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Pain Relief Cream

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 3.86 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 2019
Label revision date
January 5, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 3.86 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 2019
Label revision date
January 5, 2021
Manufacturer
AEC Consumer Products
Registration number
part348
NDC root
86089-222
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

You can use this medication for the temporary relief of pain. It is designed to help alleviate discomfort, making it easier for you to manage your daily activities. If you're experiencing pain, this drug may provide the relief you need to feel more comfortable.

Uses

You can use this medication for the temporary relief of pain. It is designed to help alleviate discomfort, making it easier for you to go about your daily activities.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

You should apply the medication to the affected areas of your skin as needed. It's important to do this 3 to 4 times a day to ensure the best results. Make sure to follow this schedule consistently for effective relief.

What to Avoid

It's important to use this product safely to avoid potential complications. Do not use it in large quantities, especially on raw or blistered skin, for more than one week without consulting your doctor. When applying the product, be careful to avoid contact with your eyes, as this can cause irritation. Additionally, do not cover the treated area with a bandage or apply local heat, such as heating pads, as this may lead to unwanted effects.

Remember, using this product improperly can lead to issues like dependence (a condition where your body becomes reliant on a substance) or misuse. Always follow these guidelines to ensure your safety and well-being.

Side Effects

It's important to be aware of potential side effects when using this product. You should stop using it and consult a doctor if your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days.

Remember, this product is for external use only. If you have any concerns about your symptoms or how the product is affecting you, don't hesitate to reach out to a healthcare professional for guidance.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. Keep it out of reach of children, and if it is accidentally ingested, seek medical help or contact a Poison Control Center immediately. Be cautious not to use large amounts, especially on raw or blistered skin, for more than a week without consulting your doctor.

If your condition worsens or if symptoms last longer than seven days, stop using the product and reach out to your doctor. Additionally, if your symptoms improve but then return within a few days, you should also stop using it and consult your doctor for further advice.

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. Remember, timely intervention can make a significant difference.

Pregnancy Use

It's important to be cautious when using this medication during pregnancy. You should avoid using it in large amounts, especially on raw or blistered skin, and for more than one week without consulting your doctor. This is to ensure your safety and the safety of your developing baby.

Additionally, keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. Taking these precautions can help protect both you and your child during this sensitive time.

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 it may pose to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It’s important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

For adults and children over 12 years old, the medication can be applied to the affected areas 3 to 4 times a day as needed. If pain continues, it’s best to consult a physician. Always ensure that younger children do not have access to this product to prevent any accidental ingestion.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

You can feel confident that there are no specific storage or handling instructions for this product or device. This means you can store it in a standard environment without worrying about special conditions.

For safety, always handle the product with clean hands and ensure that any surfaces you use are clean. If you have any questions about proper use or safety, don’t hesitate to reach out for more information.

Additional Information

You should apply the medication to the affected areas 3-4 times a day as needed. If your condition worsens or if symptoms last more than 7 days, stop using the product and consult a doctor. Additionally, if your symptoms improve and then return within a few days, you should also seek medical advice.

Make sure to keep the medication out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is the primary use of this drug?

This drug is used for the temporary relief of pain.

How should I apply this drug?

You should apply it as needed to affected areas 3-4 times a day.

What should I do if my pain persists?

Consult a physician if your pain persists.

Are there any warnings for using this drug?

Yes, it is for external use only, and you should avoid contact with the eyes.

What should I do if I experience worsening symptoms?

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

Can I use this drug on raw or blistered surfaces?

No, do not use it in large quantities over raw or blistered surfaces for more than one week without consulting a doctor.

What should I do if this drug is swallowed?

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

Is this drug safe for children?

Keep it out of reach of children, and consult a doctor if it is swallowed.

Are there any specific precautions for nursing mothers?

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

Is there any information on drug interactions?

No specific drug interactions are mentioned in the insert.

Packaging Info

Below are the non-prescription pack sizes of Pain Relief Cream (lidocream hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Relief Cream.
Details

Drug Information (PDF)

This file contains official product information for Pain Relief Cream, 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. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of pain.

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

Dosage and Administration

Healthcare professionals are advised to apply the medication to the affected areas as needed, with a recommended frequency of 3 to 4 times per day. Care should be taken to ensure that the application is thorough and covers the entire affected area to maximize therapeutic efficacy.

Contraindications

The product should not be used in large quantities, particularly over raw or blistered surfaces, for more than one week without consulting a doctor.

Contact with the eyes must be avoided to prevent irritation or injury. Additionally, do not bandage or apply local heat, such as heating pads, to the area of use, as this may exacerbate irritation or lead to adverse effects.

Warnings and Precautions

For external use only. This product is not intended for internal use, and caution should be exercised to prevent accidental ingestion.

It is imperative to keep this product out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

General precautions should be observed when using this product. It is advised not to apply it in large quantities, especially over raw or blistered surfaces, and usage should not exceed one week without prior consultation with a healthcare professional.

Healthcare providers should instruct patients to discontinue use and seek medical advice if the condition worsens or if symptoms persist beyond 7 days. Additionally, if symptoms resolve and then recur within a few days, patients should also stop using the product and consult a doctor.

In cases of accidental ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately.

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. It is advised that patients seek medical advice under these circumstances to ensure appropriate management and care.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. 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 Pain Relief Cream (lidocream hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Relief Cream.
Details

Pediatric Use

Pediatric patients should not use this medication. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

For adults and children over 12 years of age, the recommended application is to affected areas 3-4 times daily. If pain persists, consultation with a physician is necessary.

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 should be advised against the use of this product in large quantities, particularly over raw or blistered surfaces, for more than one week without consulting a healthcare professional. The potential risks associated with excessive use during pregnancy have not been fully established, and caution is warranted to avoid any adverse effects on fetal outcomes.

Additionally, this product should be kept out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended. Healthcare providers should ensure that pregnant patients are aware of these precautions to mitigate any potential risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion 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

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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management and follow-up care.

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 potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be informed not to use this product in large quantities, especially over raw or blistered surfaces, for more than one week without consulting a healthcare professional. It is important to instruct patients to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than seven days. Additionally, patients should be advised to stop using the product and seek medical advice if symptoms resolve but then reoccur within a few days.

When using this product, patients must be reminded to follow the directions carefully. They should avoid contact with the eyes and should not bandage or apply local heat, such as heating pads, to the area of application.

Storage and Handling

The product is available in various package configurations, with specific NDC numbers assigned for identification. Storage and handling instructions are not explicitly provided; therefore, standard practices for pharmaceutical products should be followed. It is advisable to store the product in a controlled environment, ensuring that it is kept at appropriate temperature ranges to maintain its integrity. Containers should be secure and suitable for the product type to prevent contamination or degradation. Special handling requirements are not specified, but general precautions should be taken to ensure the product's safety and efficacy during storage and transportation.

Additional Clinical Information

Patients should apply the medication to affected areas as needed, with a recommended frequency of 3-4 times a day. Clinicians should advise patients to discontinue use and consult a doctor if the condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, patients should also seek medical advice.

It is important for patients to keep the medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

Drug Information (PDF)

This file contains official product information for Pain Relief 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 Pain Relief 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.