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First Shield

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredients
  • Lidocaine Hydrochloride 5 mg/1 g
  • Benzalkonium Chloride 1.3 mg/1 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 2023
Label revision date
April 3, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Lidocaine Hydrochloride 5 mg/1 g
  • Benzalkonium Chloride 1.3 mg/1 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 2023
Label revision date
April 3, 2023
Manufacturer
Unishield
Registration number
part348
NDC root
49314-0003
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

This drug is designed to provide temporary relief from pain associated with minor burns. In addition to alleviating pain, it also helps protect the affected area from harmful bacteria, promoting a safer healing environment. If you have a minor burn, this medication can be a supportive option to help manage discomfort while protecting your skin.

Uses

You can use this product for the temporary relief of pain caused by minor burns. It also helps protect your skin from harmful bacteria, which can be important for preventing infections as your skin heals. This makes it a useful option for managing minor burn injuries effectively.

Dosage and Administration

To use this medication effectively, start by cleaning the area that needs treatment. Once the area is clean, apply a small amount of the medication. You should do this no more than 3 to 4 times a day.

If you are considering this medication for a child under 2 years old, it’s important to consult a doctor first before use. Always follow these guidelines to ensure safe and effective treatment.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should never apply it to your eyes or use it in large quantities. Additionally, avoid using it on raw surfaces, blistered areas, deep puncture wounds, animal bites, or serious burns. If you find that you need to use it for more than one week, please consult your doctor for guidance.

By following these instructions, you can help ensure that you use the medication effectively and safely. Always prioritize your health and well-being by adhering to these recommendations.

Side Effects

When using this medication, it's important to remember that it is for external use only. This means you should not apply it internally or ingest it. Always follow the guidelines provided to ensure safe and effective use. If you experience any unusual reactions or side effects, consult your healthcare provider for advice.

Warnings and Precautions

This product is intended for external use only, so please avoid ingesting it. If you accidentally swallow any of it, seek medical assistance or contact a Poison Control Center immediately.

While there are no specific laboratory tests or emergency instructions provided, it's important to stay vigilant. If you experience any unusual reactions or side effects, stop using the product and reach out to your doctor for guidance. Your health and safety are paramount, so don’t hesitate to seek help if needed.

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.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. While there are no specific contraindications listed, caution is advised since the effects on the developing fetus are unknown.

Before using this product, you should consult your healthcare provider to discuss any potential risks and to ensure it is safe for you and your baby. There are no specific dosage modifications provided for pregnant individuals, so professional guidance is essential.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, exercising caution is advised. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

If you are considering this medication for your child, it's important to know that it is not recommended for children under 2 years old. If your child falls into this age group, please consult a doctor for guidance. Always prioritize your child's safety and well-being by seeking professional advice when it comes to their health.

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 if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe for your liver health. They can help determine the best approach for your treatment based on your individual circumstances.

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 way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and avoid freezing. Each packet is tamper-evident, meaning it has a seal that shows if it has been opened or compromised. It's important to only use packets that are intact; do not use any that are opened or torn, as this could affect the product's effectiveness and safety.

By following these simple storage and handling guidelines, you can help maintain the integrity of the product and ensure a safe experience.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

The drug provides temporary relief of pain associated with minor burns and helps protect against harmful bacteria.

How should I apply this drug?

Clean the affected area and apply a small amount not more than 3-4 times daily.

Are there any age restrictions for using this drug?

Do not use this drug in children under 2 years without consulting a doctor.

What should I avoid when using this drug?

Do not use it in the eyes, in large quantities, over raw surfaces or blistered areas, or on deep puncture wounds, animal bites, or serious burns.

How long can I use this drug?

Do not use for more than one week unless directed by a doctor.

Is this drug safe to use during pregnancy?

The safety of this product during pregnancy has not been established, so consult a healthcare provider if pregnant or planning to become pregnant.

Can nursing mothers use this drug?

Nursing mothers should consult a doctor before using this product, as there is a potential for excretion in breast milk.

What should I do if I accidentally ingest this drug?

If ingested, get medical help or contact a Poison Control Center right away.

How should I store this drug?

Store at room temperature and do not freeze. Ensure packets are tamper evident and do not use any opened or torn packets.

Packaging Info

Below are the non-prescription pack sizes of First Shield (benzalkonium chloride, lidocaine hci). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for First Shield.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor burns. Additionally, it helps protect against harmful bacteria, contributing to the overall management of minor burn injuries.

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

Dosage and Administration

The affected area should be cleaned prior to application. A small amount of the product should be applied to the affected area, not exceeding 3 to 4 times daily.

For children under 2 years of age, the product should not be used without consulting a healthcare professional.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application in or around the eyes is prohibited due to the potential for irritation or injury.

  • The product should not be applied in large quantities, as excessive use may lead to adverse effects.

  • Application over raw surfaces, blistered areas, deep puncture wounds, animal bites, or serious burns is contraindicated to prevent complications and promote proper healing.

  • Prolonged use beyond one week is not recommended unless directed by a healthcare professional, as extended use may increase the risk of side effects.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid ingestion of the product. In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

While no specific laboratory tests are recommended for monitoring, it is essential for healthcare providers to remain vigilant regarding any adverse reactions or complications that may arise from the use of this product. Should any concerning symptoms develop, patients are encouraged to discontinue use and consult their healthcare provider for further evaluation and guidance.

Side Effects

Patients should be aware that the product is intended for external use only. This warning is critical to ensure safe and appropriate use, as improper application may lead to adverse reactions.

In clinical trials and postmarketing experiences, no specific adverse reactions were reported; however, the importance of adhering to the external use directive cannot be overstated. Patients are advised to monitor for any unexpected effects and to consult healthcare professionals if any concerns arise.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of First Shield (benzalkonium chloride, lidocaine hci). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for First Shield.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication without consulting a healthcare professional. Safety and efficacy have not been established in this age group, and appropriate dosing guidelines are not available. It is essential for healthcare providers to evaluate the risks and benefits before prescribing this medication to young children.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The safety of this product during pregnancy has not been established. Caution is advised as the effects on the fetus are unknown. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. No specific dosage modifications for pregnant individuals are provided.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised when considering the use of this product during lactation.

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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

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 extracted data.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of ingestion, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. It is important for patients to understand the urgency of the situation and the need for prompt action if the medication is ingested.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure safety and integrity. It is essential to store the packets at room temperature, avoiding exposure to freezing conditions. Healthcare professionals should not use 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 First Shield, 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 First Shield, 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.