet or dry bandages and can be applied alongside ice packs for enhanced therapeutic effect.

Dosage and Administration

The medication should be applied to the affected area no more than 3 to 4 times daily. It is important to ensure that the application is performed gently and that the area is clean and dry prior to use. Healthcare professionals should instruct patients to follow the recommended frequency to optimize therapeutic outcomes while minimizing the risk of potential side effects.

Contraindications

There are no specific contraindications identified for this product. However, it is essential to adhere to the following precautions:

  • Keep out of reach of children to prevent accidental ingestion.

  • In the event of accidental swallowing, seek medical attention or contact the Poison Control Center immediately.

  • Discontinue use and consult a healthcare professional if the condition worsens or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

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, as this may lead to irritation or injury. It is imperative that the product is not applied to wounds or damaged skin, and patients should be cautioned against tightly bandaging the area of application. Additionally, the use of heating pads in conjunction with this product is contraindicated, as it may exacerbate adverse effects.

General precautions should be emphasized, particularly the importance of keeping the product out of reach of children. In the event of accidental ingestion, immediate medical attention should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. Monitoring for these signs is essential to ensure patient safety and effective management of their condition.

Side Effects

Patients should be aware that the product is intended for external use only and must be used strictly as directed. It is crucial 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 after application, nor should the product be applied to wounds or damaged skin. The use of a heating pad in conjunction with this product is also contraindicated.

In the event that a patient's condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is recommended that they stop using the product and consult a healthcare professional.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Plus (menthol, camphor, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Berri-Freez Plus.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use this medication. For children under 2 years of age, it is advised to consult a healthcare professional prior to use.

Geriatric Use

There is no specific information regarding the use of Berri-Freez Plus in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for adverse effects and therapeutic efficacy is recommended in this population, given the variability in pharmacokinetics and pharmacodynamics that may occur with aging.

Pregnancy

There are no specific statements regarding the use of Berri-Freez Plus during pregnancy. Additionally, no safety concerns related to pregnancy have been identified in the available data. There are no dosage modifications recommended for pregnant individuals, nor are there any special precautions regarding its use during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients or women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical attention or contact the Poison Control Center immediately.

Additionally, patients should be informed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. This guidance is essential to ensure patient safety and effective management of their condition.

Storage and Handling

The product is supplied in a tightly sealed container to ensure integrity and stability. It is essential to keep the container closed when not in use. The product should be stored at room temperature, specifically within the range of 15°C to -30°C (59°F to -86°F). Care should be taken to keep the product away from heat sources and open flames to maintain its quality and efficacy.

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 patients are advised to use it strictly as directed. Clinicians should counsel patients to avoid contact with the eyes, not to bandage the area tightly, and to refrain from applying it to wounds or damaged skin. Additionally, the use of heating pads in conjunction with this medication is not recommended.

Patients should be instructed to stop use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. It is crucial to keep the medication out of reach of children, and in the event of ingestion, medical attention or contact with the Poison Control Center should be sought immediately. Before application, the skin should be cleansed and dried, and the container should be kept tightly closed and stored at room temperature (15°-30°C or 59°-86°F), away from heat and open flame. The medication may be used with wet or dry bandages alongside ice packs.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Berri-Freez Plus, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.