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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
March 17, 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
March 17, 2017
Manufacturer
Yash Pharmaceuticals
Registration number
part348
NDC root
71301-002
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

This product is a pain-relieving crème that contains 4% lidocaine, which is a local anesthetic. It is designed to temporarily relieve minor pain, making it useful for various everyday discomforts. The crème is odor-free, providing a pleasant application experience without any strong scents.

Each bottle contains 2.7 ounces (76.5 grams) of the crème, and it is packaged with 192 bottles in a case, making it convenient for both personal use and larger needs.

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 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 product safely to avoid potential complications. You should not use it on large areas of your body, on cut, irritated, or swollen skin, or on puncture wounds. Additionally, if you find that you need to use it for more than one week, please consult your doctor.

While using this product, make sure to keep it away from your eyes, and avoid bandaging the area or applying local heat, such as heating pads. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

When using this product, it's important to apply it only to the affected area and avoid using it on large areas of skin, cuts, or swollen areas. You should not use it on puncture wounds or for more than one week without consulting a doctor. Be careful to keep it away from your eyes, and do not cover the area with bandages or apply heat.

If your condition worsens, or if symptoms last longer than seven days or return after clearing up, stop using the product and consult a doctor. If you are pregnant or breastfeeding, it's best to talk to a healthcare professional before using it. Always keep this product out of reach of children and pets, and seek immediate medical help if it is swallowed.

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 using bandages or applying heat, like heating pads, to the treated area.

If your condition worsens, or if your symptoms last longer than 7 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 act quickly. You should seek medical help immediately or contact a Poison Control Center for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to reach out for help. Remember, it's always better to be safe and get professional advice in these situations.

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 children over 12 years and adults, you can apply a thin layer of the medication to the affected area every 6 to 8 hours. However, be sure not to exceed three applications in a 24-hour period to ensure safety and effectiveness. Always follow these guidelines to help keep your child safe while using this treatment.

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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 provide the best care tailored to your needs.

Always feel free to ask questions about how different medications might affect each other or any tests you may undergo. Your health and safety are the top priority, and discussing these details can help prevent any unforeseen issues.

Storage and Handling

To ensure the best use of your product, store it at room temperature. It's important to keep the cap tightly closed between uses to maintain its effectiveness and safety. Additionally, please make sure to keep the product out of reach of children and pets to prevent any accidental ingestion or misuse. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should use this medication only on the skin (topically). 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 treating a child under 12, consult a doctor first.

Remember, this product is for external use only. Avoid using it on 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 7 days, or if symptoms return shortly after clearing up, consult a doctor. Pregnant or breastfeeding individuals should also seek advice from a healthcare professional before use. Keep this medication out of reach of children and pets, and if swallowed, seek medical help immediately.

FAQ

What is the main use of this product?

This product is a pain-relieving crème that temporarily relieves minor pain.

How should I apply this product?

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 this product?

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

Are there any warnings I should be aware of?

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

Is this product safe to use during pregnancy or breastfeeding?

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

What precautions should I take when using this product?

Do not allow contact with the eyes, do not bandage or apply local heat to the area of use, and keep it out of reach of children and pets.

What should I do if this product is swallowed?

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

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 is formulated with 4% lidocaine and is characterized by its odor-free formulation. Each bottle contains a net weight of 2.7 oz (76.5 g). The product is packaged with 192 bottles per case, ensuring ample supply for clinical or therapeutic 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 advised to consult a physician before use.

Contraindications

Use of this product is contraindicated in the following situations:

Application on large areas of the body or on cut, irritated, or swollen skin is not recommended due to the potential for increased absorption and adverse effects. It should not be applied to puncture wounds, as this may lead to complications or infection. Prolonged use beyond one week without consulting a healthcare professional is contraindicated to prevent potential systemic effects.

Additionally, during use, contact with the eyes must be avoided to prevent irritation or injury. Bandaging or the application of local heat, such as heating pads, to the treated area is also contraindicated, as this may enhance absorption and increase the risk of adverse reactions.

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 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 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 health professional prior to use. Additionally, this product should be kept out of reach of children and pets. In the event of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

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.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 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 should include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to address any complications that may arise.

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 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.

When using this product, patients should be instructed to use it only as directed and to read and follow all directions and warnings on the carton carefully. Additionally, patients 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 includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity and effectiveness.

To ensure optimal preservation, the cap must be closed tightly between uses. Additionally, it is crucial to keep the product out of reach of children and pets to prevent accidental ingestion or misuse.

Additional Clinical Information

The medication 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 refrain from using the medication for more than one week without consulting a doctor and should avoid contact with the eyes. Additionally, bandaging or applying local heat to the treated area is not recommended. Patients are advised to discontinue use and seek medical advice if their condition worsens or if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days. Pregnant or breastfeeding individuals should consult a healthcare professional before use. The product should be kept out of reach of children and pets, and in the event of ingestion, 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.

Learn more in our Editorial Policy

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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.