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Assured

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Active ingredient
Lidocaine Hydrochloride 2.5 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
October 25, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 2.5 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
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 2014
Label revision date
October 25, 2023
Manufacturer
Zhejiang Jingwei Pharmaceutical Co. , Ltd.
Registration number
M017
NDC root
55621-010
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

You can use this medication for temporary relief of pain associated with minor burns, sunburn, minor cuts or scrapes, and minor skin irritations. It is designed to help soothe discomfort and promote healing in these common skin issues. If you experience any of these conditions, this medication may provide the relief you need.

Uses

You can use this medication for the temporary relief of pain caused by minor burns, sunburn, minor cuts or scrapes, and minor skin irritations. It’s designed to help soothe discomfort and promote a sense of relief from these common skin issues.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

To use this medication effectively, start by cleaning the affected area and gently drying it. You can then apply the medication to the area that needs treatment. For both adults and children over 2 years old, you should apply it no more than 3 to 4 times a day.

If you are caring for a child under 2 years of age, it’s important to consult a physician (doctor) before using this medication. This ensures that you receive the best guidance for their specific needs.

What to Avoid

It's important to use this medication responsibly. You should avoid using it in large quantities, especially on raw surfaces or blistered areas, as this can lead to complications. While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, always follow the guidance provided by your healthcare professional to ensure safe and effective use.

Side Effects

For your safety, this product is intended for external use only. If you notice that your condition worsens or if your symptoms last longer than 7 days, it’s important to stop using the product and consult a doctor. Additionally, if your symptoms improve and then return within a few days, you should also discontinue use and seek medical advice.

Warnings and Precautions

This product is for external use only, so please avoid using it on any internal areas. It's important to keep it out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

You should stop using this product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if your symptoms improve and then return within a few days. These steps will help ensure your safety and well-being while using the 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 feel unwell after taking the medication, 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, your safety is the top priority.

Pregnancy Use

The safety of lidocaine hydrochloride gel during pregnancy has not been established, which means that it’s unclear whether it could harm you or your developing baby. Because of this uncertainty, it is important to only use this gel if your healthcare provider believes that the benefits outweigh any potential risks to your fetus.

If you are pregnant or planning to become pregnant, you should consult your physician before using lidocaine hydrochloride gel. This will help ensure that you make informed decisions about your health and the health of your baby.

Lactation Use

If you are breastfeeding and considering the use of lidocaine hydrochloride gel, you can feel reassured that there are no specific warnings or considerations for nursing mothers regarding its use. Additionally, there are no statements indicating that lidocaine hydrochloride gel is excreted in breast milk or that it poses any risk to your infant while you are lactating. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If your child is under 2 years old, it's important to consult a physician (doctor) before using this medication. For both adults and children in this age group, you should apply the medication to the affected area no more than 3 to 4 times a day. Always follow these guidelines to ensure the safety and effectiveness of the treatment for your little one.

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 issues, 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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

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 about how different medications might work together or affect any tests you may need. Your health and safety are the top priority, and discussing these details can help prevent any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 59°F and 86°F (15°C and 30°C). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day. This means you can put it directly on the skin where you need relief, but be sure not to exceed the recommended frequency for best results. If you have any questions about how to use it or its effects, consult your healthcare provider for guidance.

FAQ

What is the primary use of this drug?

This drug is used for the temporary relief of pain associated with minor burns, sunburn, minor cuts or scrapes, and minor skin irritations.

How should I apply this drug?

You should clean the affected area, gently dry it, and apply the drug not more than 3 to 4 times daily.

Is this drug safe to use during pregnancy?

The safety of this drug during pregnancy has not been established, and it should only be used if the potential benefit justifies the potential risk to the fetus.

What should I do if my condition worsens?

You should stop using the product and consult a doctor if your condition worsens or if symptoms persist for more than 7 days.

What precautions should I take when using this drug?

Keep this drug out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Are there any contraindications for using this drug?

There are no specific contraindications mentioned, but consult a physician if you are pregnant or if you have any concerns.

Can children under 2 years use this drug?

Children under 2 years of age should consult a physician before using this drug.

What should I do if I experience an adverse reaction?

If you experience an adverse reaction, stop using the product and consult a physician.

What is the storage requirement for this drug?

Store the drug at room temperature between 59 - 86°F (15°C - 30°C).

Packaging Info

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

Packaging configurations for Assured.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor burns, sunburn, minor cuts or scrapes, and minor skin irritations.

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

Dosage and Administration

For adults and children under 2 years of age, the affected area should be cleaned and gently dried prior to application. The medication is to be applied to the affected area no more than 3 to 4 times daily.

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

Contraindications

Use is contraindicated in patients who may apply the product in large quantities, particularly over raw surfaces or blistered areas, due to the potential for adverse effects in these conditions. No other specific contraindications have been identified.

Warnings and Precautions

For external use only. This product is intended solely for topical application and should not be ingested.

It is imperative to keep this product out of the 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 any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. In such cases, it is essential to seek medical advice to determine the appropriate course of action.

In instances of ingestion, it is critical to obtain emergency medical help or contact a Poison Control Center immediately. Prompt action is necessary to ensure patient safety and appropriate management of any potential adverse effects.

Side Effects

For external use only. Patients should discontinue use and consult a physician if the condition worsens or if symptoms persist for more than 7 days. Additionally, if the condition appears to clear up and then recurs within a few days, it is advised to stop using the product and seek medical advice.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Assured.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a physician prior to use. For both adults and children in this age group, the medication should be applied to the affected area no more than 3 to 4 times daily.

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, given the lack of targeted data for this population.

Pregnancy

The safety of lidocaine hydrochloride gel during pregnancy has not been established. Use of this product is contraindicated in pregnant patients unless the potential benefit justifies the potential risk to the fetus. It is essential for pregnant women to consult a physician prior to using this product to ensure that any potential risks are adequately assessed and managed.

Lactation

Lidocaine hydrochloride gel has not been associated with specific warnings or considerations for nursing mothers. Additionally, there are no statements regarding the potential for excretion of lidocaine in breast milk or any associated risks to breastfed infants. Therefore, the use of lidocaine hydrochloride gel during lactation appears to be without significant concern.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 prescribing information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management for suspected cases of overdose.

It is essential to monitor patients 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.

For further management, consultation with a poison control center or a medical toxicologist is recommended to obtain guidance tailored to the specific circumstances of 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 understanding of the compound's potential effects in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be cautioned against using the product in large quantities, especially on raw surfaces or blistered areas. It is important to inform patients that they should stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes while using this product.

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, maintaining a range of 59°F to 86°F (15°C to 30°C). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically, with application to the affected area recommended no more than 3 to 4 times daily. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Assured, 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 Assured, 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.