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Lidocaine Pain Relieving Creme

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 4 g/100 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 2017
Label revision date
May 18, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 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 2017
Label revision date
May 18, 2018
Manufacturer
Velocity Pharma LLC
Registration number
part348
NDC root
76168-205
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

Careone Lidocaine is a topical medication designed to temporarily relieve minor pain. It contains lidocaine, which works by numbing the area where it is applied, helping to alleviate discomfort from various sources. This product is typically used for minor aches and pains, providing a soothing effect to help you feel more comfortable.

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) associated with this medication.

Dosage and Administration

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

For children who are 12 years old or younger, it’s important to consult a doctor before using this medication. This ensures that the treatment is safe and appropriate for their specific needs. Always follow these guidelines to help manage your condition effectively.

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 skin that is cut, irritated, or swollen. Additionally, avoid using it on puncture wounds. If you find that you need to use this medication for more than one week, please consult your doctor for guidance. Following these instructions will help ensure your safety and the effectiveness of the treatment.

Side Effects

When using this product, it's important to be aware of some potential side effects and precautions. You should only apply it externally and avoid using it on large areas of your body, on cut or irritated skin, or on puncture wounds. If your condition worsens, persists for more than seven days, or returns shortly after improvement, stop using the product and consult a doctor.

Additionally, take care to prevent contact with your eyes, and do not apply heat or bandage the treated area. If you are pregnant or breastfeeding, it's best to consult a healthcare professional before use. Always keep the product out of reach of children, and if swallowed, seek medical help immediately.

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. Avoid bandaging the area or applying heat, like heating pads, to the treated area.

If your condition worsens, or if your symptoms last longer than seven days or return after clearing up, stop using the product and contact your doctor. Additionally, keep this product out of reach of children. If it is swallowed, seek medical help or contact a 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 a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

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, it’s always better to be safe and seek assistance if you suspect an overdose.

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 you have a child who is 12 years old or younger, it's important to consult with a doctor before using this medication. For those over 12, you can apply a thin layer to the affected area every 6 to 8 hours, but be careful not to exceed three applications in a 24-hour period.

Always keep this medication out of reach of children and pets. If your child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

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 before starting the medication. 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 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 may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any concerns you may have regarding your medications or tests. Your safety and well-being are the top priorities, and clear communication is key to achieving the best outcomes.

Storage and Handling

To ensure the safety and effectiveness of your product, always close the cap tightly after each use. This helps prevent contamination and maintains the integrity of the contents. Additionally, it's important to keep the product out of reach of children and pets to avoid any accidental ingestion or misuse.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your use.

Additional Information

You should apply this medication topically, using a thin layer on the affected area every 6 to 8 hours, but no more than three times in a 24-hour period. If you are treating a child under 12 years old, consult a doctor first. Remember, this product is for external use only—do not apply it to large areas, on broken or irritated skin, or on puncture wounds.

It's important to follow all directions and warnings on the packaging. Avoid contact with your eyes, and do not use bandages or heating pads on the treated area. If your condition worsens or does not improve after a week, consult a doctor. If you are pregnant or breastfeeding, check with a healthcare professional before use. Keep this medication out of reach of children and pets, and seek medical help immediately if swallowed.

FAQ

What is Careone Lidocaine used for?

Careone Lidocaine is used to temporarily relieve minor pain.

How should I apply Careone Lidocaine?

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 use Careone Lidocaine?

Children 12 years and younger should ask a doctor before use.

Are there any warnings for using Careone Lidocaine?

Yes, it is for external use only. Do not use on large areas of the body, on cut or irritated skin, or for more than one week without consulting a doctor.

What should I do if I experience worsening symptoms?

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

Is Careone Lidocaine safe to use during pregnancy or breastfeeding?

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

What should I do if Careone Lidocaine is swallowed?

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

What precautions should I take when using Careone Lidocaine?

Do not allow contact with the eyes, do not bandage or apply local heat to the area of use, and always use as directed.

Packaging Info

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

Packaging configurations for Lidocaine Pain Relieving Creme.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Careone Lidocaine is a topical formulation containing lidocaine as the active ingredient. It is presented in a 4.7-ounce dosage form. The product is designed for local anesthetic use, providing temporary relief from pain and discomfort. The formulation is intended for application to the skin, where it acts to numb the area and alleviate sensations of pain.

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 12 years and younger, it is advised to consult a physician before use.

Contraindications

The product is contraindicated for use on large areas of the body or on cut, irritated, or swollen skin due to the potential for adverse effects. Additionally, it should not be applied to puncture wounds. Prolonged use beyond one week without consulting a healthcare professional is also contraindicated to ensure safety and efficacy.

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 beyond seven days, or if symptoms resolve and then recur within a few days.

This product should be kept out of reach of children. In the event of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients should be aware that this product is intended 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, the product should not be used for more than one week without consulting a healthcare professional.

During the use of this product, patients should avoid contact with the eyes and should not bandage or apply local heat, such as heating pads, to the area of application.

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.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a healthcare professional prior to use.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

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 the current information.

Packaging & NDC

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

Packaging configurations for Lidocaine Pain Relieving Creme.
Details

Pediatric Use

Pediatric patients 12 years and younger should be advised to consult a healthcare professional before use. For adolescents and adults over 12 years, the recommended application is a thin layer to the affected area every 6 to 8 hours, with a maximum of 3 applications within a 24-hour period.

It is essential to keep the product out of reach of children and pets. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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 adverse effects or changes in therapeutic response, given the potential for altered pharmacokinetics and pharmacodynamics 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication 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.

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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 these contexts.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs. Allergic reactions have been noted, including manifestations such as rash, itching, and hives. Additionally, systemic reactions have been observed, which include symptoms such as dizziness, drowsiness, and confusion.

Patient Counseling

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

Patients should be informed not to use the product on large areas of the body or on cut, irritated, or swollen skin, and it should not be applied to puncture wounds. It is important to emphasize that the product should not be used for more than one week without consulting a doctor.

Healthcare providers should counsel patients to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Patients must be reminded to use the product only as directed and to read and follow all directions and warnings on the carton carefully.

Additionally, patients should be cautioned against allowing the product to come into contact with their eyes. They should also be advised not to bandage or apply local heat, such as heating pads, to the area of use.

Storage and Handling

The product is supplied in a configuration that ensures optimal safety and efficacy. It is essential to close the cap tightly between uses to maintain the integrity of the product.

For storage, the product should be kept out of reach of children and pets to prevent accidental ingestion or misuse. Proper handling and storage conditions are crucial to ensure the product remains effective and safe for use.

Additional Clinical Information

The product is administered topically, with a recommended application of a thin layer to the affected area every 6 to 8 hours for adults and children over 12 years, not exceeding three applications within a 24-hour period. For children aged 12 years and younger, consultation with a doctor is advised prior to use.

Clinicians should counsel patients on the following precautions: the product is for external use only and should not be applied to large areas of the body, cut, irritated, or swollen skin, or puncture wounds. Patients should not use the product for more than one week without consulting a doctor. It is essential to follow all directions and warnings on the packaging, avoid contact with the eyes, and refrain from bandaging or applying local heat to the treated area. Patients should discontinue use and seek medical advice if their condition worsens or if symptoms persist beyond 7 days or recur shortly after improvement. Pregnant or breastfeeding individuals should consult a healthcare professional before use, and the product should be kept out of reach of children and pets. In case of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Lidocaine Pain Relieving Creme, 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 Lidocaine Pain Relieving Creme, 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.

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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.