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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
September 14, 2017
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
September 14, 2017
Manufacturer
Velocity Pharma LLC
Registration number
part348
NDC root
76168-201
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

Care One is a pain-relieving crème designed to provide temporary relief from minor pain. It contains 4% lidocaine, which is a local anesthetic that works by blocking nerve signals in the body, helping to alleviate discomfort. This crème is odor-free and formulated for maximum strength, making it a convenient option for those seeking quick pain relief.

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, making it a safer option for those who may be concerned about such risks.

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 apply it more than three times in a 24-hour period to avoid any potential issues.

For children who are 12 years old or younger, it’s important to consult a doctor before using this medication. They can provide guidance on the appropriate use and dosage for younger patients. Always follow these instructions carefully to ensure safe and effective treatment.

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

This product is intended for external use only. You should avoid using it on large areas of your body, on cut or irritated skin, or on puncture wounds. It's important not to use it for more than one week without consulting your doctor. While using the product, make sure to follow all directions carefully, avoid contact with your eyes, and do not apply heat or bandage the area.

If your condition worsens, or if symptoms last longer than seven days or return after clearing up, stop using the product and consult your doctor. If you are pregnant or breastfeeding, please speak with a healthcare professional before use. Keep this product out of reach of children and pets, and if swallowed, seek medical help or contact a Poison Control Center 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 get checked by a medical professional 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

Before using this medication for children aged 12 years and younger, it's important to consult with a doctor. For those over 12, you can apply a thin layer to the affected area every 6 to 8 hours, but be sure not to exceed three applications in a 24-hour period.

Always keep this medication out of reach of children and pets. If it is accidentally swallowed, seek medical help or contact a Poison Control Center immediately. Your child's safety is a priority, so following these guidelines is essential.

Geriatric Use

While there is no specific information about the use of Lidocaine Pain Relieving Cream in older adults, it’s important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this product. They can provide personalized advice based on your health status and any other medications you may be taking.

Always prioritize safety and ensure that any treatment aligns with your individual health needs, especially if you are caring for an older adult.

Renal Impairment

If you have kidney problems, 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 change based on renal impairment. However, it’s always best to discuss your individual situation with your healthcare provider, as they can offer personalized advice and monitor your health closely.

Make sure to keep your doctor informed about your kidney health, as they may need to adjust your treatment plan based on your overall condition and any other medications you may be taking.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medications or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

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 use this medication only on the skin and follow the instructions carefully. For adults and children over 12 years, apply a thin layer to the affected area every 6 to 8 hours, but do not exceed three applications in a 24-hour period. If you are using it for a child under 12, consult a doctor first.

Remember, this product is for external use only. Avoid applying it to large areas, on broken or irritated skin, or on puncture wounds. Do not cover the area with bandages or apply heat, and keep it away from your eyes. If your condition worsens or does not improve after a week, contact your doctor. If you are pregnant or breastfeeding, check with a healthcare professional before use. Always keep this medication out of reach of children and pets, and seek medical help immediately if swallowed.

FAQ

What is Care One?

Care One is a pain-relieving crème that is odor-free and contains 4% lidocaine, providing maximum strength for temporary relief of minor pain.

How should I use Care One?

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. For children 12 years and younger, consult a doctor.

Are there any warnings for using Care One?

Yes, it is for external use only. Avoid contact with eyes, do not bandage or apply local heat to the area, 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 Care One?

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

Can I use Care One if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using Care One.

What should I do if Care One is swallowed?

If swallowed, seek medical help or contact a Poison Control Center immediately.

Is there any information on drug interactions with Care One?

No specific drug interactions are mentioned for Care One.

What are the storage instructions for Care One?

Close the cap tightly between uses and keep it out of reach of children and pets.

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

This pain-relieving crème contains 4% lidocaine, providing maximum strength for effective relief. The formulation is odor-free, ensuring a neutral application experience. Careone Lidocaine is presented in a 4.7 oz container, designed for topical use.

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 recommended to consult a physician prior to 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.

If the condition worsens or if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days, the user should discontinue use and seek medical advice.

This product must 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.

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. The product 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 should not bandage or apply local heat, such as heating pads, to the area of use.

Patients are advised to discontinue use and consult a doctor if the 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. Additionally, the product should be kept 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 should be made.

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 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 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 ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

Geriatric Use

There is no specific information regarding the use of Lidocaine Pain Relieving Creme 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 efficacy and potential adverse effects is recommended in this population, given the lack of targeted clinical findings for geriatric use.

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 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 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 event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention 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 course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution 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 these contexts.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

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 counsel patients against using the product for more than one week without consulting a doctor.

Healthcare providers should emphasize that patients must 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.

Patients should be reminded to use the product only as directed and to read and follow all directions and warnings on the carton carefully. Additionally, they should be cautioned to avoid contact with the eyes and 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 that 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 are instructed to use the product as directed, adhering to all warnings and directions on the packaging. They should avoid contact with the eyes and refrain from bandaging or applying local heat to the treated area. If symptoms worsen or persist beyond 7 days, or if they resolve and recur shortly thereafter, patients should seek medical advice. Pregnant or breastfeeding individuals should consult a healthcare professional before use. Additionally, the product should be kept out of reach of children and pets, and immediate medical assistance should be sought if ingested.

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.