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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
September 14, 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
September 14, 2017
Manufacturer
Yash Pharmaceuticals
Registration number
part348
NDC root
71301-006
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 medication commonly used to numb specific areas of the body. It is designed to temporarily relieve minor pain, making it useful for various discomforts you may experience. The crème is odor-free and comes in a 2.7 oz (76.5 g) bottle, providing a convenient option for pain management.

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 apply it more than three times in a 24-hour period to avoid any potential issues.

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

It's important to use this medication safely to avoid potential issues. You should not apply it to large areas of your body or on skin that is cut, irritated, or swollen. Additionally, avoid using it on puncture wounds. If you find that you need to use this medication for more than one week, please consult your doctor for guidance. Following these instructions will help ensure your safety and the effectiveness of the treatment.

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. 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. Additionally, do not cover the treated area with bandages or apply heat, such as heating pads.

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. It's also important to keep this product out of reach of children. If 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 seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

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 product to the affected area every 6 to 8 hours. However, be sure not to exceed three applications within a 24-hour period to ensure safety and effectiveness. Always follow these guidelines to help protect your child's health.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.

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 your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition 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 may affect you if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual 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 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

To ensure the best use of your product, store it at room temperature and always close the cap tightly after each use. This helps maintain its effectiveness and safety. It's important to keep the product out of reach of children and pets to prevent any accidental ingestion or misuse.

Once you open the product, remember to discard it after use to avoid any potential risks associated with prolonged exposure. Following these simple guidelines will help you handle the product safely and effectively.

Additional Information

You should apply a thin layer of the medication to the affected area every 6 to 8 hours, but do not exceed three applications in a 24-hour period if you are an adult or a child over 12 years old. For children under 12, consult a doctor before use.

If you are pregnant or breastfeeding, it's important to talk to a health professional before using this medication. Always keep it out of reach of children and pets, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is the main use of this product?

This product 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?

This product is for external use only. Avoid contact with eyes and do not bandage or apply local heat to the area of use.

What should I do if my condition worsens?

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

Is it safe to use this product if I am pregnant or breastfeeding?

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

What should I do if this product is swallowed?

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

Are there any contraindications for this product?

There are no specific contraindications mentioned, but do not use on large areas of the body, on cut or irritated skin, or for more than one week without consulting a doctor.

How should I store this product?

Store at room temperature, close the cap tightly between uses, and keep out of reach of children and pets.

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 contains 4% lidocaine and is formulated to be odor-free. Each bottle has 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 recommended to consult a physician prior to use.

Contraindications

The product is contraindicated for use on large areas of the body or on cut, irritated, or swollen skin due to the potential for adverse effects. Additionally, it should not be applied to puncture wounds. Prolonged use beyond one week without consulting a healthcare professional is also contraindicated to ensure safety and efficacy.

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 using this product should be aware that it 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.

During use, it is essential to adhere strictly to the provided directions and warnings. Patients should avoid contact with the eyes and refrain from bandaging or applying local heat, such as heating pads, to the area of application.

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. Additionally, pregnant or breastfeeding individuals should seek advice from a healthcare professional prior to use.

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 without delay.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 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 prior to 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 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals 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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs. Allergic reactions have been noted, including manifestations such as rash, itching, and hives. Additionally, systemic reactions have been observed, which include symptoms like dizziness, drowsiness, and confusion.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children and pets to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately.

It is essential for patients to use the medication only as directed. They should be encouraged to read and follow all directions and warnings provided on the carton to ensure safe and effective use.

Healthcare providers should also inform patients to avoid contact with the eyes, as this could lead to irritation or injury. Additionally, patients should be cautioned against bandaging or applying local heat, such as heating pads, to the area of use, as this may exacerbate side effects or interfere with the medication's effectiveness.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at room temperature, ensuring that the cap is closed tightly between uses to maintain product integrity. It is essential to keep the product out of reach of children and pets to prevent accidental ingestion. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically. For adults and children over 12 years, a thin layer should be applied to the affected area every 6 to 8 hours, with a maximum of three applications within a 24-hour period. For children aged 12 years and younger, it is advised to consult a doctor before use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the product out of reach of children and pets. In the event of ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

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.