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Pain Itch Relief

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Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2023
Label revision date
December 20, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2023
Label revision date
December 20, 2024
Manufacturer
Trifecta Pharmaceutical USA LLC
Registration number
M017
NDC root
69396-120
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

Globe Lidocaine Cream is a topical medication that contains lidocaine, which is used to temporarily relieve minor pain. This cream is applied directly to the skin, where it works by numbing the area to help alleviate discomfort. It is commonly used for various minor aches and pains, providing a soothing effect when you need it most.

Uses

You can use this medication to temporarily relieve minor pain. Whether you're dealing with a headache, muscle ache, or other types of discomfort, it can help ease your symptoms for a short period. Always remember to follow the recommended guidelines for use to ensure safety and effectiveness.

Dosage and Administration

For adults and children 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 three applications within a 24-hour period to ensure safety and effectiveness.

If you are considering this medication for a child who is 12 years old or younger, it’s important to consult a doctor first. They can provide guidance on the appropriate use and dosage for younger patients.

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, on cut, irritated, or swollen skin, or on puncture wounds. Additionally, avoid using it for more than one week without consulting your doctor. Be careful to keep it away from your eyes, and do not cover the treated area with bandages or apply local heat, such as heating pads.

By following these guidelines, you can help ensure that you use the medication effectively and safely. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider for more information.

Side Effects

It's important to use this product only on the skin and not for any other purpose. If your condition worsens, or if your symptoms last longer than 7 days or improve and then return within a few days, you should stop using the product and consult a doctor.

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 if you find that you need to use it for more than one week, it's important to consult your doctor first.

You should stop using the product and call your doctor if your condition worsens, if your symptoms last longer than 7 days, or if they improve and then come back within a few days. If the product is swallowed, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose of this medication, it's important to stay calm and take immediate action. While the drug insert does not provide specific information about overdose, you should be aware of general signs that may indicate an overdose, such as unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get professional assistance if you think something is wrong.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to consult with a healthcare professional before using this medication. They can provide guidance tailored to your specific situation and help you understand any potential risks. Always prioritize your health and the health of your baby by seeking expert advice.

Lactation 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 any potential risks and help ensure the safety of both you and your baby. Always prioritize open communication with your healthcare provider regarding your breastfeeding journey.

Pediatric Use

If you are considering this medication for a child who is 12 years old or younger, it’s important to consult with a doctor first. This ensures that the treatment is safe and appropriate for your child's specific needs. Always prioritize professional guidance when it comes to the health of your little ones.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to discuss any new prescriptions with your healthcare provider. They can help ensure that the medication is safe and appropriate for you or your loved one, considering any existing health conditions or other medications being taken.

If you have concerns about how this medication might affect you or an older adult in your care, don’t hesitate to ask your doctor or pharmacist for more information. They can provide guidance tailored to individual health situations.

Renal Impairment

If you have kidney 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 for the medication do not include special monitoring or safety considerations tailored for patients with 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 kidney health. They can provide guidance based on your individual situation.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include any specific guidelines about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no established recommendations for how your liver health might affect the use of this medication.

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

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 potential issues.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep it in a clean environment to ensure it remains safe for use. If you have any questions about disposal or other safety measures, refer to the guidelines provided with your product.

Additional Information

For adults and children over 12 years old, you should apply a thin layer of the medication to the affected area every 6 to 8 hours, but do not exceed 3 applications in a 24-hour period. If the patient is 12 years old or younger, it’s important to consult a doctor before use.

FAQ

What is Globe Lidocaine Cream used for?

Globe Lidocaine Cream temporarily relieves minor pain.

How should I apply Globe Lidocaine 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.

What should I do if I am using Globe Lidocaine Cream on a child under 12?

If the patient is 12 years or younger, you should ask a doctor before use.

Are there any precautions I should take when using this cream?

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

What should I avoid while using Globe Lidocaine Cream?

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

What should I do if my condition worsens or symptoms persist?

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

What should I do in case of accidental ingestion?

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

Can I use Globe Lidocaine Cream if I am pregnant or breastfeeding?

You should ask a health professional before using Globe Lidocaine Cream if you are pregnant or breastfeeding.

How should I store Globe Lidocaine Cream?

Store Globe Lidocaine Cream at room temperature.

Packaging Info

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

Packaging configurations for Pain Itch Relief.
Details

Drug Information (PDF)

This file contains official product information for Pain Itch Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Globe Lidocaine Cream is a topical formulation containing lidocaine as the active ingredient. The product is presented in a cream dosage form, with a total net weight of 49.6 grams. The formulation is designed for local anesthetic use, providing temporary relief from pain and discomfort in targeted areas.

Uses and Indications

This drug is indicated for the temporary relief of minor pain. It is suitable for use in patients experiencing mild discomfort due to various conditions.

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 of age or younger, it is advised 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 not recommended due to the potential for increased absorption and adverse effects. The product should not be applied to puncture wounds, as this may lead to complications. Prolonged use beyond one week without consulting a healthcare professional is contraindicated to prevent potential adverse reactions. Contact with the eyes must be avoided to prevent irritation or injury. Additionally, the product should not be bandaged or subjected to local heat, such as heating pads, as this may enhance absorption and increase the risk of side effects.

Warnings and Precautions

For external use only. This product is intended solely for topical application and should not be ingested.

General precautions must be observed to ensure safe use. The product should not be applied to large areas of the body or on cut, irritated, or swollen skin. Additionally, it is contraindicated for use on puncture wounds. Prolonged use beyond one week is not recommended without prior consultation with a healthcare professional.

Healthcare providers should advise patients to discontinue use and seek medical attention if the condition worsens, if symptoms persist for more than seven 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 local Poison Control Center should be contacted without delay.

Side Effects

For external use only. Patients should be advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days.

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 Pain Itch Relief (lidocaine hci). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Itch Relief.
Details

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

Geriatric Use

There is no specific information available 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy.

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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of specific guidance necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for 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 context of overdosage, it is important to note that the available sections of the drug insert do not provide specific information regarding potential overdosage scenarios.

Healthcare professionals are advised to exercise caution and consider the possibility of overdosage when administering the medication. In the absence of detailed guidance, it is recommended that clinicians monitor patients closely for any unusual symptoms or adverse reactions that may arise following administration.

In the event of suspected overdosage, standard supportive measures should be implemented. This includes ensuring the patient's safety, providing symptomatic treatment, and considering the need for further medical intervention based on the clinical presentation.

Healthcare providers are encouraged to report any cases of overdosage to the appropriate regulatory authorities to contribute to the ongoing assessment of the drug's safety profile.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. Patients should be informed that the product should not be applied to large areas of the body, on cut, irritated, or swollen skin, or on puncture wounds.

It is important to counsel patients against using the product for more than one week without consulting a doctor. They should be made aware that if their condition worsens or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, they should seek medical advice.

Patients must be instructed to use the product only as directed and to avoid contact with the eyes. Additionally, they should be cautioned not to bandage the area of use or apply local heat, such as heating pads, to the treated area.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

For adults and children over 12 years, the recommended administration involves applying a thin layer to the affected area every 6 to 8 hours, with a maximum of 3 applications within a 24-hour period. For children aged 12 years or younger, it is advised to consult a doctor before 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 Itch 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 Itch 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.