Benzalkonium chloride/Lidocaine hydrochloride

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with sunburn, minor burns, insect bites, 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 is to 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 to ensure appropriate care and dosage.

Contraindications

Use is contraindicated in the following situations:

• Application in or around the eyes is prohibited due to the potential for irritation or damage to ocular tissues.

• The product should not be applied over large areas of the body, on deep puncture wounds, animal bites, or serious burns, as these conditions may increase the risk of adverse effects.

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

Warnings and Precautions

For external use only. This product is contraindicated for application in the eyes and should not be used over large areas of the body, on deep puncture wounds, animal bites, or serious burns. Caution is advised against the use of large quantities, particularly on raw surfaces or blistered areas.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if the condition worsens, if the condition resolves and then recurs within a few days, or if the condition persists for more than 7 days.

It is imperative to keep this product out of reach of children. In the event of ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Side Effects

Patients using this product may experience adverse reactions, which can vary in seriousness and frequency.

Serious adverse reactions include the potential for severe irritation or allergic reactions, particularly if the product is applied to sensitive areas or inappropriately used. It is crucial to note that this product is for external use only and should not be applied in or around the eyes, over large areas of the body, on deep puncture wounds, animal bites, or serious burns.

Common adverse reactions may include localized irritation or discomfort at the application site. Patients are advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms clear up and then recur within a few days, or if the condition persists for more than 7 days.

In clinical settings, it is recommended that pregnant or breastfeeding individuals seek advice from a healthcare professional prior to use. Additionally, this product should be kept out of reach of children, and in the event of accidental ingestion, medical assistance should be sought immediately or contact with a Poison Control Center (1-800-222-1222) should be made.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of 2677 First Aid Burn Cream. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may use this product by cleaning the affected area and applying a small amount 3 to 4 times daily. The treated area may be covered with a sterile bandage if desired.

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

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy.

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 dosage adjustments, special monitoring, or safety considerations outlined in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of detailed information necessitates careful clinical judgment. Regular monitoring of renal function may be advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdose, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdose.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 without delay. This information is vital for ensuring prompt and appropriate care in case of an emergency.

Storage and Handling

The product is supplied in tamper-evident sealed packets, ensuring the integrity and safety of the contents. It is essential to store the packets in a cool, dry area, maintaining a temperature range of 15º to 25º C (59º to 77º F). Healthcare professionals are advised to refrain from using any packets that are opened or torn, as this may compromise the product's quality and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for 2677 First Aid Burn Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)