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Dynarex Burn Cream

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This product has been discontinued

Active ingredients
  • Lidocaine Hydrochloride 0.5 g/100 g
  • Benzalkonium Chloride 0.13 g/100 g
Other brand names
Dosage form
Cream
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
April 11, 2016
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Lidocaine Hydrochloride 0.5 g/100 g
  • Benzalkonium Chloride 0.13 g/100 g
Other brand names
Dosage form
Cream
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
April 11, 2016
Manufacturer
Dynarex Corporation
Registration number
part348
NDC root
67777-412
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

Dynarex Burn Cream is a topical medication designed to provide temporary relief from pain and itching caused by various skin irritations. You can use it for conditions such as sunburn, minor burns, insect bites, minor skin irritation, cuts, and scrapes. This cream helps soothe your skin and alleviate discomfort, making it a helpful option for treating these common issues.

Uses

You can use this medication for temporary relief from pain and itching caused by various skin issues. It is effective for soothing discomfort associated with sunburn, minor burns, insect bites, and minor skin irritations. Additionally, it can help alleviate pain from cuts and scrapes.

This product is designed to provide quick relief, making it a handy option for everyday skin irritations. Whether you've spent too long in the sun or have a pesky insect bite, this medication can help you feel more comfortable.

Dosage and Administration

To use this product effectively, start by cleaning the affected area thoroughly. Once it's clean, apply a small amount of the product directly to the area you want to treat. You should do this 3 to 4 times each day for the best results. If you prefer, you can cover the area with a sterile bandage to help protect it.

If you are using this product for a child under 2 years old, it's important to consult a doctor before applying it. This ensures that the treatment is safe and appropriate for their age.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should not apply it in or around your eyes, as this can cause irritation. Additionally, avoid using it over large areas of your body, on deep puncture wounds, animal bites, or serious burns. Be cautious not to use large quantities, especially on raw surfaces or blistered areas, as this can lead to complications.

By following these guidelines, you can help ensure that you use the medication effectively and safely. If you have any questions or concerns about its use, please consult your healthcare provider for more information.

Side Effects

This product is intended for external use only. You should stop using it and consult a doctor if your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return after a few days. Additionally, if you are pregnant or breastfeeding, it's important to speak with a healthcare professional before using this product.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or on large areas of your body, especially over deep puncture wounds, animal bites, or serious burns. It's important to keep this product out of the reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

You should stop using the product and consult your doctor if your condition worsens, if symptoms last more than 7 days, or if they improve and then return within a few days. If you are pregnant or breastfeeding, please talk to a healthcare professional before using this product.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are concerned about a possible overdose, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any doubts about your health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this product. For children aged 2 years and older, you can apply a small amount to the affected area 3 to 4 times a day after cleaning it. If needed, you may cover the area with a sterile bandage to protect it. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information about the use of Dynarex Burn Cream in older adults, it's important to approach any new treatment 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 using this cream. They can provide personalized advice based on your health status and any other medications you may be taking. Always prioritize safety and ensure that any treatment is appropriate for your individual needs.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

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 or tests you may be taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions and share your complete list of medications and tests with them.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry area, ideally between 59°F to 79°F (15°C to 25°C). This temperature range helps maintain the quality of the device. Always check that the packets are tamper evident and sealed; do not use any packets that are open or torn, as this could compromise the product's integrity.

When handling the product, be sure to follow these storage guidelines closely to avoid any potential issues. Proper storage and handling are essential for your safety and the product's performance.

Additional Information

You should apply a small amount of this product to the affected area on your skin 3 to 4 times a day. This topical application is suitable for both adults and children aged 2 years and older. If you have any questions about how to use the product or its effects, be sure to consult with a healthcare professional.

FAQ

What is Dynarex Burn Cream used for?

Dynarex Burn Cream is used for temporary relief of pain and itching associated with sunburn, minor burns, insect bites, minor skin irritation, cuts, and scrapes.

How should I use Dynarex Burn Cream?

For adults and children 2 years and over, clean the affected area and apply a small amount of the cream 3 or 4 times daily. It may be covered with a sterile bandage.

Is Dynarex Burn Cream safe for children under 2 years?

If you are considering using Dynarex Burn Cream on a child under 2 years, you should consult a doctor first.

Are there any contraindications for using Dynarex Burn Cream?

No specific contraindications are mentioned for Dynarex Burn Cream.

What should I avoid when using Dynarex Burn Cream?

Do not use Dynarex Burn Cream in the eyes, over large areas of the body, on deep puncture wounds, animal bites, or serious burns, and avoid using it in large quantities over raw surfaces or blistered areas.

What should I do if my condition worsens or does not improve?

Stop using Dynarex Burn Cream and ask a doctor if your condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again in a few days.

Can I use Dynarex Burn Cream if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using Dynarex Burn Cream.

What are the storage instructions for Dynarex Burn Cream?

Store Dynarex Burn Cream in a cool, dry area at temperatures between 59°F to 79°F (15°C to 25°C) and ensure the packets are tamper evident and not open or torn.

Is Dynarex Burn Cream a controlled substance?

No, Dynarex Burn Cream is not classified as a controlled substance.

Packaging Info

Below are the non-prescription pack sizes of Dynarex Burn Cream (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dynarex Burn Cream.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Dynarex Burn Cream is a topical formulation specifically designed for the treatment of burns. This cream is intended to provide relief and promote healing in affected areas. The product is presented in a cream dosage form, facilitating easy application to the skin.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with various dermatological conditions, including sunburn, minor burns, insect bites, minor skin irritation, cuts, and scrapes.

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

Dosage and Administration

For adults and children aged 2 years and older, the affected area should be cleaned prior to application. A small amount of the product should be applied to the area 3 to 4 times daily. If desired, the treated area may be covered with a sterile bandage to protect it.

For children under 2 years of age, it is recommended to consult a doctor before use.

Contraindications

Use is contraindicated in the following situations:

  • Application in the eyes is prohibited due to potential irritation and damage to ocular tissues.

  • The product should not be applied over large areas of the body or on deep puncture wounds, animal bites, or serious burns, as this may lead to adverse effects and complications.

  • Avoid using large quantities, especially on raw surfaces or blistered areas, to prevent exacerbation of skin irritation or other adverse reactions.

Warnings and Precautions

FOR EXTERNAL USE ONLY. This product is intended solely for external application and should not be ingested.

It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Contraindications for Use This product should not be applied in or around the eyes. It is also contraindicated for use over large areas of the body, on deep puncture wounds, animal bites, or serious burns. Caution should be exercised to avoid application in large quantities, especially on raw surfaces or blistered areas.

Discontinuation of Use Users should discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, pregnant or breastfeeding individuals should seek advice from a healthcare professional prior to use.

Side Effects

Patients should be aware that the product is intended for external use only.

In the event that the condition worsens, symptoms persist for more than 7 days, or symptoms clear up and then recur within a few days, patients are advised to stop use and consult a healthcare professional. Additionally, it is recommended that individuals who are pregnant or breastfeeding seek guidance from a health professional prior to using 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 Dynarex Burn Cream (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dynarex Burn Cream.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 years and older, the affected area should be cleaned prior to application. A small amount of the product should be applied to the area 3 to 4 times daily, and it may be covered with a sterile bandage if desired.

Geriatric Use

Elderly patients may not have specific information regarding the use of Dynarex Burn Cream, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or unexpected responses to treatment, 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and breastfeeding safety. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the health and safety of both the patient 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 mothers.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 further management and treatment options.

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

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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. In the event of swallowing the medication, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be informed about specific situations in which the medication should not be used. It should not be applied in or around the eyes, over large areas of the body, or on deep puncture wounds, animal bites, or serious burns. Additionally, patients should avoid using the medication in large quantities, especially on raw surfaces or blistered areas.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than seven days, or if symptoms improve and then recur within a few days. Furthermore, patients who are pregnant or breastfeeding should be advised to consult a healthcare professional before using the medication.

Storage and Handling

The product is supplied in tamper-evident sealed packets. It is essential to ensure that no open or torn packets are used. For optimal storage conditions, the product should be kept in a cool, dry area, maintaining a temperature range of 59°F to 79°F (15°C to 25°C). Proper adherence to these storage guidelines will help maintain the integrity and efficacy of the product.

Additional Clinical Information

The product is administered topically, with a recommended application of a small amount to the affected area three to four times daily for adults and children aged 2 years and older. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Dynarex Burn Cream, 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 Dynarex Burn Cream, 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

Last AI update:

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.