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Afassco First Aid Burn Cream

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This product has been discontinued

Active ingredients
  • Lidocaine Hydrochloride 0.005 g/1 g
  • Benzalkonium Chloride 0.0013 g/1 g
Other brand names
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2018
Label revision date
January 9, 2019
Active ingredients
  • Lidocaine Hydrochloride 0.005 g/1 g
  • Benzalkonium Chloride 0.0013 g/1 g
Other brand names
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2018
Label revision date
January 9, 2019
Manufacturer
Afassco Inc.
Registration number
part348
NDC root
51532-4622

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Drug Overview

Afassco® is a first aid and burn cream designed to help prevent infection and provide temporary relief from pain and itching associated with minor cuts, scrapes, and burns. This cream is a useful addition to your first aid supplies, ensuring you have a way to care for small injuries effectively.

Manufactured by Afassco, Inc., it meets ANSI Z308.1 compliance standards, which means it adheres to specific safety and quality guidelines. Afassco® is available in various package sizes, making it convenient for both home and travel use.

Uses

You can use this product for first aid to help prevent infection in minor cuts, scrapes, and burns. It also provides temporary relief from pain and itching associated with these injuries. This means that if you have a small wound or burn, this product can help keep it clean and make you feel more comfortable while it heals.

Rest assured, there are no known harmful effects on developing babies (teratogenic effects) or other non-harmful effects mentioned, making it a safe option for your first aid needs.

Dosage and Administration

To use this medication effectively, start by cleaning the affected area thoroughly. Once it’s clean, apply a small amount of the medication directly to the area. You should do this no more than three times a day to avoid overuse. If you prefer, you can cover the area with a sterile bandage after applying the medication to help protect it.

What to Avoid

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you or someone else accidentally takes this medication, please contact a Poison Control Center immediately for assistance.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always use it responsibly and follow any additional guidance provided by your healthcare professional.

Side Effects

It's important to be aware of some warnings associated with this product. It is meant for external use only, so you should avoid applying it to your eyes or using it in large amounts. Additionally, do not use it on raw blistered areas, deep puncture wounds, animal bites, or serious burns. You should also limit its use to no more than one week.

If you experience any adverse reactions while using this product, please consult a healthcare professional for guidance.

Warnings and Precautions

This product is for external use only, so please avoid using it on your eyes or in large amounts. Do not apply it to raw, blistered areas, deep puncture wounds, animal bites, or serious burns, and limit its use to no more than one week.

Keep this product out of reach of children. If someone accidentally ingests it, contact a Poison Control Center immediately for assistance. Always prioritize safety when using any medication.

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 unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

It’s important to know that the safety of this product during pregnancy has not been evaluated. While there are no specific contraindications listed, caution is advised since the effects of lidocaine and benzalkonium chloride on pregnant individuals have not been established. Currently, there is no information available regarding potential risks to the fetus, and no dosage modifications or special precautions are provided for pregnant individuals.

If you are pregnant or planning to become pregnant, it’s best to consult with your healthcare provider before using this product to ensure it’s 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 the use of this product while nursing. Additionally, there are no known concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about its effects on your milk production or your baby's health.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If your child does ingest it, you should contact a Poison Control Center immediately for guidance. Taking these precautions can help ensure your child's safety.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that the drug insert does not provide guidelines tailored for elderly patients.

If you are caring for an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach to medication management, considering any unique health needs or conditions that may be present. Always prioritize open communication with healthcare professionals to ensure safe and effective treatment.

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.

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 plan.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep it in a clean environment to ensure it remains safe for use.

If you have any questions about disposal or specific handling techniques, please refer to the guidelines provided with your product.

Additional Information

No further information is available.

FAQ

What is Afassco®?

Afassco® is a first aid/burn cream designed to help prevent infection and provide temporary relief from pain and itching associated with minor cuts, scrapes, and burns.

How should I use Afassco®?

Clean the affected area and apply a small amount of Afassco® up to three times daily. You may cover the area with a sterile bandage.

Are there any contraindications for using Afassco®?

There are no specific contraindications listed for Afassco®, but it should not be used in the eyes or on deep puncture wounds, animal bites, or serious burns.

What precautions should I take when using Afassco®?

Keep Afassco® out of reach of children. If ingested, contact a Poison Control Center immediately. It is for external use only.

Can I use Afassco® during pregnancy?

The safety of Afassco® during pregnancy has not been established, and caution is advised due to the ingredients lidocaine and benzalkonium chloride.

Is Afassco® safe for nursing mothers?

There are no specific warnings or recommendations regarding the use of Afassco® by nursing mothers.

What should I do if I experience side effects?

If you experience any adverse effects, discontinue use and consult a healthcare professional.

How should I store Afassco®?

Store Afassco® at room temperature.

Packaging Info

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

Packaging configurations for Afassco First Aid Burn Cream.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Afassco® is a first aid and burn cream indicated for the treatment of minor burns and skin irritations. The product is available in packaging options of 6 count and 25 count, as well as individual 1 gram packets. It is manufactured for Afassco, Inc., located in Minden, NV 89423. The product complies with ANSI Z308.1 standards, ensuring it meets recognized safety and performance criteria. The UPC code for Afassco® is 6 70254 20339 9.

Uses and Indications

This drug is indicated for first aid to help prevent infection in minor wounds. It provides temporary relief of pain and itching associated with minor cuts, scrapes, and burns.

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

Dosage and Administration

The affected area should be cleaned thoroughly prior to application. A small amount of the medication should be applied to the affected area, with a maximum frequency of three times daily. If desired, the treated area may be covered with a sterile bandage to protect it.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of ingestion, immediate contact with a Poison Control Center is advised.

Warnings and Precautions

The product is intended for external use only. It is imperative that the product not be applied in or around the eyes. Additionally, it should not be used in large quantities, over raw blistered areas, on deep puncture wounds, animal bites, or serious burns. The duration of use should not exceed one week to prevent potential adverse effects.

General precautions must be observed to ensure safety. The product should be kept out of reach of children to prevent accidental ingestion. In the event of ingestion, it is crucial to contact a Poison Control Center immediately for guidance.

No specific laboratory tests are recommended for monitoring the use of this product. However, healthcare professionals should remain vigilant for any signs of adverse reactions or complications associated with its use.

Side Effects

Patients should be aware that the product is intended for external use only. It is contraindicated for use in the eyes and should not be applied in large quantities, over raw blistered areas, on deep puncture wounds, animal bites, or serious burns. Additionally, the product should not be used for more than one week.

In clinical practice, adherence to these warnings is crucial to minimize the risk of adverse reactions. Failure to comply with these guidelines may lead to serious complications or exacerbate existing conditions. Therefore, patients are advised to follow the recommended usage instructions closely to ensure safety and efficacy.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Afassco First Aid Burn Cream.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of ingestion, it is crucial to contact a Poison Control Center immediately for guidance.

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

The product has not been evaluated for safety during pregnancy. Caution is advised as the safety of lidocaine and benzalkonium chloride during pregnancy has not been established. There is no specific information available regarding risks to the fetus. Additionally, no specific dosage modifications are recommended for pregnant individuals, and no special precautions are outlined for use during pregnancy. Healthcare professionals should weigh the potential benefits against any unknown risks when considering this product for pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during the use of this product.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of ingestion, patients should be instructed to contact a Poison Control Center immediately for guidance and assistance. It is essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Afassco 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 Afassco 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.