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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
May 31, 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
May 31, 2018
Manufacturer
SOTAC PHARMACEUTICALS PRIVATE LIMITED
Registration number
part348
NDC root
72351-004
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

Lido cream is a topical medication that is used to temporarily relieve minor pain. It works by numbing the area where it is applied, helping to reduce discomfort from various conditions. This makes it a helpful option for managing pain in specific areas of the skin.

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.

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. 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

You should avoid using this medication on large areas of your body or on skin that is cut, irritated, or swollen. It’s also important not to apply it to puncture wounds. If you need to use it for more than one week, please consult your doctor first.

Additionally, make sure to keep the medication away from your eyes, and do not cover the treated area with bandages or apply local heat, such as heating pads. Following these guidelines will help ensure your safety while using this product.

Side Effects

When using this product, it's important to be aware of potential side effects. You should only apply it to the skin as directed and avoid using it on large areas, cut or irritated skin, or puncture wounds. If your condition worsens, persists for more than seven days, or returns after improvement, stop using the product and consult a doctor.

Additionally, if you are pregnant or breastfeeding, it's best to consult a healthcare professional before use. Always keep the product out of reach of children, and if swallowed, seek medical help immediately or contact a Poison Control Center.

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 area where you apply the product.

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 a medication and you suspect an overdose, it’s important to act quickly. Contact a medical professional or call a Poison Control Center immediately for assistance. They can provide guidance on what to do next.

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 seek immediate medical help. Your safety is the top priority, so getting prompt assistance is crucial.

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 and any medications you may consider.

Pediatric Use

If your child is 12 years old or younger, it's important to consult with a doctor before using this medication. For children and adults over 12 years, 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 follow these guidelines to ensure safe and effective use.

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

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help monitor your kidney function and make any necessary adjustments to 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 should be used if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective, tailored specifically to your health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This proactive approach helps prevent any potential issues and supports your overall well-being.

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 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 apply this medication topically, using a thin layer on the affected area every 6 to 8 hours. For adults and children over 12 years, do not exceed three applications in a 24-hour period. If the patient is 12 years or younger, consult a doctor before use.

Remember, this medication is for external use only. Avoid applying it to large areas, on broken or irritated skin, or on puncture wounds. Do not use it for more than a week without consulting a doctor, and always follow the directions on the packaging. Keep it away from your eyes, and do not use bandages or heating pads on the treated area. If your condition worsens or does not improve after 7 days, contact a doctor. Pregnant or breastfeeding individuals should seek advice from a healthcare professional before use. Keep this product out of reach of children and pets, and if ingested, seek medical help immediately.

FAQ

What is lido cream used for?

Lido cream is used to temporarily relieve minor pain.

How should I apply lido cream?

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 lido cream?

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

Are there any contraindications for using lido cream?

Do not use lido cream on large areas of the body, on cut, irritated, or swollen skin, or on puncture wounds. Avoid using it for more than one week without consulting a doctor.

What precautions should I take when using lido cream?

Use only as directed, avoid contact with the eyes, and do not bandage or apply local heat to the area of use.

What should I do if my condition worsens while using lido cream?

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

Is lido cream safe to use during pregnancy or breastfeeding?

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

What should I do if lido cream is swallowed?

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

How should I store lido cream?

Store lido cream at room temperature and keep the cap tightly closed between uses.

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

Lido cream is a topical formulation containing lidocaine as its active ingredient. It is designed for local anesthesia and is typically used to relieve pain and discomfort associated with various dermatological procedures. The cream appears as a smooth, white to off-white emulsion. The molecular weight of lidocaine is 234.34 g/mol, and its chemical formula is C14H22N2O. The formulation may include various inactive ingredients to enhance stability and application properties.

Uses and Indications

This drug is indicated for the temporary relief of minor pain.

There are no teratogenic effects associated with this drug, nor are there any nonteratogenic effects mentioned.

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 before use.

Contraindications

Use is contraindicated in the following situations:

Application on large areas of the body or on cut, irritated, or swollen skin is prohibited due to the potential for increased systemic absorption and adverse effects. The product 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 adverse reactions. Additionally, contact with the eyes must be avoided to prevent irritation or injury. Bandaging or applying local heat, such as heating pads, to the area of use is also contraindicated, as this may enhance absorption and increase the risk of side effects.

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.

Discontinuation of use and consultation with a healthcare provider is advised if the condition worsens, if symptoms persist beyond seven days, or if symptoms resolve and then recur within a few days.

This product should 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 is recommended.

Side Effects

Patients should be aware that this product is intended 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 provided directions and warnings. Care should be taken to avoid contact with the eyes, and the area of application should not be bandaged or subjected to local heat, such as heating pads.

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 resolve 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, this product should 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.

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 children over 12 years, the recommended dosage is to apply 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

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

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 no specific data available regarding the excretion of this medication in 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 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 use of the compound in question.

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 emphasize that the product should not be used for more than one week without consulting a doctor.

Healthcare providers should counsel patients to stop using the product and seek medical advice 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 must be reminded to use the product only as directed and to read and follow all directions and warnings on the carton carefully.

Additionally, patients should be cautioned against allowing the product to come into contact with their eyes. They should also be advised 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 usability. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Users are advised to close the cap tightly between uses to prevent contamination and preserve the quality of the product. Additionally, it is crucial to keep the product out of reach of children and pets to ensure safety during storage.

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 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 medication only as directed, adhering to all warnings and directions on the packaging. They should avoid contact with the eyes, refrain from bandaging or applying local heat to the treated area, and discontinue use if the condition worsens or symptoms persist beyond 7 days. 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.