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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 2017
Label revision date
July 25, 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
July 25, 2018
Manufacturer
Topco
Registration number
part348
NDC root
36800-740
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 and itching caused by minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritation. It is designed to help soothe discomfort and promote healing for these common skin issues. If you experience any of these conditions, this drug may provide the relief you need.

Uses

You can use this medication for temporary relief from pain and itching caused by minor burns, sunburn, minor cuts, scrapes, insect bites, or other minor skin irritations. It’s designed to help soothe discomfort and promote healing in these common skin issues.

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 concerned about such risks.

Dosage and Administration

If you or your child is 2 years of age or 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. However, if your child is under 2 years old, it’s important to consult a doctor before using the medication. This will help ensure safety and proper care for younger children.

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 associated with this product. However, always use it 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 remember that it is for external use only. Avoid getting it in your eyes and do not apply it in large amounts, especially on raw or blistered skin. If your condition worsens, or if symptoms persist for more than 7 days or return shortly after improvement, stop using the product and consult a doctor.

In case the product is swallowed, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid getting it in your eyes. It's important not to apply it in large amounts, especially on raw or blistered skin.

If your condition worsens, or if your symptoms last longer than 7 days or return after clearing up, stop using the product and consult your doctor. Additionally, if you accidentally swallow the product, 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 managing the situation effectively.

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 professional assistance. Remember, your safety and well-being are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of lidocaine HCl cream during pregnancy has not been established. This means that its use is not generally recommended unless your healthcare provider believes that the benefits outweigh any potential risks to your baby. There may be risks associated with using this cream, so it's essential to consult with your healthcare provider for personalized advice.

Additionally, if you do use lidocaine HCl cream while pregnant, your doctor may suggest adjustments to the dosage to ensure safety. Always seek guidance from your healthcare provider to make informed decisions about your health and the health of your baby.

Lactation Use

If you are breastfeeding, you can use lidocaine HCl cream without specific warnings or recommendations against it. The information available does not indicate any particular concerns or precautions for nursing mothers regarding this cream.

As always, if you have any questions or concerns about using medications while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children aged 2 years and older, you can apply the medication to the affected area, but be sure not to exceed 3 to 4 applications per day. Always follow these guidelines to ensure your child's safety and well-being.

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 guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider for personalized advice and recommendations.

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.

However, it's always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can provide personalized advice and ensure that your treatment is safe and effective based on your individual health needs.

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 medication 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 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 acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the ideal range. 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, as it should not be reused. Following these guidelines will help maintain the safety and effectiveness of your product.

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 patient counseling.

FAQ

What is the drug used for?

The drug provides temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritation.

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?

There are no specific contraindications 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 while using this drug?

This product is for external use only. Avoid contact with eyes and do not use in large quantities, especially over raw surfaces or blistered areas.

When should I stop using this drug?

Stop use and ask a doctor if the 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 safety of this drug during pregnancy has not been established. Consult a healthcare provider for advice, as there may be risks to the fetus.

What are the storage conditions for this drug?

Store at 20°C to 25°C (68°F to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light and keep the container tightly closed.

Packaging Info

Below are the non-prescription pack sizes of Pain Relief (lidocaine hcl). 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

No specific information related to the Description section for SPL code 34089-3 is provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritation.

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 properly prepared 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 avoid contact with the eyes during application. It is crucial to instruct patients not to use the product in large quantities, especially over raw surfaces or blistered areas, to prevent potential adverse effects.

Patients should be advised 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. These actions are essential to ensure appropriate management of the patient's condition.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay. This precaution is vital to mitigate any potential risks associated with ingestion of the product.

Side Effects

Patients using this product should be aware that it is for external use only. It is important to avoid contact with the eyes and to refrain from using the product in large quantities, especially 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 stop use and consult a doctor.

Additionally, if the product is swallowed, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

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). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Relief.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

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 lack of targeted data for this population.

Pregnancy

The safety of lidocaine HCl cream during pregnancy has not been established. The use of this medication is not recommended in pregnant women unless the potential benefits justify the potential risks to the fetus. There may be risks associated with the use of lidocaine HCl cream during pregnancy; therefore, it is essential for healthcare providers to be consulted for advice regarding its use.

Dosage adjustments may be necessary for pregnant women, and specific recommendations should be obtained from a healthcare provider to ensure the safety and well-being of both the mother and the fetus.

Lactation

Lidocaine HCl cream has not been associated with specific warnings or recommendations for use in nursing mothers. Additionally, there are no particular considerations or precautions related to lactation or breastfeeding noted in the available information. Therefore, healthcare professionals may consider the use of lidocaine HCl cream in lactating mothers without specific concerns regarding its effects on 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 are no established 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. 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 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 of overdosage should be guided by the severity of symptoms and the clinical judgment of the healthcare provider. It is imperative to monitor the patient closely and provide supportive care as necessary.

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 the product out of reach of children to prevent accidental ingestion. It is important to emphasize that if the product is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This information is crucial for ensuring the safety and well-being of patients and their families.

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 prevent degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

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, consultation with a doctor is advised prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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.