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Signature Care Lidocaine Cream

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Active ingredient
Lidocaine Hydrochloride 40 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2020
Label revision date
November 21, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 40 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2020
Label revision date
November 21, 2024
Manufacturer
Better Living Brands LLC
Registration number
M017
NDC root
21130-544
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

Signature Care is a maximum strength pain-relieving cream that contains 4% lidocaine (a local anesthetic that numbs the skin). It is designed to temporarily relieve minor pain, making it a helpful option for those seeking quick relief from discomfort.

This cream comes in a 2.7 oz (76g) tube, providing a convenient way to apply the medication directly to the affected area. Whether you're dealing with minor aches or pains, Signature Care aims to offer soothing relief when you need it most.

Uses

You can use this medication to temporarily relieve minor pain. It’s designed to help you feel more comfortable when dealing with everyday aches and discomforts. Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) or nonteratogenic effects associated with this medication.

Dosage and Administration

When using this medication, if you are an adult or a child over 12 years old, you should apply a thin layer to the affected area every 6 to 8 hours. However, make sure not to exceed more than 3 applications within a 24-hour period.

If the patient is a child under 12 years old, it’s important to consult a doctor before use. This ensures that the treatment is safe and appropriate for younger individuals. Always follow these guidelines to ensure effective and safe use of the medication.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should not apply it to large areas of your body or on any cut, irritated, or swollen skin. Additionally, avoid using it on puncture wounds. If you find that you need to use it for more than one week, please consult your doctor first.

Make sure to keep it away from your eyes, and do not cover the treated area with a bandage or apply local heat, such as heating pads. Following these guidelines will help ensure your safety while using this medication.

Side Effects

When using this product, it's important to follow the directions carefully. You should only apply it to the skin and avoid using it on large areas, cut or irritated skin, puncture wounds, or for more than a week without consulting a doctor. Be cautious to keep it away from your eyes and do not use bandages or heat on the treated area.

If your condition worsens, if symptoms last longer than seven days, or if they improve and then return shortly after, stop using the product and consult a doctor. Additionally, if you are pregnant or breastfeeding, it's best to speak with a healthcare professional before using this product.

Warnings and Precautions

This product is for external use only, so please avoid applying it to large areas of your body or on any cut, irritated, or swollen skin. It should not be used on puncture wounds, and you should not use it for more than one week without consulting your doctor. Always follow the directions on the packaging carefully, and be sure to keep it away from your eyes. Additionally, do not cover the treated area with bandages or apply heat, like heating pads.

If your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and contact your doctor. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product.

In case of accidental swallowing, seek emergency medical help or contact the Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting your local Poison Control Center or going to the nearest emergency room.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, acting quickly can make a significant difference in the outcome.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If your child is under 12 years old, it's important to consult with a doctor before using this medication. For those aged 12 and older, you can apply a thin layer of the product to the affected area every 6 to 8 hours. However, be sure not to exceed three applications within a 24-hour period to ensure safety and effectiveness. Always follow these guidelines to help protect your child's 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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication about any concerns you may have regarding medication use.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering 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).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 20° and 25°C (68° and 77°F). This temperature range helps maintain the integrity of the device.

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

No further information is available.

FAQ

What is Signature Care?

Signature Care is a maximum strength pain-relieving cream that contains 4% Lidocaine and comes in a 2.7 oz (76g) tube.

What does Signature Care do?

It temporarily relieves minor pain.

How should I use Signature Care?

For adults and children over 12 years, apply a thin layer to the affected area every 6 to 8 hours, not exceeding 3 applications in a 24-hour period.

Can children under 12 use Signature Care?

Children under 12 years should ask a doctor before use.

Are there any warnings for using Signature Care?

Yes, it is for external use only. Do not allow contact with the eyes, and do not use on large areas of the body, cut, irritated, or swollen skin.

What should I do if my condition worsens while using Signature Care?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

Is it safe to use Signature Care if I am pregnant or breastfeeding?

If pregnant or breastfeeding, you should ask a health professional before use.

What should I do if I accidentally swallow Signature Care?

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

How should I store Signature Care?

Store at controlled room temperature between 20°-25°C (68°-77°F).

Packaging Info

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

Packaging configurations for Signature Care Lidocaine Cream.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Signature Care NDC 21130-544-27 is a maximum strength pain-relieving cream containing 4% lidocaine. The product is formulated to provide localized relief from pain. It is packaged in a net weight of 2.7 oz (76 g).

Uses and Indications

This drug is indicated for the temporary relief of minor pain.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children over 12 years of age, a thin layer of the medication should be applied to the affected area every 6 to 8 hours. The total number of applications must not exceed 3 times within a 24-hour period.

For children under 12 years of age, it is recommended to consult a physician prior to use.

Contraindications

Use is contraindicated in the following situations:

  • Application on large areas of the body or on cut, irritated, or swollen skin is not recommended due to the potential for increased absorption and adverse effects.

  • Application on puncture wounds is contraindicated to prevent complications.

  • Prolonged use beyond one week without medical consultation is contraindicated to avoid potential adverse reactions.

  • Contact with the eyes must be avoided to prevent irritation or injury.

  • Bandaging or applying local heat (such as heating pads) to the area of use is contraindicated as it may enhance absorption and increase the risk of side effects.

Warnings and Precautions

For external use only. This product is contraindicated for application on large areas of the body, as well as on cut, irritated, or swollen skin. It should not be used on puncture wounds. Prolonged use beyond one week is not recommended without prior consultation with a healthcare professional.

When utilizing this product, it is imperative to adhere strictly to the provided directions. Users must read and follow all instructions and warnings indicated on the packaging. Care should be taken to avoid contact with the eyes. Additionally, the area of application should not be bandaged or subjected to local heat, such as heating pads.

Discontinuation of use and consultation with a healthcare provider is advised if the condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. Pregnant or breastfeeding individuals should seek guidance from a health professional prior to use.

In the event of ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for application on large areas of the body, on cut, irritated, or swollen skin, and on puncture wounds. Additionally, it should not be used for more than one week without consulting a healthcare professional.

When using this product, it is essential to adhere strictly to the directions provided. Patients should avoid contact with the eyes and refrain from bandaging or applying local heat, such as heating pads, to the area of use.

Patients are advised to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days. Furthermore, pregnant or breastfeeding individuals should seek advice from a healthcare professional before using this product.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Signature Care Lidocaine Cream.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is to apply a thin layer to the affected area every 6 to 8 hours, with a maximum of 3 applications within a 24-hour period.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully evaluated in these populations to ensure maternal and fetal safety.

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 have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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 overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact the Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate management strategy.

Healthcare providers should be prepared to implement supportive care and symptomatic treatment as necessary, based on the clinical presentation of the patient. Continuous monitoring and evaluation may be required to ensure patient safety and effective management of any complications arising from the overdosage.

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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of the reach of children and pets to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should seek medical help or contact the Poison Control Center immediately.

Patients should be informed not to use the medication on large areas of the body or on cut, irritated, or swollen skin, and it should not be applied to puncture wounds. Emphasize the importance of using the medication only as directed, and encourage patients to read and follow all directions and warnings provided on the carton.

It is crucial to inform patients to avoid contact with the eyes and to refrain from bandaging or applying local heat, such as heating pads, to the area of use. Patients should be instructed to stop using the medication and consult a doctor if their condition worsens or if symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days.

Additionally, healthcare providers should remind patients who are pregnant or breastfeeding to consult a health professional before using the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20°-25°C (68°-77°F) to maintain its efficacy and stability. Proper container requirements must be adhered to, ensuring that the product is kept in its original packaging to prevent degradation. Special handling needs should be observed to avoid exposure to extreme temperatures or conditions that may compromise the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Signature Care Lidocaine Cream, 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 Lidocaine Cream, 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.