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Signature Care Aloe Vera Gel with Lidocaine

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Active ingredient
Lidocaine Hydrochloride 8 mg/1 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 2011
Label revision date
August 14, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 8 mg/1 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 2011
Label revision date
August 14, 2025
Manufacturer
Safeway, Inc.
Registration number
M017
NDC root
21130-733
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 medication is designed to provide temporary relief from pain and itching caused by various skin issues, including sunburn, minor burns, cuts, scrapes, insect bites, and other minor skin irritations. It helps soothe discomfort and promote a sense of relief when you experience these common skin problems.

Uses

If you're dealing with discomfort from sunburn, minor burns, cuts, scrapes, insect bites, or other minor skin irritations, this product can help provide temporary relief from pain and itching. It's designed to soothe your skin and make you feel more comfortable during the healing process.

Rest assured, there are no concerns about teratogenic effects (which means it won't cause birth defects) associated with this product, making it a safer choice for those who may be pregnant.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

For children under 2 years of age, it’s important to consult a doctor before use. This will help ensure the safety and effectiveness of the treatment for younger children. Always follow your healthcare provider's advice regarding the application and frequency of the medication.

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 could lead to complications. While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, 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. If you notice that your condition worsens, if your symptoms last longer than seven days, or if your symptoms improve and then return within a few days, it’s important to stop using the product and consult a doctor. Your health and safety are paramount, so don’t hesitate to seek professional advice if you have any concerns.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. If you accidentally ingest it, seek medical help or contact a Poison Control Center right away.

You should stop using this product and call your doctor if your condition worsens, if your symptoms last longer than 7 days, or if your symptoms improve and then return within a few days. It's important to monitor your health and take these steps to ensure your safety.

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.

Pregnancy Use

The safety of lidocaine during pregnancy has not been established, and it is generally contraindicated due to potential risks to the fetus. If you are pregnant or planning to become pregnant, it is crucial to discuss the use of lidocaine with your healthcare provider. They can help determine if the potential benefits outweigh the risks to your baby.

If you do need to use lidocaine while pregnant, be aware that dosage adjustments may be necessary. Always consult your healthcare provider for personalized advice and guidance regarding your specific situation.

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 is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When using this medication for children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it's important to consult a doctor before use. This ensures that you are following the safest guidelines for your child's health. Always prioritize their well-being by seeking professional advice when needed.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering any unique health needs or conditions that may be present. Always keep an open line of communication with your doctor about how the medication is affecting you, especially if you notice any changes in your health or well-being.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because renal impairment (kidney issues) can affect how your body processes certain drugs. To ensure your safety, your healthcare provider will monitor your creatinine clearance (a test that measures how well your kidneys are filtering waste) regularly.

Additionally, regular renal function tests are essential to keep track of your kidney health. If you have significant renal impairment, special monitoring will be necessary to manage your treatment effectively. Always communicate with your healthcare team about your kidney function to ensure the best care.

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 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 inform your doctor about all the medications, supplements, and tests you are undergoing. This helps them monitor your health effectively and make informed decisions about your treatment plan. Your safety and well-being are the top priority, so don't hesitate to ask questions or express any concerns you may have.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. Following these simple steps will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, it's important to consult a doctor before use.

FAQ

What is the drug used for?

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

How should I use this drug?

For adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily. For children under 2 years of age, consult a doctor.

Are there any contraindications for this drug?

There are no specified contraindications, but it is contraindicated in pregnancy due to potential risks to the fetus.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.

What precautions should I take when using this drug?

This drug is for external use only. If swallowed, seek medical help or contact a Poison Control Center immediately.

How should I store this drug?

Store at room temperature, protect from light, keep the container tightly closed, and discard after opening.

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 nursing mothers know about this drug?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

Are there any specific instructions for patients with renal impairment?

Patients with reduced renal function may need dosage adjustments, and their creatinine clearance should be monitored regularly.

Packaging Info

Below are the non-prescription pack sizes of Signature Care Aloe Vera Gel with Lidocaine (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Signature Care Aloe Vera Gel with Lidocaine.
Details

Drug Information (PDF)

This file contains official product information for Signature Care Aloe Vera Gel with Lidocaine, 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 and is designated with the chemical names SY74630E6 and SY74630F6. Further details regarding its molecular weight, chemical formula, dosage form, and appearance are not provided in the extracted facts.

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is properly prepared prior to administration.

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

Contraindications

The product should not be used in large quantities, particularly over raw surfaces or blistered areas, due to the potential for increased irritation or adverse effects in these conditions. No other specific contraindications have been identified.

Warnings and Precautions

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

Patients should be instructed to discontinue use and consult a healthcare provider 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. These actions are crucial to ensure patient safety and effective management of their condition.

In cases of ingestion, it is essential to emphasize the importance of seeking emergency medical help or contacting a Poison Control Center immediately. This precaution is vital to mitigate potential adverse effects associated with the product.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Signature Care Aloe Vera Gel with Lidocaine (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Signature Care Aloe Vera Gel with Lidocaine.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor before 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

The safety of lidocaine during pregnancy has not been established. Lidocaine is contraindicated in pregnancy due to potential risks to the fetus. Healthcare professionals should consider the use of lidocaine during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Dosage adjustments may be necessary for pregnant individuals; therefore, it is essential to consult a healthcare provider for guidance on appropriate dosing in this population.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments based on their level of kidney function. It is essential for healthcare professionals to monitor creatinine clearance in patients with reduced renal function to ensure appropriate dosing. Regular renal function tests should be performed to assess kidney health and detect any changes that may impact treatment. Additionally, special monitoring is required for patients with significant renal impairment to mitigate potential risks associated with medication use.

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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient effectively.

Overall, vigilance and prompt intervention are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek medical help or contact a Poison Control Center immediately if the product is swallowed. It is important to inform patients not to use the product in large quantities, especially over raw surfaces or blistered areas, to prevent potential complications.

Patients should be instructed to 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. In the event of accidental eye contact, patients should rinse their eyes with water to remove the product.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being 3 to 4 times daily to the affected area. For children under 2 years of age, it is advised to consult a doctor before use. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Signature Care Aloe Vera Gel with Lidocaine, 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 Signature Care Aloe Vera Gel with Lidocaine, 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.