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Jelcaine Sterile

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Active ingredient
Lidocaine Hydrochloride 20 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Jelly
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
November 10, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 20 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Jelly
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 2024
Label revision date
November 10, 2025
Manufacturer
Brookfield Pharmaceuticals, LLC
Registration number
M017
NDC root
71351-025
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

Jelcaine Sterile is a topical medication that contains Lidocaine HCl (a local anesthetic) at a concentration of 2%. It is designed to provide temporary relief from pain and itching associated with various minor skin issues, including cuts, sunburn, scrapes, burns, insect bites, and skin irritations.

By applying Jelcaine Sterile to the affected area, you can help soothe discomfort and alleviate irritation, making it a useful option for managing minor skin ailments.

Uses

If you're dealing with minor discomfort from cuts, scrapes, burns, sunburn, insect bites, or skin irritations, this medication can help provide temporary relief from pain and itching. It's designed to soothe these common skin issues, making your day a little more comfortable.

Rest assured, there are no concerns about teratogenic effects (which means it won't cause birth defects) associated with this medication, so you can use it with confidence.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication directly to the affected area of your skin. It’s important to do this no more than 3 to 4 times a day to ensure safety and effectiveness.

However, if your child is under 2 years old, you should not use this medication without first consulting a doctor. Always make sure to follow these guidelines to help manage the condition safely.

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

This product is intended for external use only. You should stop using it and consult a doctor if you experience an allergic reaction, which may include symptoms like rash or difficulty breathing. Additionally, if your condition worsens, symptoms persist for more than 7 days, or if they clear up and then return within a few days, it's important to seek medical advice. Be alert for any signs of redness, irritation, swelling, or pain that begin or worsen while using the product.

Warnings and Precautions

This product is for external use only, so please avoid ingesting it. The packaging is not child-resistant, which means you should keep it out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

You should stop using this product and consult your doctor if you experience an allergic reaction, if your condition worsens, or if symptoms persist for more than 7 days. Additionally, if you notice any redness, irritation, swelling, pain, or if any symptoms increase, it’s important to discontinue use and reach out to your healthcare provider.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital right away. Having the medication packaging or details on hand can help healthcare professionals provide the best care. Always remember, when in doubt, it’s better to be safe and get help.

Pregnancy Use

The safety of Jelcaine (lidocaine HCl jelly) during pregnancy has not been established, which means that it’s important to be cautious. If you are pregnant, this product is generally not recommended unless your healthcare provider believes that the potential benefits outweigh any risks to your developing baby. Lidocaine may pose risks to the fetus, so it’s essential to consult with your healthcare provider for personalized advice.

There are no specific dosage modifications for pregnant women, but you should only use this product under the supervision of a healthcare professional. Always prioritize open communication with your healthcare team to ensure the best outcomes for you and your baby.

Lactation Use

If you are breastfeeding, you can use Jelcaine Sterile (lidocaine hcl jelly) without specific warnings or recommendations against it. Currently, there are no known concerns about this product being passed into breast milk or any associated risks for your nursing infant.

As always, it's a good idea to consult with your healthcare provider if you have any questions or concerns about using medications while breastfeeding.

Pediatric Use

If your child is 2 years old or older, you can apply this medication to the affected area up to 3-4 times a day. However, if your child is under 2 years old, it’s important not to use this medication and to consult a doctor for guidance. Always ensure you follow these recommendations to keep your child safe and healthy.

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 you understand any necessary precautions or adjustments based on your kidney 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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can avoid any potential issues and ensure the best possible care.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). It’s acceptable for the temperature to occasionally range from 15-30°C (59-86°F), but try to keep it as close to the recommended range as possible. This 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 to ensure safety and effectiveness. If you have any questions about storage or handling, don’t hesitate to reach out for guidance.

Additional Information

For adults and children aged 2 years and older, you should apply the medication externally to the affected area no more than 3 to 4 times a day. If the patient is under 2 years old, do not use this medication and consult a doctor for guidance. There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences.

FAQ

What is Jelcaine Sterile?

Jelcaine Sterile is a formulation containing Lidocaine HCl at a concentration of 2%.

What is Jelcaine Sterile used for?

It is used for temporary relief of pain and itching due to minor cuts, sunburn, minor scrapes, minor burns, insect bites, and minor skin irritations.

How should I use Jelcaine Sterile?

Adults and children 2 years of age and older should apply it externally to the affected area not more than 3-4 times daily. Do not use in children under 2 years of age without consulting a doctor.

Are there any contraindications for using Jelcaine Sterile?

There are no specified contraindications, but it is not recommended for use in pregnant women unless the potential benefits outweigh the risks.

What should I do if I experience an allergic reaction?

Stop using Jelcaine Sterile and consult a doctor if you experience an allergic reaction, or if your condition worsens or persists for more than 7 days.

Is Jelcaine Sterile safe to use during pregnancy?

The safety of Jelcaine during pregnancy has not been established, and it should only be used under the supervision of a healthcare professional.

What should I do if Jelcaine Sterile is swallowed?

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

What are the storage conditions for Jelcaine Sterile?

Store Jelcaine Sterile at 20-25°C (68-77°F), with excursions permitted to 15-30°C (59-86°F).

Packaging Info

Below are the non-prescription pack sizes of Jelcaine Sterile (lidocaine hcl jelly usp, 2%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Jelcaine Sterile.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 2 years and older are instructed to apply the medication externally to the affected area, not exceeding 3 to 4 applications per day. For children under 2 years of age, the use of this medication is not recommended; healthcare professionals should be consulted for appropriate alternatives or guidance.

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 not designed for ingestion, and caution should be exercised to prevent accidental swallowing. In the event of ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

It is imperative to note that the packaging of this product is not child-resistant. Therefore, it should be stored out of reach of children to prevent accidental ingestion.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: an allergic reaction, worsening of the condition, persistence of symptoms beyond 7 days, or recurrence of symptoms after a temporary improvement. Additionally, if any signs of redness, irritation, swelling, pain, or other adverse symptoms develop or intensify, patients should stop using the product and seek medical advice.

In cases of accidental swallowing, immediate medical help is essential, and contacting a Poison Control Center is strongly recommended.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if an allergic reaction occurs. Additionally, if the condition worsens or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is advised to stop using the product and seek medical advice. Patients should also seek medical attention if they experience any redness, irritation, swelling, pain, or if other symptoms begin or increase.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding 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 Jelcaine Sterile (lidocaine hcl jelly usp, 2%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Jelcaine Sterile.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication externally to the affected area up to 3-4 times daily. For children under 2 years of age, the use of this medication is not recommended, and consultation with a healthcare professional is advised.

Geriatric Use

There is no specific information available 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 Jelcaine (lidocaine HCl jelly) during pregnancy has not been established. The use of this product is not recommended in pregnant women unless the potential benefits outweigh the risks to the fetus. Lidocaine may pose risks to the developing fetus; therefore, it is essential for healthcare providers to be consulted for guidance regarding its use in this population.

No specific dosage modifications for pregnant women are provided; healthcare providers should be consulted for personalized recommendations. Pregnant women should use this product only under the supervision of a healthcare professional to ensure appropriate monitoring and management of any potential risks.

Lactation

There are no specific warnings or recommendations regarding the use of Jelcaine Sterile (lidocaine hcl jelly) in lactating mothers. Additionally, there are no statements concerning the potential for excretion of lidocaine in breast milk or any associated risks to breastfed infants.

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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

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.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that the packaging of this product is not child-resistant. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction. Additionally, they should be informed to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

It is important for healthcare providers to inform patients to cease use and consult a doctor if they notice any redness, irritation, swelling, pain, or if any other symptoms begin or worsen while using the product.

Patients should also be cautioned to avoid contact with the eyes while using this product. Furthermore, they should be advised against using large quantities, especially on raw surfaces or blistered areas, to prevent potential adverse effects.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a temperature range of 20-25°C (68-77°F), with permissible excursions between 15-30°C (59-86°F), in compliance with USP Controlled Room Temperature guidelines. Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication externally to the affected area no more than 3-4 times daily. For children under 2 years of age, the use of this medication is not recommended, and consultation with a doctor is necessary. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Jelcaine Sterile, 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 Jelcaine Sterile, 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

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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.