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Pain Relief

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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 2015
Label revision date
February 19, 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 2015
Label revision date
February 19, 2018
Manufacturer
Walgreens
Registration number
part348
NDC root
0363-3178
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 minor pain associated with various conditions, including arthritis, simple backaches, muscle strains, and bruises. It works by targeting the discomfort you may feel in these areas, helping you to manage your pain effectively.

Uses

If you're dealing with minor pain from conditions like arthritis, simple backaches, muscle strains, or bruises, this medication can provide temporary relief. It's designed to help ease discomfort so you can go about your daily activities with less pain.

Rest assured, there are no concerns about teratogenic effects (which means it won't cause birth defects) associated with this medication. This makes it a safer option for those who may be pregnant or planning to become 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 using this medication. They can provide the best advice tailored to your child's needs. Always remember to use the medication as directed for safety and effectiveness.

What to Avoid

It's important to be aware of specific instructions regarding the use of this product. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately. This is crucial for your safety.

Currently, there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence (a condition where your body becomes reliant on a substance). However, always use the product as directed and consult with a healthcare professional if you have any questions or concerns.

Side Effects

When using this product, it's important to follow the directions carefully. It is meant for external use only, so avoid applying it to wounds or damaged skin, and do not use it in large amounts, especially on raw or blistered areas. Be cautious to keep it away from your eyes and do not bandage the area tightly. If your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days, stop using the product and consult a doctor.

Keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please follow the instructions carefully. Avoid using it on wounds or damaged skin, and do not apply it tightly bandaged. Make sure to keep it away from your eyes and avoid using large amounts, especially on raw or blistered areas.

If your condition worsens, or if your symptoms last more than 7 days or return after clearing up, stop using the product and consult your doctor. Additionally, if the product is swallowed, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed this product, it’s important to seek medical help immediately or contact a Poison Control Center. Acting quickly can make a significant difference in ensuring safety and proper care.

Signs of an overdose may include unusual symptoms, but specific details about these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, your health and safety are the top priority, so always err on the side of caution.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific guidelines or safety concerns mentioned regarding the use of Lidocaine HCl 4% cream during pregnancy. The information available does not indicate any contraindications (situations where the product should not be used) or special precautions for pregnant individuals. Additionally, there are no recommended dosage modifications for those who are pregnant.

As always, it's best to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby.

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 no more than 3 to 4 times a day. However, if your child is under 2 years old, it’s important to consult a doctor before use. Always remember to keep the medication out of reach of children to ensure their safety.

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 considering this medication, it’s important to consult with a healthcare provider. 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

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no dosage adjustments, special monitoring, or safety considerations to discuss for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to consult your healthcare provider for personalized advice and guidance. They can provide you with the necessary information tailored to your specific situation.

Hepatic Impairment

If you have liver 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 apply, and there are no special monitoring or precautions outlined for patients like you.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your liver health. They can provide guidance 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 may not have known conflicts with other drugs or 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 upcoming lab tests with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C and 25°C (68°F to 77°F). It’s okay for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the recommended limits. Make sure to protect the product from light and always keep the container tightly closed when not in use.

Once you open the container, remember to discard any remaining product to maintain safety and effectiveness. Following these guidelines 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. There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What minor pains does this drug relieve?

This drug provides temporary relief of minor pain associated with arthritis, simple backache, muscle strains, and bruises.

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. Consult a doctor for children under 2 years of age.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What should I do if the product is swallowed?

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

What precautions should I take when using this product?

Use only as directed, avoid contact with eyes, do not apply to wounds or damaged skin, and do not use in large quantities over raw surfaces or blistered areas.

What should I do if my condition worsens?

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

Is this drug safe to use during pregnancy?

The insert does not mention any specific safety concerns or precautions regarding the use of this product during pregnancy.

Can nursing mothers use this product?

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

How should I store this drug?

Store at 20°C to 25°C (68°F to 77°F), protect from light, and keep the container tightly closed. Discard after opening.

Packaging Info

Below are the non-prescription pack sizes of Pain Relief (lidocaine hcl 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Relief.
Details

Drug Information (PDF)

This file contains official product information for Pain Relief, 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 minor pain associated with various conditions, including arthritis, simple backache, muscle strains, and bruises.

Limitations of Use: 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 clean and dry prior to administration.

For children under 2 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

The product is intended for external use only. Healthcare professionals should advise patients to adhere strictly to the directions provided for use. It is imperative to avoid bandaging the area tightly, as this may lead to complications. Care should be taken to prevent contact with the eyes, and the product must not be applied to wounds or damaged skin. Additionally, patients should be cautioned against using the product in large quantities, especially over raw surfaces or blistered areas, to minimize the risk of adverse effects.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients should be aware that this product is for external use only. It is essential to use the product strictly as directed, avoiding tight bandaging, contact with the eyes, and application to wounds or damaged skin. Additionally, the product should not be used in large quantities, particularly over raw surfaces or blistered areas.

In the event that the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, patients are advised to discontinue use and consult a healthcare professional.

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

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and 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 Pain Relief (lidocaine hcl 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Relief.
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 prior to use. Additionally, the product should be kept out of reach of children to ensure safety.

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

There are no specific statements regarding the use of Lidocaine HCl 4% cream during pregnancy. The available prescribing information does not mention any safety concerns, contraindications, or special precautions associated with the use of this product in pregnant patients. Additionally, no dosage modifications for pregnant individuals are provided. Healthcare professionals should consider the absence of data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks.

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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

Overdosage

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

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific product and the amount ingested; therefore, a thorough assessment by a medical professional is recommended.

Management procedures will typically involve supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that if the product is swallowed, it is crucial to seek medical help immediately or contact a Poison Control Center. This information is essential for ensuring patient safety and prompt action in case of accidental ingestion.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to ensure its stability. Once opened, the product should be discarded to prevent any potential degradation or contamination.

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 prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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