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Top Safety First Aid 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 2016
Label revision date
March 12, 2019
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 2016
Label revision date
March 12, 2019
Manufacturer
Top Safety Products Company Inc
Registration number
part348
NDC root
51395-412
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

Top Safety First Aid 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 sunburn, minor burns, insect bites, as well as cuts and scrapes. This cream helps soothe discomfort and supports the healing process for these common skin issues.

Uses

If you're dealing with discomfort from sunburn, minor burns, insect bites, or other minor skin irritations, this medication can help provide temporary relief from pain and itching. It’s also effective for soothing cuts and scrapes, making it a handy option for various minor skin issues.

You can use this treatment to ease the discomfort associated with these common skin problems, allowing you to feel more comfortable as you heal.

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 a day for the best results. If you prefer, you can cover the area with a sterile bandage to 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 never apply it in or around your eyes, as this can cause serious harm. 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 within 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 any internal areas. Keep it out of reach of children, and if it is swallowed, seek medical help immediately or contact a Poison Control Center.

If you notice that your condition worsens, symptoms last longer than 7 days, or if symptoms improve and then return within a few days, stop using the product and consult your doctor. Additionally, if you are pregnant or breastfeeding, it’s important to 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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you think something might be wrong.

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 the area. If needed, you may cover it with a sterile bandage to protect the area. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Remember, even if there are no specific dosage adjustments or safety concerns mentioned, your healthcare provider may still recommend monitoring for any potential side effects or interactions with other medications you may be taking. Always prioritize open communication with your healthcare team to ensure the best care.

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 for patients with renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment and what steps to take for your safety.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions and share all the medications and supplements you are using. This helps your provider monitor your health effectively and make informed decisions about your treatment.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry area, ideally at temperatures between 59°F and 79°F (15°C to 25°C). This helps maintain its quality and performance.

When handling the product, always use tamper-evident sealed packets. Avoid using any packets that are open or torn, as this could compromise the product's integrity. Following these guidelines will help you use the product safely and effectively.

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 Top Safety First Aid Burn Cream used for?

Top Safety First Aid 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 this 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.

Can children under 2 years use this cream?

Children under 2 years should consult a doctor before using this cream.

Are there any contraindications for this cream?

There are no specific contraindications mentioned for Top Safety First Aid Burn Cream.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens, if symptoms persist for more than 7 days, or if they clear up and occur again in a few days.

Is this cream safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using this cream.

What precautions should I take when using this cream?

This cream is for external use only. Avoid using it in the eyes, over large areas of the body, or on deep puncture wounds, animal bites, or serious burns.

How should I store this cream?

Store the cream in a cool, dry area at temperatures between 59°F to 79°F (15°C to 25°C) and use tamper-evident sealed packets.

Packaging Info

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

Packaging configurations for Top Safety First Aid Burn Cream.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Top Safety First Aid Burn Cream is a topical formulation designed for the management of minor burns. The cream is specifically formulated to provide soothing relief and promote healing. It is presented in a convenient dosage form suitable for application to affected areas. The product is characterized by its cream-like consistency, which facilitates easy application and absorption into 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. The product should not be applied over large areas of the body or on deep puncture wounds, animal bites, or serious burns due to the potential for adverse effects. Additionally, the use of large quantities, especially over raw surfaces or blistered areas, is contraindicated to prevent complications.

Warnings and Precautions

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

General precautions must be observed to ensure safe use. 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.

Healthcare professionals should advise patients to discontinue use and consult a physician 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 guidance 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 if 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 Top Safety First Aid Burn Cream (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Top Safety First Aid 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, and a small amount of the product should be applied 3 to 4 times daily. The area may be covered with a sterile bandage if desired.

Geriatric Use

There is no specific information 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 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 in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms related to overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the lack of documented information.

Management Procedures In the absence of specific antidotes or treatment protocols, standard emergency procedures should be followed. This may include gastric decontamination, if appropriate, and the administration of supportive measures tailored to the patient's needs. Consultation with a poison control center or a medical toxicologist is recommended for further guidance in managing suspected overdosage cases.

Healthcare professionals are encouraged to report any cases of overdosage to the relevant authorities to enhance the understanding of the drug's safety profile.

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 fully evaluate the nonclinical toxicology profile.

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 to ensure integrity and safety. It is essential to avoid using any packets that are open or torn.

For optimal storage, 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 conditions is crucial to preserve the product's quality and efficacy.

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. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Top Safety First Aid 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 Top Safety First Aid 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.